Linkmax
510(k) K001823
Linkmax is a Class II device made by Gc America Inc., cleared under FDA 510(k) K001823 on 16 Aug 2000, 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 | NumberK001823 | Date16 Aug 2000 | StatusActive |
Official records
- FDA 510(k) database K001823
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EMA
- FDA applicant
- GC America, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3275
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K001823
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 CERAMIC PRIMER II 008551 | 008551 / 008551 | 14548161282611 | On the market | |
| GC CERAMIC PRIMER II 008551 | 008551 / 008551 | D0470085511 | On the market | |
| GC CERAMIC PRIMER II 008620 | 008620 / 008620 | D0470086201 | On the market | |
| GC CERAMIC PRIMER II 008620 | 008620 / 008620 | 14548161297301 | On the market |
Similar devices
Other devices filed under FDA product code EMA (Cement, Dental).
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- PREVISION CHEM by Heraeus Kulzer, Inc.
- POLYCARBOXYLATE (PCA) CEMENT by Rite-Dent Manufacturing Corp.