Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
G-C Intl. Corp. — Predicate Candidate Screening
23 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
55 daysmedian FDA review time
116 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K913175 | MIRACLE MIX CAPS GLASS IONOMER CEMENT INCAPSULES | G-C Intl. Corp. | 1991-12-27 | 163 | 0 |
| K913884 | FUJI II LC | G-C Intl. Corp. | 1991-10-30 | 62 | 0 |
| K901999 | FUJI LINING CEMENT LIGHT CURE | G-C Intl. Corp. | 1990-07-31 | 90 | 0 |
| K902531 | EXAPHASE, SINGLE PHASE IMPRESSION MATERIAL | G-C Intl. Corp. | 1990-07-13 | 38 | 0 |
| K896883 | GC CERVICAL CEMENT | G-C Intl. Corp. | 1990-07-06 | 210 | 0 |
| K895976 | TOOTH SHADE RESIN | G-C Intl. Corp. | 1989-12-22 | 71 | 0 |
| K892806 | TUF-COAT | G-C Intl. Corp. | 1989-07-14 | 88 | 0 |
| K890830 | DENTURE RESIN | G-C Intl. Corp. | 1989-05-01 | 69 | 0 |
| K890829 | UNIFAST LC | G-C Intl. Corp. | 1989-04-17 | 55 | 0 |
| K883770 | RESUBMITTED EMA DENTIN CEMENT | G-C Intl. Corp. | 1988-11-30 | 85 | 0 |
| K880848 | FUJI CAP II CAPSULE & APPLIER | G-C Intl. Corp. | 1988-05-16 | 76 | 0 |
| K880849 | EXAMIX DISPENSER | G-C Intl. Corp. | 1988-05-11 | 71 | 0 |
| K880765 | G-CERA PORCELAIN BOND | G-C Intl. Corp. | 1988-04-18 | 52 | 0 |
| K880764 | G-CERA PORCELAIN & G-CERA PORCELAIN MODIFIER | G-C Intl. Corp. | 1988-04-12 | 46 | 0 |
| K851469 | 76 ELW BITE CHECKER SILICONE | G-C Intl. Corp. | 1985-05-01 | 15 | 0 |
| K851468 | 76 EMA LINING CEMENT | G-C Intl. Corp. | 1985-05-01 | 15 | 0 |
| K844653 | LIMI ALLOY | G-C Intl. Corp. | 1985-03-25 | 116 | 0 |
| K844329 | SURFLEX F | G-C Intl. Corp. | 1984-12-03 | 26 | 0 |
| K812680 | G-C IMPRESSION SYRINGE | G-C Intl. Corp. | 1981-10-06 | 14 | 0 |
| K812406 | EXAFLEX IMPRESSION MATERIAL | G-C Intl. Corp. | 1981-10-06 | 46 | 0 |
| K812679 | G-C FIT-CHECKER IMPRESSION MATERIAL | G-C Intl. Corp. | 1981-10-06 | 14 | 0 |
| K812568 | CAVITRON | G-C Intl. Corp. | 1981-09-25 | 16 | 0 |
| K811521 | FUJI IONOMER TYPE I & II | G-C Intl. Corp. | 1981-06-26 | 28 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda