September 22, 2023
Foshan COXO Medical Instrument Co., Ltd.
℅ Ray Wang
Official Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd.,
FangShan District
Beijing, Beijing 102401
China
Re: K220179
Trade/Device Name: High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle
Handpieces/Air Motors
Regulation Number: 21 CFR 872.4200
Regulation Name: Dental Handpiece And Accessories
Regulatory Class: Class I, reserved
Product Code: EFB, EGS
Dated: September 1, 2023
Received: September 1, 2023
Dear Ray Wang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced
above and have determined the device is substantially equivalent (for the indications for use stated in the
enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the
enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance
with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a
premarket approval application (PMA). You may, therefore, market the device, subject to the general
controls provisions of the Act. Although this letter refers to your product as a device, please be aware that
some cleared products may instead be combination products. The 510(k) Premarket Notification Database
located at [Link] identifies combination
product submissions. The general controls provisions of the Act include requirements for annual registration,
listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and
adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We
remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be
subject to additional controls. Existing major regulations affecting your device can be found in the Code of
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements
concerning your device in the Federal Register.
U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID# 04017.06.03
Silver Spring, MD 20993
[Link]
K220179 - Ray Wang Page 2
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA
has made a determination that your device complies with other requirements of the Act or any Federal
statutes and regulations administered by other Federal agencies. You must comply with all the Act's
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
[Link]
combination-products); good manufacturing practice requirements as set forth in the quality systems (QS)
regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for
combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-
542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part
803), please go to [Link]
mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including
information about labeling regulations, please see Device Advice ([Link]
devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn
([Link] Additionally, you may contact the
Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
the DICE website ([Link]
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE
by email (DICE@[Link]) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Bobak
Shirmohammadi -S
For Michael E. Adjodha, M. ChE., CQIA
Assistant Director
DHT1B: Division of Dental and
ENT Devices
OHT1: Office of Ophthalmic, Anesthesia,
Respiratory, ENT and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: 0MB No. 0910-0120
Food and Drug Administration Expiration Date: 06/30/2023
Indications for Use See PRA Statement below.
51 0(k) Number (if known)
K220179
Device Name
High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors
Indications for Use (Describe)
High-Speed Air Turbine Handpieces:
It is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth
preparations and restorations, root canal preparations and polishing teeth.
Straight Handpieces:
It is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth
preparations and restorations, root canal preparations and polishing teeth.
Geared Angle Handpieces:
It is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth
preparations and restorations, root canal preparations and polishing teeth.
Air Motors:
It is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth
preparations and restorations, root canal preparations and polishing teeth.
Type of Use (Select one or both, as applicable)
IZI Prescription Use (Part 21 CFR 801 Subpart D) D Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@[Link]
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid 0MB number."
FORM FDA 3881 (6120) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
510(k) Summary
510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section
807.92.
The assigned 510(k) Number: K220179
1. Date of Preparation
09/21/2023
2. Sponsor
Foshan COXO Medical Instrument Co., Ltd.
BLDG 4, District A Guangdong New Light Source Industrial Base, South of Luocun Avenue
Nanhai District Foshan 528226 Guangdong China
Contact Person: Zheng yongjian
Position: Legal Representative
Tel: 13702544788
Fax: 0757-81800058
Email: 13702544788@[Link]
3. Submission Correspondent
Mr. Ray Wang
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District，Beijing City, China,
102401
Tel: +86-18910677558
Fax: +86-10-56335780
Email: information@[Link]
Page 1 of 8
510(k) Summary
4. Identification of Proposed Device
Trade Name: High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/
Air Motors
Common Name: Dental Handpiece and Accessories
Model(s):
High-Speed Air Turbine Handpieces
CX207, CX207-G, CX207-2, CX207-A, CX207-A-2, CX207-B, CX207-B-2, CX207-C,
CX207-C-2, CX207-W, CX207-W-2
Straight Handpieces
CX235-2, CX235-2A, CX235-2B, CX235-2F, CX235-2G, CX235-2C, CX235- 2S2
Geared Angle Handpieces
CX235-1B, CX235-1C, CX235-1F, CX235-1G, CX235C1, CX235C2, CX235C3, CX235C4,
CX235C5, CX235C6, CX235C7, CX235C8, CX235-2S, CX235-2S1
Air Motors:
CX235-3B, CX235-3F, CX235-3C
Regulatory Information:
Regulation Name: Dental Handpiece And Accessories
Classification: I;
Product Code: EFB;
Additional Product Code: EGS;
Regulation Number: 21 CFR 872.4200;
Review Panel: Dental;
Indications for Use Statement:
High-Speed Air Turbine Handpieces:
It is intended for removing carious material, excess filling material, cavity and crown preparation,
finishing tooth preparations and restorations, root canal preparations and polishing teeth.
