BIstite II DC 16308
by Tokuyama Dental Corporation
BIstite II DC 16308 is a Class II device made by Tokuyama Dental Corporation, cleared under FDA 510(k) K011685 on 31 Jul 2001 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 04548190163083), active as of 23 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 | Number04548190163083 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK011685 | Date31 Jul 2001 | StatusActive |
Official records
- AccessGUDID record 04548190163083
- FDA 510(k) database K011685
Across registries
- FDA 510(k) K011685 decided 31 Jul 2001 Active
- FDA GUDID UDI-DI 04548190163083 listed 23 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K011685
- Listed FDA GUDID 04548190163083
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- BIstite II DC
- Generic name
- Dental composite resin
- Model / reference
- 16308
- Primary DI / UDI-DI
- 04548190163083
- 510(k) Number
- FDA product code
- EMA
- GMDN term
- Dental composite resin
- Device class
- Class II
- Regulation number
- 872.3275
- GUDID distribution status
- In Commercial Distribution
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