GC America, Inc.: FDA filings under this applicant name
FDA lists 129 510(k) clearances under the applicant name “GC America, Inc.” (first 1993, latest 2026), across 18 product codes in 1 review panel. Median 510(k) review time under this name: 78 days. Since 2017 the median was 186 days, against 156 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 116 |
| 2013 | 2 | 321 |
| 2014 | 4 | 86 |
| 2015 | 2 | 146 |
| 2016 | 7 | 236 |
| 2017 | 0 | — |
| 2018 | 4 | 170 |
| 2019 | 2 | 184 |
| 2020 | 5 | 240 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 3 | 174 |
| 2026 | 4 | 112 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name GC America, Inc. took a median 186 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 156 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EMA | Cement, Dental | 30 | 30 |
| EBF | Material, Tooth Shade, Resin | 24 | 24 |
| ELW | Material, Impression | 15 | 15 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 12 | 12 |
| KLE | Agent, Tooth Bonding, Resin | 11 | 11 |
| EIH | Powder, Porcelain | 8 | 8 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 6 | 6 |
| EBG | Crown And Bridge, Temporary, Resin | 6 | 6 |
| NHA | Abutment, Implant, Dental, Endosseous | 3 | 3 |
| DZE | Implant, Endosseous, Root-Form | 2 | 2 |
Plus 8 more product codes.
Review panels
- Dental (129)
Most recent GC America, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262202 | Cerasmart Forte | EBF | 2026-09-10 | 73 |
| K253317 | Cytrans Elashield | LYC | 2026-07-06 | 279 |
| K261246 | SRGC-06 | EBF | 2026-06-18 | 63 |
| K254109 | G-CEM UNIVERSAL | EMA | 2026-05-18 | 150 |
| K251124 | G-Bond Universal | KLE | 2025-10-02 | 174 |
| K250953 | EQUIA LC ONE | EMA | 2025-09-19 | 175 |
| K251946 | G aenial Universal Injectable II | EBF | 2025-08-29 | 65 |
| K200798 | G-CEM ONE | EMA | 2020-11-24 | 243 |
| K200682 | BZF-29 | KLE | 2020-10-02 | 200 |
| K192597 | Cytrans Granules | LYC | 2020-08-17 | 332 |
119 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named GC America, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under GC America, Inc.?
FDA lists 129 510(k) clearances under the applicant name “GC America, Inc.” (first 1993, latest 2026), across 18 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by GC America, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name GC America, Inc. is 78 days. Since 2017: 186 days, versus 156 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under GC America, Inc.?
The most frequent FDA product codes under this applicant name are EMA (Cement, Dental, 30); EBF (Material, Tooth Shade, Resin, 24); ELW (Material, Impression, 15).
Next steps
- See all 129 GC America, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EMA, GC America, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.