Straight Handpieces:
It is intended for removing carious material, excess filling material, cavity and crown preparation,
finishing tooth preparations and restorations, root canal preparations and polishing teeth.
Geared Angle Handpieces:
It is intended for removing carious material, excess filling material, cavity and crown preparation,
finishing tooth preparations and restorations, root canal preparations and polishing teeth.
Air Motors:
Page 2 of 8
510(k) Summary
It is intended for removing carious material, excess filling material, cavity and crown preparation,
finishing tooth preparations and restorations, root canal preparations and polishing teeth.
5. Device Description
The proposed device is used to hold rotary instruments such as burs and drills for cutting, grinding,
and drilling operations. The dental handpieces are hand-held instruments driven by air motor, thus
driving the rotation of dental attachments for the purpose of drilling and tooth cutting. Some models
include an electric connection to power an LED light
6. Identification of Predicate Device
Primary Predicate Device:
510(k) Number: K181691
Product Name: High-Speed Air Turbine Handpiece / Low-Speed Air Turbine Handpiece
Manufacturer: Foshan Wenjian Medical Instrument Co., Ltd.
Reference Device:
510(k) Number: K202786
Product Name: Dental Low-speed Handpieces and Accessories
Manufacturer: MicroP Technology (Taiwan), Inc.
7. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as
was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the
proposed device complies with the following standards:
➢ ANSI/AAMI ES60601-1:2005/(R)2012 And A1:2012, Medical Electrical Equipment - Part 1:
General Requirements For Basic Safety And Essential Performance;
➢ IEC 60601-1-2:2014, Medical electrical equipment- Part 1-2: General requirements for basic
safety and essential performance- Collateral standard: Electromagnetic compatibility-
Requirements and tests;
➢ IEC 80601-2-60: 2019, Medical electrical equipment - Part 2-60: Particular requirements for
the basic safety and essential performance of dental equipment;
➢ ISO 10993-5:2009, Biological Evaluation of Medical Device-Part 5: Tests for Vitro
cytotoxicity;
➢ ISO 10993-10:2021, Biological Evaluation of Medical Device-Part 10: Test for irritation and
delay-type hypersensitivity;
➢ ISO 10993-23:2021, Biological Evaluation of Medical Device – Part 23: Tests for irritation;
➢ ISO 10993-11:2017, Biological Evaluation of Medical Device – Part 11: Test for systemic toxicity;
➢ Pyrogen Study in Rabbits using USP General Chapter <151> Pyrogen Test;
➢ ISO 14457 Second edition 2017-10 Dentistry - Handpieces and motors;
Page 3 of 8
510(k) Summary
➢ ISO 17664 Second edition 2017-10 Processing of health care products - Information to be
provided by the medical device manufacturer for the processing of medical devices
➢ ISO 17665-1 First edition 2006-08-15 Sterilization of health care products - Moist heat - Part 1:
Requirements for the development, validation and routine control of a sterilization process for
medical devices
➢ ISO 9168 Third edition 2009-07-15 Dentistry - Hose connectors for air driven dental
handpieces
8. Clinical Test Conclusion
No clinical study is included in this submission.
Page 4 of 8
510(k) Summary
9. Substantially Equivalent (SE) Comparison
Table 7-3 General Comparison
ITEM Proposed Device Primary Predicate Device Reference Device Remark
Manufacturer Foshan COXO Medical Instrument Co., Ltd. Foshan Wenjian Medical MicroP Technology (Taiwan), Inc. --
Instrument Co., Ltd.
