GC Reline™ 001526
GC Reline™ 001526 is a Class II device made by Gc America Inc., cleared under FDA 510(k) K990736 on 28 May 1999 and listed in FDA GUDID since 9 Sep 2016 (UDI-DI D0470015261), active (FDA 510(k)), not in commercial distribution (GUDID) 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 | NumberD0470015261 | Date9 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK990736 | Date28 May 1999 | StatusActive |
Official records
- FDA 510(k) database K990736
Across registries
- FDA 510(k) K990736 decided 28 May 1999 Active
- FDA GUDID UDI-DI D0470015261 listed 9 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K990736
- Listed FDA GUDID D0470015261
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- GC Reline™
- Generic name
- Dental mandrel
- Model / Ref / Catalog
- 001526
- Primary DI / UDI-DI
- D0470015261
- 510(k) Number
- FDA product code
- EBI
- GMDN term
- Dental mandrel
- Device class
- Class II
- Regulation number
- 872.3760
- GUDID distribution status
- Not in Commercial Distribution
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