G-C Intl. Corp.: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “G-C Intl. Corp.” (first 1981, latest 1991), across 11 product codes in 2 review panels. Median 510(k) review time under this name: 55 days. 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EMA | Cement, Dental | 7 | 7 |
| ELW | Material, Impression | 4 | 4 |
| EBF | Material, Tooth Shade, Resin | 2 | 2 |
| EJJ | Alloy, Amalgam | 2 | 2 |
| ELL | Teeth, Porcelain | 2 | 2 |
| EBG | Crown And Bridge, Temporary, Resin | 1 | 1 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 1 | 1 |
| EGW | Dryer, Film, Radiographic | 1 | 1 |
| EID | Syringe, Restorative And Impression Material | 1 | 1 |
| EJK | Liner, Cavity, Calcium Hydroxide | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent G-C Intl. Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K913175 | MIRACLE MIX CAPS GLASS IONOMER CEMENT INCAPSULES | EJJ | 1991-12-27 | 163 |
| K913884 | FUJI II LC | EMA | 1991-10-30 | 62 |
| K901999 | FUJI LINING CEMENT LIGHT CURE | EJK | 1990-07-31 | 90 |
| K902531 | EXAPHASE, SINGLE PHASE IMPRESSION MATERIAL | EGW | 1990-07-13 | 38 |
| K896883 | GC CERVICAL CEMENT | EMA | 1990-07-06 | 210 |
| K895976 | TOOTH SHADE RESIN | EBF | 1989-12-22 | 71 |
| K892806 | TUF-COAT | ELL | 1989-07-14 | 88 |
| K890830 | DENTURE RESIN | EBI | 1989-05-01 | 69 |
| K890829 | UNIFAST LC | EBG | 1989-04-17 | 55 |
| K883770 | RESUBMITTED EMA DENTIN CEMENT | EMA | 1988-11-30 | 85 |
13 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named G-C Intl. Corp..
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 G-C Intl. Corp.?
FDA lists 23 510(k) clearances under the applicant name “G-C Intl. Corp.” (first 1981, latest 1991), across 11 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by G-C Intl. Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name G-C Intl. Corp. is 55 days.
Which FDA product codes appear under G-C Intl. Corp.?
The most frequent FDA product codes under this applicant name are EMA (Cement, Dental, 7); ELW (Material, Impression, 4); EBF (Material, Tooth Shade, Resin, 2).
Next steps
- See all 23 G-C Intl. Corp. clearances with predicates and recalls
- Run predicate analysis for product code EMA, G-C Intl. Corp.'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.