Gc Reline Soft/Extra Soft
510(k) K990736
Gc Reline Soft/Extra Soft is a Class II device made by Gc America Inc., cleared under FDA 510(k) K990736 on 28 May 1999, 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 | FDA 510(k)SESE | NumberK990736 | Date28 May 1999 | StatusActive |
Official records
- FDA 510(k) database K990736
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EBI
- FDA applicant
- GC America, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3760
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K990736
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| GC Reline ™ 000598 | 000598 / 000598 | D0470005981 | — | No longer on the market |
| GC Reline ™ 000599 | 000599 / 000599 | D0470005991 | Weight 62 g | No longer on the market |
| GC Reline ™ 000600 | 000600 / 000600 | D0470006001 | — | No longer on the market |
| GC Reline ™ 000601 | 000601 / 000601 | D0470006011 | Weight 56 g | No longer on the market |
| GC Reline ™ 000602 | 000602 / 000602 | D0470006021 | Weight 12 g | No longer on the market |
| GC Reline ™ 000603 | 000603 / 000603 | D0470006031 | — | No longer on the market |
| GC Reline ™ 001859 | 001859 / 001859 | D0470018591 | Weight 56 g | No longer on the market |
| GC Reline™ 001525 | 001525 / 001525 | D0470015251 | — | No longer on the market |
| GC Reline™ 001526 | 001526 / 001526 | D0470015261 | — | No longer on the market |
Similar devices
Other devices filed under FDA product code EBI (Resin, Denture, Relining, Repairing, Rebasing).
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