GC Reline ™ 000602
GC Reline ™ 000602 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 D0470006021), 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 | NumberD0470006021 | 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 D0470006021 listed 1 Aug 2016 Listed
Timeline
- Cleared FDA 510(k) K990736
- Listed FDA GUDID D0470006021
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- Withdrawn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
- 000602
- Primary DI / UDI-DI
- D0470006021
- 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
- Size
- Weight — 12 Gram
Similar devices
Other devices filed under FDA product code EBI (RESIN, DENTURE, RELINING, REPAIRING, REBASING).
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- ORTHO-KEV APPLIANCE REINFORCING SYSTEM by American Orthodontics
- COMFORTSOFT SOFT DENTURE LINER SYSTEM by WHIP-MIX CORP.
- G-CAM GC00293 by GRAPHENANO DENTAL SL.
- ENIGMA HI-BASE DENTURE BASE MATERIAL by Davis Schottlander & Davis Ltd
- MUCOHARD by PARKELL, INC.
- Diamond D 1013091 by Keystone Industries
- LUCITONE FRS FLEXIBEL DENTAL RESIN by Dentsply Intl.