GC America, Inc.
FDA 510(k) & PMA Approved Devices — 24 products
Total Devices24
Categories8
Latest FDA decision2026-07-06
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K253317 | Cytrans™ Elashield | LYC | 2026-07-06 | View |
| 510(k) | K261246 | SRGC-06 | EBF | 2026-06-18 | View |
| 510(k) | K254109 | G-CEM UNIVERSAL | EMA | 2026-05-18 | View |
| 510(k) | K251124 | G-Bond Universal | KLE | 2025-10-02 | View |
| 510(k) | K250953 | EQUIA LC ONE | EMA | 2025-09-19 | View |
| 510(k) | K251946 | G aenial Universal Injectable II | EBF | 2025-08-29 | View |
| 510(k) | K200798 | G-CEM ONE | EMA | 2020-11-24 | View |
| 510(k) | K200682 | BZF-29 | KLE | 2020-10-02 | View |
| 510(k) | K192597 | Cytrans Granules | LYC | 2020-08-17 | View |
| 510(k) | K193113 | GC Temp Print | EBG | 2020-07-09 | View |
| 510(k) | K193484 | GC Fuji Triage EP | EMA | 2020-07-02 | View |
| 510(k) | K192260 | everX Flow | EBF | 2019-11-22 | View |
| 510(k) | K182854 | GC FujiCEM 2 (Improved) | EMA | 2019-07-11 | View |
| 510(k) | K180917 | GC Acrylic Primer | KLE | 2018-11-20 | View |
| 510(k) | K181011 | AIM2 | ELW | 2018-07-12 | View |
| 510(k) | K172382 | GC Fuji Direct | EMA | 2018-04-02 | View |
| 510(k) | K173500 | NMF004A | EBF | 2018-03-08 | View |
| 510(k) | K153130 | Initial LiSi Block | EIH | 2016-09-13 | View |
| 510(k) | K153325 | Gradia Plus | EBF | 2016-07-12 | View |
| 510(k) | K153231 | G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer | EMA | 2016-07-06 | View |
No matching devices.
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