Device Name High-Speed Air Turbine Handpieces/ Straight Handpieces/ Geared Angle High-speed air turbine handpiece Dental Low-speed Handpieces and --
Handpieces/ Air Motors Low-speed air turbine handpiece Accessories
Model High-Speed Air Turbine Handpieces:CX207, CX207-G, CX207-2, Dental High-speed Turbine Contra-angle Handpieces: G25, G25L, --
CX207-A, CX207-A-2, CX207-B, CX207-B-2, CX207-C, CX207-C-2, Handpiece (WJ-114, WJ- 112, G23
CX207-W, CX207-W-2 WJ-124, WJ -122, WJ- 134, WJ Straight Handpieces: G65, G65L, G63
Straight Handpieces: CX235-2, CX235-2A, CX235-2B, CX235-2F, -132, WJ - 144, WJ -142, WJ
CX235-2G, CX235-2C, CX23 5- 2S2 -154, WJ - 152, WJ -164, WJ
Geared Angle Handpieces: CX235-1B, CX235-1C, CX235-1F, -162)
CX235-1G, CX235C1, CX235C2, CX235C3, CX235C4, CX235C5, Dental Low-speed Turbine
CX235C6, CX235C7, CX235C8, CX235-2S, CX235-2S1 Handpiece (WJ-414, WJ- 412,
Air Motors:CX235-3B, CX235-3F, CX235-3C WJ-424, WJ-422)
Product Code EFB, EGS EFB, EGS EFB, EGS SAME
Regulation No. 21 CFR 872.4200 21 CFR 872.4200 21 CFR 872.4200 SAME
Class I I I SAME
Indication High-Speed Air Turbine Handpieces: Dental High-speed Turbine MicroP Dental Low-speed Handpieces SAME
It is intended for removing carious material, excess filling material, cavity Handpiece (WJ-114, WJ- 112, and Accessories is intended for removing
and crown preparation, finishing tooth preparations and restorations, root WJ-124, WJ -122, WJ- 134, WJ carious material, excess filling material,
canal preparations and polishing teeth. -132, WJ - 144, WJ -142, WJ cavity and crown preparation, finishing
-154, WJ - 152, WJ -164, WJ tooth preparations and restorations, root
Straight Handpieces: -162) is intended for removing canal preparations and polishing teeth.
It is intended for removing carious material, excess filling material, cavity carious material, excess filling All the devices are designed for use by a
and crown preparation, finishing tooth preparations and restorations, root material, cavity and crown trained professional in the field of
canal preparations and polishing teeth. preparation, finishing tooth general dentistry
preparations and restorations, root
Page 5 of 8
510(k) Summary
Geared Angle Handpieces: canal preparations and polishing
It is intended for removing carious material, excess filling material, cavity teeth.
and crown preparation, finishing tooth preparations and restorations, root Dental Low-speed Turbine
canal preparations and polishing teeth. Handpiece (WJ-414, WJ- 412,
Air Motors: WJ-424, WJ-422) is intended for
It is intended for removing carious material, excess filling material, cavity removing carious material, excess
and crown preparation, finishing tooth preparations and restorations, root filling material, cavity and crown
canal preparations and polishing teeth. preparation, finishing tooth
preparations and restorations, root
canal preparations and polishing
teeth.
