Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
American Medical Ceramics, Inc. · Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
34 daysmedian FDA review time
45 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K901178 | AMALGAM CONDENSER | American Medical Ceramics, Inc. | 1990-04-27 | 45 | 0 |
| K901169 | 5 STRAIGHT SCISSORS | American Medical Ceramics, Inc. | 1990-04-16 | 34 | 0 |
| K901170 | PERIODONTAL KNIFE | American Medical Ceramics, Inc. | 1990-04-16 | 34 | 0 |
| K901171 | U-15 SINGLE END SCALER | American Medical Ceramics, Inc. | 1990-04-16 | 34 | 0 |
| K901172 | GRACEY CURETTE #13-14 | American Medical Ceramics, Inc. | 1990-04-16 | 34 | 0 |
| K901173 | DISCOID SPOON EXCAVATOR | American Medical Ceramics, Inc. | 1990-04-16 | 34 | 0 |
| K901174 | ELEVATOR #11 | American Medical Ceramics, Inc. | 1990-04-16 | 34 | 0 |
| K901175 | HAND MIRROR | American Medical Ceramics, Inc. | 1990-04-16 | 34 | 0 |
| K901176 | #23 EXPLORER | American Medical Ceramics, Inc. | 1990-04-16 | 34 | 0 |
| K901177 | DISCOID/CLEOID DOUBLE END AMALGAM CARVER | American Medical Ceramics, Inc. | 1990-04-16 | 34 | 0 |
| K896843 | EXPLORER 24 DENTAL HAND INSTRUMENT | American Medical Ceramics, Inc. | 1990-03-06 | 90 | 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