(609 days)
No
The device description and intended use are for standard dental handpieces and motors, and there is no mention of AI, ML, or any related technologies in the provided text.
No.
The device descriptions and intended uses, such as removing carious material, preparing cavities, and polishing teeth, describe mechanical actions for dental procedures rather than therapeutic treatment of a disease or condition.
No
The device is intended for removing carious material, excess filling material, preparing cavities and crowns, finishing restorations, and polishing teeth, which are all treatment-oriented procedures rather than diagnostic ones.
No
The device description explicitly states it is a hand-held instrument driven by an air motor and includes an electric connection for an LED light, indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes procedures performed directly on the patient's teeth (removing material, preparing cavities, polishing, etc.). This is a direct clinical intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The device is described as holding rotary instruments for cutting, grinding, and drilling operations on teeth. This aligns with the intended use of a dental handpiece used in clinical procedures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely focused on mechanical manipulation of tooth structure within the patient's mouth.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
EFB, EGS
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 Pyrogen Test;
- ISO 14457 Second edition 2017-10 Dentistry - Handpieces and motors;
- 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm 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.
1
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 of medical device-related adverse events) (21 CFR 803) for
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) 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
2
Indications for Use
510(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)
| ☑ Remediation Use (Part 21 CFR 601.3 Subpart D) |
|---|
| ☐ Own-Use Exception (21 CFR 601.3 Subpart C) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
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
-
Date of Preparation 1.
09/21/2023 -
- 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@163.com
-
- Submission Correspondent
Mr. Ray Wang
- Submission Correspondent
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@believe-med.com
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
- Identification of Proposed Device
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:
5
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.
Device Description 5.
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.
-
Non-Clinical Test Conclusion 7.
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 Pyrogen Test;
-
A ISO 14457 Second edition 2017-10 Dentistry - Handpieces and motors;
6
-
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
-
- Clinical Test Conclusion
No clinical study is included in this submission.
7
9. Substantially Equivalent (SE) Comparison
| ITEM | Proposed Device | Primary Predicate Device | Reference Device | Remark | |
|---|---|---|---|---|---|
| Manufacturer | Foshan COXO Medical Instrument Co., Ltd. | Foshan Wenjian Medical | |||
| Instrument Co., Ltd. | MicroP Technology (Taiwan), Inc. | -- | |||
| Device Name | High-Speed Air Turbine Handpieces/ Straight Handpieces/ Geared Angle | ||||
| Handpieces/ Air Motors | High-speed air turbine handpiece | ||||
| Low-speed air turbine handpiece | Dental Low-speed Handpieces and | ||||
| Accessories | -- | ||||
| Model | 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, CX23 5-2S2 | |||||
| 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 | Dental High-speed Turbine | ||||
| Handpiece (WJ-114, WJ- 112, | |||||
| WJ-124, WJ -122, WJ- 134, WJ | |||||
| -132, WJ - 144, WJ -142, WJ | |||||
| -154, WJ - 152, WJ -164, WJ | |||||
| -162) | |||||
| Dental Low-speed Turbine | |||||
| Handpiece (WJ-414, WJ- 412, | |||||
| WJ-424, WJ-422) | Contra-angle Handpieces: G25, G25L, | ||||
| G23 | |||||
| Straight Handpieces: G65, G65L, G63 | -- | ||||
| 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: | ||||
| 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. | Dental High-speed Turbine | ||||
| Handpiece (WJ-114, WJ- 112, | |||||
| WJ-124, WJ -122, WJ- 134, WJ | |||||
| -132, WJ - 144, WJ -142, WJ | |||||
| -154, WJ - 152, WJ -164, WJ | |||||
| -162) is intended for removing | |||||
| carious material, excess filling | |||||
| material, cavity and crown | |||||
| preparation, finishing tooth | |||||
| preparations and restorations, root | MicroP Dental Low-speed Handpieces | ||||
| and Accessories is intended for removing | |||||
| carious material, excess filling material, | |||||
| cavity and crown preparation, finishing | |||||
| tooth preparations and restorations, root | |||||
| canal preparations and polishing teeth. | |||||
| All the devices are designed for use by a | |||||
| trained professional in the field of | |||||
| general dentistry | SAME | ||||
| 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. | canal preparations and polishing | ||||
| teeth. | |||||
| Dental Low-speed Turbine | |||||
| Handpiece (WJ-414, WJ- 412, | |||||
| WJ-424, WJ-422) 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/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, | |||
| WJ-164, WJ-424 | |||||
| and WJ- 422Disposable | Included in model G25Land G65L | SAME | |||
| Accessories | NA | NA | NA | SAME | |
| Composition of material | Copper (chromium plating), aluminum , rubber and stainless steel | Stainless steel, Brass, Aluminum, | |||
| Titanium | Stainless steel, Aluminum Alloy | DIFFERENT 2 | |||
| Chuck | Push button, Screw | Push button, Screw | Push button | SAME | |
| Bur extraction force | 22N | 28N | / | DIFFERENT 3 | |
| Maximum air pressure | High-speed Air Turbine Handpieces:0.2-0.25Mpa |
Straight handpiece & Geared Angle handpiece & Air Motors:0.245MPa
0.3925MPa | Dental High-speed Turbine 36.25 psi) Dental
Handpiece: 200kPa ~ 250kPa
(29.01 psi
Low-speed Turbine Handpiece:
245 ~ 392 kPa (35.53 psi~ 56.85
psi) | 0.248-0.296MPa
(36psi~43psi) | SAME | |
| Maximum
pressure | water | High-Speed Air Turbine Handpieces:
0.2-0.25Mpa
Straight handpiece & Geared Angle handpiece & Air Motors:0.245MPa
0.3925MPa | Dental High-speed Turbine 36.25 psi)
Handpiece: 200kPa ~ 250kPa
(29.01 psi
Dental Low-speed Turbine
Handpiece: 245 ~ 392 kPa (35.53
psi~ 56.85 psi) | 0.248-0.296MPa
(36psi~43psi) | SAME |
| Speed in rpms | | High-speed Air Turbine Handpieces:280000 ~
450000
Straight handpiece &Geared Angle handpiece
&Air Motors: Pyrogen Testing, IEC 60601-1, IEC 60601-1-2, IEC
80601- 2-60, ISO14457, ISO 17665-1, ISO 17664, ISO 9168 | Complied with ISO 10993- 5, ISO
10993-10, IEC 60601-1, IEC
80601- 2-60, ISO14457, ISO
17665, ISO 11138, ISO 11607,
ISO 17664 | Complied with ISO 10993- 5, ISO
10993-10, ISO14457 | SAME |
Table 7-3 General Comparison
Page 5 of 8
8
9
10
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.