GC America, Inc.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 125
- Inspections
- 7
- Compliance Actions
- 1
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K251124 | G-Bond Universal | October 2, 2025 |
| K250953 | EQUIA LC ONE | September 19, 2025 |
| K251946 | G aenial Universal Injectable II | August 29, 2025 |
| K200798 | G-CEM ONE | November 24, 2020 |
| K200682 | BZF-29 | October 2, 2020 |
| K192597 | Cytrans Granules | August 17, 2020 |
| K193113 | GC Temp Print | July 9, 2020 |
| K193484 | GC Fuji Triage EP | July 2, 2020 |
| K192260 | everX Flow | November 22, 2019 |
| K182854 | GC FujiCEM 2 (Improved) | July 11, 2019 |
| K180917 | GC Acrylic Primer | November 20, 2018 |
| K181011 | AIM2 | July 12, 2018 |
| K172382 | GC Fuji Direct | April 2, 2018 |
| K173500 | NMF004A | March 8, 2018 |
| K153130 | Initial LiSi Block | September 13, 2016 |
| K153325 | Gradia Plus | July 12, 2016 |
| K153231 | G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer | July 6, 2016 |
| K153136 | Initial LiSi Press | June 30, 2016 |
| K153127 | everX Posterior | May 20, 2016 |
| K152274 | MSCB-001 | March 25, 2016 |