StarDental 266653
StarDental 266653 is a Class I device made by Dentalez, Inc., cleared under FDA 510(k) K153411 on 8 Apr 2016 and listed in FDA GUDID since 22 Apr 2026 (UDI-DI D7022666530), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberD7022666530 | Date22 Apr 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK153411 | Date8 Apr 2016 | StatusActive |
Official records
- FDA 510(k) database K153411
Across registries
- FDA 510(k) K153411 decided 8 Apr 2016 Active
- FDA GUDID UDI-DI D7022666530 listed 22 Apr 2026 Listed
Timeline
- Cleared FDA 510(k) K153411
- Listed FDA GUDID D7022666530
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- StarDental
- Generic name
- Dental surgical power tool motorized handpiece/set, pneumatic
- Model / Ref / Catalog
- 266653
- Primary DI / UDI-DI
- D7022666530
- 510(k) Number
- FDA product code
- EFB
- GMDN term
- Dental surgical power tool motorized handpiece/set, pneumatic
- Device class
- Class I
- Regulation number
- 872.4200
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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