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High-speed air turbine handpiece / Low-speed air turbine handpiece
FDA 510(k)Class I (US FDA 510(k))
510(k) K181691
Identifiers
- 510(k) Number
- K181691 FDA 510(k)
- FDA Product Code
- EFB FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.4200 FDA 510(k)
- Regulation Number
- 872.4200 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
High-speed air turbine handpiece / Low-speed air turbine handpiece by Foshan Wenjian Medical Instrument Co., Ltd. — Class I — FDA_510K — listed in FDA 510(k)
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K181691 | Class I | Active |
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Manufacturer
- Manufacturer
- Foshan Wenjian Medical Instrument Co., Ltd.
Sources (1)
- FDA 510(k) K181691 24 fields · synced Jun 18, 2026