StarDental 266343
StarDental 266343 is a Class I device made by Dentalez, Inc., cleared under FDA 510(k) K240183 on 19 Sep 2024 and listed in FDA GUDID since 20 Jun 2025 (UDI-DI D7022663430), 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 | NumberD7022663430 | Date20 Jun 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK240183 | Date19 Sep 2024 | StatusActive |
Official records
- FDA 510(k) database K240183
Across registries
- FDA 510(k) K240183 decided 19 Sep 2024 Active
- FDA GUDID UDI-DI D7022663430 listed 20 Jun 2025 Listed
Timeline
- Cleared FDA 510(k) K240183
- Listed FDA GUDID D7022663430
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- Withdrawn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, electric
- Model / reference
- 266343
- Description
- STAR E900 1:1 AL, FO, HANDPIECE
- Primary DI / UDI-DI
- D7022663430
- 510(k) Number
- FDA product code
- EGS
- GMDN term
- Dental surgical power tool motorized handpiece/set, electric
- 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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