(322 days)
No
The device description explicitly states "The device is not software driven device". Additionally, there are no mentions of AI, DNN, or ML, and the performance studies focus on mechanical and biological standards, not algorithmic performance.
No
The device is used to remove carious material and prepare teeth, which is a restorative rather than a therapeutic function.
No
The device's intended use is for removing material and preparing teeth, which are therapeutic and restorative actions, not diagnostic.
No
The device description explicitly states, "The device is not software driven device, does not include drill." It is a physical, air-driven handpiece.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Function: The description clearly states that the device is a "High-speed Turbine Handpiece" used for mechanical procedures on teeth (removing material, preparing cavities, etc.). It operates using compressed air to rotate a drill.
- Lack of Biological Sample Analysis: There is no mention of the device being used to analyze biological samples or provide diagnostic information based on such analysis. Its function is purely mechanical and procedural.
The information provided aligns with a dental instrument used for treatment, not a diagnostic test performed outside the body.
N/A
Intended Use / Indications for Use
High-speed Turbine Handpieces for Single Use are 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
EFB
Device Description
The High-speed Turbine Handpieces for Single Use uses compressed air as power source which drives the wind wheel in the head to make drill rotating at very high speed for teeth cutting.
The proposed devices have 12 models difference includes: the size of head, methods of loading the drill, types of coupling, and shape of the shank.
The High-speed Turbine Handpieces for Single Use are single use device. The device is not software driven device, does not include drill.
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:
- A ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process;
- A ISO 10993-5: 2009 Biological evaluation of medical device - Part 5: Tests for in vitro cytotoxicity;
-
ISO 10993-10: 2010 Biological evaluation of medical device – Part 10: Tests for irritation and skin sensitization:
-
ISO 14457: 2012 Dentistry- Handpieces and Motors
-
ISO 9168:2009 Dentistry- Hose Connectors for air driven dental handpieces
-
ASTM F88/F88M-15: Standard test method for seal strength of flexible barrier materials;
- ISO 11137-2:2013 Sterilization of health care products-Radiation-Part 2: Establishing the > sterilization dose;
- Guidance for Industry and FDA Staff- Dental Handpieces Premarket Notification [510(k)] A Submissions
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 contains the logos of the Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is in blue and includes the words "FDA U.S. FOOD & DRUG ADMINISTRATION".
Beijing Dongbo Dental Handpiece Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O.box 120-119 Shanghai, 200120 Cn
July 11, 2018
Re: K172543
Trade/Device Name: High-speed Turbine Handpieces for Single Use Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I Product Code: EFB Dated: May 29, 2018 Received: June 7, 2018
Dear Diana Hong:
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. 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.
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
1
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mary S. Runner -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172543
Device Name
High-speed Turbine Handpieces for Single Use
Indications for Use (Describe)
High-speed Turbine Handpieces for Single Use are intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations, root canal preparations and polishing teeth.
Type of Use (Select one or both, as applicable)|X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: K172543
-
- Date of Preparation: 05/29/2018
-
- Sponsor Identification
Beijing Dongbo Dental Handpiece Co., Ltd
Room 201, Building 4, No.9 Anqing Street, Area B of Tianzhu Airport Industrial Zone, Shunyi District, Beijing, 101318, China
Establishment Registration Number: Not yet registered
Contact Person: Chengfei Yan Position: Management representative Tel: +86-10-80479758 Fax: +86-10-80478329 Email: 593893102@qq.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd
P.O. Box 120-119, Shanghai, 200120, China Tel: +86(0)21 2281-5850 Fax: +1(0)360 925-3199 Email: info@mid-link.net
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Identification of Proposed Device 4.
Trade Name: High-speed Turbine Handpieces for Single Use Common Name: Handpiece, Air-Powered, Dental Model(s): TBY03-BK, TBY03-BKJ, TBY03-BZJ, TBY03-BZJW, TBY03-BKJW, TBY03-DK, TBY03-DKJ, TBY03-DZJ, TBY03-DZJW, TBY03-DKJW, TBY04-DKJ, TBY04-DZJ
Regulatory Information
Classification Name: Handpiece, Air-Powered, Dental Classification: I Product Code: EFB Regulation Number: 21CFR 872.4200 Review Panel: Dental
Intended Use Statement:
High-speed Turbine Handpieces for Single Use are 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
The High-speed Turbine Handpieces for Single Use uses compressed air as power source which drives the wind wheel in the head to make drill rotating at very high speed for teeth cutting.