Air/water ports 2/4/6 ports 2/4 ports up to four DIFFERENT 1
Fiberoptic Glass Rod CX207-G, CX235-1C, CX235C7 Included in model WJ-162, Included in model G25Land G65L SAME
WJ-164, WJ-424
and WJ- 422Disposable
Accessories NA NA NA SAME
Composition of material Copper (chromium plating), aluminum , rubber and stainless steel Stainless steel, Brass, Aluminum, Stainless steel, Aluminum Alloy DIFFERENT 2
Titanium
Chuck Push button, Screw Push button, Screw Push button SAME
Bur extraction force 22N 28N / DIFFERENT 3
0.248-0.296MPa
Maximum air pressure High-speed Air Turbine Handpieces:0.2-0.25Mpa Dental High-speed Turbine (36psi~43psi) SAME
Handpiece: 200kPa ~ 250kPa
Straight handpiece & Geared Angle handpiece & Air Motors:0.245MPa
~0.3925MPa (29.01 psi~ 36.25 psi) Dental
Low-speed Turbine Handpiece:
245 ~ 392 kPa (35.53 psi~ 56.85
psi)
Page 6 of 8
510(k) Summary
High-Speed Air Turbine Handpieces: Dental High-speed Turbine 0.248-0.296MPa
Maximum water SAME
0.2-0.25Mpa Handpiece: 200kPa ~ 250kPa (36psi~43psi)
pressure
(29.01 psi~ 36.25 psi)
Straight handpiece & Geared Angle handpiece & Air Motors:0.245MPa
~0.3925MPa Dental Low-speed Turbine
Handpiece: 245 ~ 392 kPa (35.53
psi~ 56.85 psi)
Speed in rpms High-speed Air Turbine Handpieces:280000 ~ Dental High-speed Turbine ＜40000rpm DIFFERENT 4
450000 Handpiece: 300,000rpm ~
400,000rpm
Straight handpiece &Geared Angle handpiece
&Air Motors:＜40000rpm Dental Low-speed Turbine
Handpiece: 18,000 ~ 20,000 rpm
Conformance with Type 3 per ISO 1797-1 Type 3 per ISO 1797-1 / SAME
standards for shanks
Coupling dimensions Complied with ISO 3964 Complied with ISO 3964 / SAME
Hose connections Type 1 for 2-hole model / Type 2 for 4- hole Type 1 for 2-hole model / Type 2 / SIMILAR
model/Type 3 for 6-hole model for 4- hole model
Lubricant The lubricants approved by FDA, such as DO-ALL Dental Handpiece The specified lubricant, type MicroP Halley Spray SIMILAR
Lubricant “PANA SPRAY Plus”
(K073353). manufactured by NAKANISHI
INC (cleared in K163483), must
be used during routine
maintenance.
Compliance Standards Complied with ISO 10993- 5, ISO 10993-10, ISO 10993-23, ISO Complied with ISO 10993- 5, ISO Complied with ISO 10993- 5, ISO SAME
10993-11, USP <151> Pyrogen Testing, IEC 60601-1, IEC 60601-1-2, IEC 10993-10, IEC 60601-1, IEC 10993-10, ISO14457
80601- 2-60, ISO14457, ISO 17665-1, ISO 17664, ISO 9168 80601- 2-60, ISO14457, ISO
17665, ISO 11138, ISO 11607,
ISO 17664
Page 7 of 8
510(k) Summary
10. Substantially Equivalent (SE) Conclusion
DIFFERENT 1
The difference between proposed device and predicate device is Air/water ports, which is use for
connection, the difference does not affect the safety and effectiveness of proposed device. Based on
the nonclinical tests performed, the proposed device is as safe, as effective, and performs as well as
the legally marketed predicate device.
DIFFERENT 2
The Handpiece is tissue-contacting, so it is tested accordance with the requirements of ISO 10993-1
and guidelines. The test results meet the requirements. Based on the biological test results, the
proposed device is as safe, and performs as well as the legally marketed predicate device.
DIFFERENT 3
The difference between proposed device and predicate device is bur extraction force. The ISO 14457
required the bur extraction force shall be at least 22 N for Type 5. Based on the nonclinical tests
performed, the proposed device meets the standard and is as safe, as effective, and performs as well
as the legally marketed predicate device.
DIFFERENT 4
The difference between proposed device and predicate device is Speed. The proposed device’s speed
range is covered by the Predicate Device’s speed range. Therefore, the proposed device’s speed range
can meet the use requirement. We tested as ISO 14457, based on the nonclinical tests performed, the
proposed device is as safe, as effective, and performs as well as the legally marketed predicate
device.
Conclusion: Based on the comparison of technological characteristics, demonstrated through bench
testing and intended use, the proposed device is substantially equivalent to the predicate device.
Page 8 of 8
