Identity
- Trade Name
- High-speed Turbine Handpieces for Single Use FDA UDI
- Generic Name
- Dental power tool system handpiece, pneumatic FDA UDI
- Model / Reference
- TBY04-DKJ FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970278690019 FDA UDI
- 510(k) Number
- K172543 FDA UDI
- FDA Product Code
- EFB FDA UDI
- GMDN Term
- Dental power tool system handpiece, pneumatic FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental power tool system handpiece, pneumatic
High-speed Turbine Handpieces for Single Use by Beijing Dongbo Dental Handpiece Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Dental power tool system handpiece, pneumatic.
- MK-dent Germany® — MK-Dent GmbH · Class I
- AG Neovo — ASSOCIATED INDUSTRIES CHINA, INC. · Class I
- MicroP Dental — Microp Technology (Taiwan), Inc. · Class I
- AG Neovo — ASSOCIATED INDUSTRIES CHINA, INC. · Class I
- SurgiPro — HENRY SCHEIN, INC. · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class I
- PROPHY SPORT — HANDPIECE PARTS & REPAIRS, INC. · Class I
- MK-dent Germany® — MK-Dent GmbH · Class I
Cleared under the same submission
K172543 also covers:
- High-speed Turbine Handpieces for Single Use — Beijing Dongbo Dental Handpiece Co., Ltd.
- High-speed Turbine Handpieces for Single Use — Beijing Dongbo Dental Handpiece Co., Ltd.
- High-speed Turbine Handpieces for Single Use — Beijing Dongbo Dental Handpiece Co., Ltd.
- High-speed Turbine Handpieces for Single Use — Beijing Dongbo Dental Handpiece Co., Ltd.
- High-speed Turbine Handpieces for Single Use — Beijing Dongbo Dental Handpiece Co., Ltd.
- High-speed Turbine Handpieces for Single Use — Beijing Dongbo Dental Handpiece Co., Ltd.
- High-speed Turbine Handpieces for Single Use — Beijing Dongbo Dental Handpiece Co., Ltd.
- High-speed Turbine Handpieces for Single Use — Beijing Dongbo Dental Handpiece Co., Ltd.
- High-speed Turbine Handpieces for Single Use — Beijing Dongbo Dental Handpiece Co., Ltd.
- High-speed Turbine Handpieces for Single Use — Beijing Dongbo Dental Handpiece Co., Ltd.
- High-speed Turbine Handpieces for Single Use — Beijing Dongbo Dental Handpiece Co., Ltd.
- High-speed Turbine Handpieces for Single Use — Beijing Dongbo Dental Handpiece Co., Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Beijing Dongbo Dental Handpiece Co., Ltd.
Sources (1)
- FDA UDI 76e4d648-9b3c-447d-8dcd-28a51956e761 33 fields · synced May 30, 2026