The proposed devices have 12 models difference includes: the size of head, methods of loading the drill, types of coupling, and shape of the shank.
The High-speed Turbine Handpieces for Single Use are single use device. The device is not software driven device, does not include drill.
ર . Identification of Predicate Device(s)
Primary Predicate device 510(k) Number: K152146 Product Name: High Speed Handpieces and Accessories
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Reference device
510(k) Number: K153411
Product Name: 430 SW Torque High Speed Handpiece Series
-
Non-Clinical Test Conclusion 6.
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: -
A ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process;
-
A ISO 10993-5: 2009 Biological evaluation of medical device - Part 5: Tests for in vitro cytotoxicity;
-
ISO 10993-10: 2010 Biological evaluation of medical device – Part 10: Tests for irritation and skin sensitization:
-
ISO 14457: 2012 Dentistry- Handpieces and Motors
-
ISO 9168:2009 Dentistry- Hose Connectors for air driven dental handpieces
-
ASTM F88/F88M-15: Standard test method for seal strength of flexible barrier materials;
-
ISO 11137-2:2013 Sterilization of health care products-Radiation-Part 2: Establishing the > sterilization dose;
-
Guidance for Industry and FDA Staff- Dental Handpieces Premarket Notification [510(k)] A Submissions
-
- Clinical Test Conclusion
No clinical study is included in this submission.
-
- Substantially Equivalent (SE) Comparison
| Item | Proposed Device | Primary Predicate Device
K152146 | Reference Device
K153411 |
|-------------------|-----------------|-------------------------------------|-----------------------------|
| Classification | I | I | I |
| Product Code | EFB | EFB | EFB |
| Regulation Number | 872.4200 | 872.4200 | 872.4200 |
| Intended Use | High-speed | Turbine High Speed Hnadpieces and | The 430 Torque High-Speed |
Table 1 Comparison of Technology Characteristics
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| Handpieces for Single Use are intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth. | Accessories are intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth. | Handpieces Series are used by trained dental professionals for a variety of procedures including but not limited to caries and amalgam removal, restorative work and crown preparation. | ||
|---|---|---|---|---|
| Operational modes | Air-powered | Air-powered | Air-powered | |
| Material composition | Brass, Aluminum, ABS | Stainless steel, Brass, Aluminum, Titanium | Stainless steel, Aluminum, Optional bead blasted outer surface | |
| Air / Water spray | Water | Water | Water | |
| Water cooling | Yes | Not known | Yes | |
| Fiber optics | Without light | With light/without light | Without light | |
| Coupling | Quick coupling/4-hole coupling | 2-hole/4-hole/5-hole/6-hole coupling | Quick coupling | |
| Type of connectors | Hose connection | Hose connection | Hose connection | |
| Speed in rpms | 350000 rpm / 380000 rpm | 350000 rpm to 400000 rpm | 350000 rpm to 450000 rpm | |
| Bur extraction force | >22N / | |||
| 22N-45N | 22N-45N | Unknown | ||
| Single use | Yes | No | No | |
| Sterilization | Radiation / SAL 10-6 | Moist heat / SAL 10-6 | Moist heat / SAL 10-6 | |
| Biocompatibility | Cytotoxicity | No Cytotoxicity | Compliance with ISO 10993 requirements | Compliance with ISO 10993 requirements |
| Intracutaneous Reactivity | No Intracutaneous Reactivity | |||
| Skin Sensitization | No Skin Sensitization | |||
| Performance | Compliance with ISO 14457:2012 and ISO 9168:2009 | Compliance with ISO 14457:2012 and ISO 9168:2009 | Compliance with ISO 14457:2012 |
Discussion: The main difference between the proposed device and predicate device is whether a single use device. The proposed device is single used and sterilized by the manufacturer and the sterilization cycle has been validated per ISO 11137-2. The predicate devices are reusable and would be re-sterilized by users. The re-sterilization would be influence or reduce the safety and performance of predicate device, while this would not be occur to the proposed device. Additionally, there are some slight 4 / 5
7
differences of device design between proposed device and predicate devices, but both the proposed device and predicate devices comply with ISO 14457 and ISO 9168. Therefore, the differences will not affect the substantially equivalency.
- Substantially Equivalent (SE) Conclusion 9.
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.