Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Pulpdent Corp. of America · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
70 daysmedian FDA review time
347 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K882576 | ACID ETCH GEL | Pulpdent Corp. of America | 1988-07-15 | 23 | 0 |
| K863834 | EVIDENT MARK 2 APEX LOCATOR | Pulpdent Corp. of America | 1987-02-06 | 129 | 0 |
| K854977 | FIBER MESH | Pulpdent Corp. of America | 1986-02-20 | 70 | 0 |
| K844446 | BISICO SL(PUTTY) BISICO S2(REGULAR) S3 HEAVY ETC. | Pulpdent Corp. of America | 1985-10-29 | 347 | 0 |
| K853447 | POLYCARB WATER SET | Pulpdent Corp. of America | 1985-10-16 | 61 | 0 |
| K810545 | PCA PERIOCARE PERIODONTAL DRESSING | Pulpdent Corp. of America | 1981-03-24 | 25 | 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