Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
EID — Predicate Candidate Screening
13 FDA 510(k) clearances under this product code; the 50 most recent screened below.
20 daysmedian FDA review time
110 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K941431 | BONE GRAFT DELIVERY SYRINGES | Bio-Interfaces, Inc. | 1994-07-12 | 110 | 0 |
| K913974 | ACCESS IMPRESSION BARREL | Centrix, Inc. | 1992-02-25 | 172 | 0 |
| K873153 | CAULK'S VPS CARTRIDGE SYSTEM | Dentsply Intl. | 1987-09-16 | 36 | 0 |
| K871937 | IMPRESSION SYRINGE | Dentsply Intl. | 1987-06-05 | 18 | 0 |
| K863998 | COLTENE JET-MIXER | Coltene, Inc. | 1986-10-30 | 16 | 0 |
| K853282 | CENTRIX RIBBON TUBES | Centrix, Inc. | 1985-08-23 | 18 | 0 |
| K851386 | UNITEK DISPOSABLE IMPRESSION SYRINGE | Unitek Corp. | 1985-04-29 | 20 | 0 |
| K812680 | G-C IMPRESSION SYRINGE | G-C Intl. Corp. | 1981-10-06 | 14 | 0 |
| K812277 | PRISMA-FIL COMPULES | Caulk Co., Div. Dentsply | 1981-09-08 | 26 | 0 |
| K811582 | THE PLACER | Cavitron Corp. | 1981-07-28 | 53 | 0 |
| K781977 | APPLICATOR, LEE IMPRESSION | Lee Pharmaceuticals | 1978-12-20 | 23 | 0 |
| K770931 | APPLIC SYSTEM APPLIER, ESPE | Espe GmbH (Us) | 1977-06-03 | 11 | 0 |
| K770941 | APPLIC SYSTEM ACTIVATOR, ESPE | Espe GmbH (Us) | 1977-06-02 | 10 | 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