Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pentron Corp. — Predicate Candidate Screening
15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
57 daysmedian FDA review time
92 days90th percentile
15clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K021457 | FLEX SPAN TEMPORARY CROWN & BRIDGE MATERIAL | Pentron Corp. | 2002-08-01 | 87 | 1 |
| K874189 | DUAL-CURE RADIOPAQUE | Pentron Corp. | 1988-02-11 | 120 | 5 |
| K874275 | OPTEC SUPPLEMENTARY KIT | Pentron Corp. | 1988-01-19 | 91 | 0 |
| K874162 | OPTEC STAIN CHARACTERIZATION AND MODIFICATION KIT | Pentron Corp. | 1988-01-12 | 91 | 0 |
| K873683 | CODE #23 R SYSTEM (DENTIN ADHESIVE MATERIAL) | Pentron Corp. | 1987-11-16 | 63 | 0 |
| K873878 | #24L SYSTEM | Pentron Corp. | 1987-10-27 | 35 | 0 |
| K864404 | PENTRON HIGH STRENGTH PORCELAIN | Pentron Corp. | 1986-11-24 | 14 | 0 |
| K854803 | CHAMELEON BONDING KIT | Pentron Corp. | 1986-03-04 | 92 | 0 |
| K844057 | C-22 PIT & FISSURE SEALANT | Pentron Corp. | 1984-12-03 | 46 | 0 |
| K841269 | C-19 | Pentron Corp. | 1984-05-22 | 57 | 0 |
| K841457 | NUMBER 21 R/R SYSTEM | Pentron Corp. | 1984-05-22 | 43 | 0 |
| K841458 | NUMBER 20 R/L SYSTEM | Pentron Corp. | 1984-05-22 | 43 | 0 |
| K841268 | C-17 | Pentron Corp. | 1984-05-22 | 57 | 0 |
| K841267 | C-18 | Pentron Corp. | 1984-04-30 | 35 | 0 |
| K840727 | PENTRA-FIL II | Pentron Corp. | 1984-04-13 | 52 | 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