GC Reline ™ 000598
GC Reline ™ 000598 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 1 Aug 2016 (UDI-DI D0470005981), 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 | NumberD0470005981 | Date1 Aug 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 D0470005981 listed 1 Aug 2016 Listed
Timeline
- Cleared FDA 510(k) K990736
- Listed FDA GUDID D0470005981
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- GC Reline ™
- Generic name
- Denture reliner, elastic, short-term
- Model / Ref / Catalog
- 000598
- Primary DI / UDI-DI
- D0470005981
- 510(k) Number
- FDA product code
- EBI
- GMDN term
- Denture reliner, elastic, short-term
- Device class
- Class II
- Regulation number
- 872.3760
- GUDID distribution status
- Not in Commercial Distribution
Similar devices
Other devices filed under FDA product code EBI (RESIN, DENTURE, RELINING, REPAIRING, REBASING).
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- COMFORT ACRYLICS PLIABLE DENTURE LINERS & SPLINTS by COMFORT ACRYLICS, INC.
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- VERTEX SELF CURING, VERTEX CASTAVARIA, VERTEX CASTAPRESS by Vertex-Dental B.V.
- A-SOFT RELINER by S & C Polymer GmbH
- RESIL by PARKER LABORATORIES, INC.