Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pentron Ceramics, Inc. · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K081749 | AVANTE Z ZIRCONIA (AS)3 BLOCKS | Pentron Ceramics, Inc. | 2008-09-30 | 103 | 0 |
| K070699 | AVANTE Z; PELLET, PRESSABLE STAIN, ADD-ON PORCELAIN, PORCELA | Pentron Ceramics, Inc. | 2007-06-29 | 108 | 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