Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Kerr Corporation (Danbury) — Predicate Candidate Screening
32 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
70 daysmedian FDA review time
133 days90th percentile
32clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K051545 | L.E. DEMETRON II | Kerr Corporation (Danbury) | 2005-07-18 | 38 | 0 |
| K020091 | OPTILUX 501 | Kerr Corporation (Danbury) | 2002-03-21 | 70 | 0 |
| K951663 | TYTIN R | Kerr Corporation (Danbury) | 1995-06-06 | 57 | 1 |
| K951511 | TYTIN ADMIX | Kerr Corporation (Danbury) | 1995-05-02 | 29 | 0 |
| K942480 | M4 CONTRA-ANGLE HANDPIECE | Kerr Corporation (Danbury) | 1995-01-27 | 247 | 0 |
| K940513 | OPTIBOND | Kerr Corporation (Danbury) | 1994-04-15 | 70 | 0 |
| K935535 | TYTIN | Kerr Corporation (Danbury) | 1994-03-11 | 115 | 0 |
| K934690 | KERR OPTIBOND, MODIFICATION | Kerr Corporation (Danbury) | 1993-12-30 | 157 | 0 |
| K923546 | OPTIBOND | Kerr Corporation (Danbury) | 1992-09-29 | 75 | 0 |
| K915847 | AUTOMIX DENTAL AMALGAMATOR | Kerr Corporation (Danbury) | 1992-03-02 | 67 | 0 |
| K904756 | MATRICS | Kerr Corporation (Danbury) | 1991-03-15 | 147 | 0 |
| K904482 | STAT.BR TM | Kerr Corporation (Danbury) | 1990-11-29 | 58 | 0 |
| K894219 | TEMP BOND NE | Kerr Corporation (Danbury) | 1989-09-18 | 91 | 0 |
| K880250 | KERR XR BOND | Kerr Corporation (Danbury) | 1988-06-01 | 133 | 0 |
| K880251 | KERR XR IONOMER | Kerr Corporation (Danbury) | 1988-06-01 | 133 | 0 |
| K880685 | PORCELITE DUAL CURE CEMENT | Kerr Corporation (Danbury) | 1988-05-11 | 82 | 0 |
| K880684 | XR PRIMER | Kerr Corporation (Danbury) | 1988-05-11 | 82 | 0 |
| K872147 | KERR CAVALITE | Kerr Corporation (Danbury) | 1987-08-26 | 83 | 0 |
| K860346 | KERR PORCELITE | Kerr Corporation (Danbury) | 1986-03-25 | 55 | 0 |
| K860532 | KERR POL-E-LASTIC DENTAL IMPRESSION MATERIAL | Kerr Corporation (Danbury) | 1986-03-20 | 36 | 0 |
| K844662 | KERR HERCULITE DENTAL COMPOSITE RESTORATIVE MATERI | Kerr Corporation (Danbury) | 1985-03-25 | 115 | 0 |
| K843023 | KERR PORCELAIN REPAIR PRIMER | Kerr Corporation (Danbury) | 1984-10-25 | 85 | 0 |
| K843025 | COMMAND ENAMEL-DENT DENTAL ADHESIVE | Kerr Corporation (Danbury) | 1984-10-25 | 85 | 0 |
| K843024 | COMMAND ULTRASEAL PIT & FISSURE SEALANT | Kerr Corporation (Danbury) | 1984-09-27 | 57 | 0 |
| K843026 | KERR GELLED PHOSPHORIC ACID ETCHANT | Kerr Corporation (Danbury) | 1984-09-27 | 57 | 0 |
| K843072 | EVER-BOND V GLASS LONOMER RESTORATIVE | Kerr Corporation (Danbury) | 1984-09-07 | 32 | 0 |
| K843022 | KERR COMMAND ULTRAFINE POLISHING PASTE | Kerr Corporation (Danbury) | 1984-08-24 | 23 | 0 |
| K781688 | LINER, CAVITY CALCIUM HYDROXIDE | Kerr Corporation (Danbury) | 1978-12-20 | 77 | 0 |
| K781689 | REFLECT IMPRESSION MATERIAL | Kerr Corporation (Danbury) | 1978-11-15 | 42 | 0 |
| K780712 | KERR DISCOVERY DISPOSABLE FLUORIDE TRAY | Kerr Corporation (Danbury) | 1978-05-17 | 21 | 0 |
| K780213 | HANDPIECE, LIFT, ENDO | Kerr Corporation (Danbury) | 1978-02-17 | 9 | 0 |
| K780211 | 4-IN-1 DISP. CROWN & BRIDGE TRAY | Kerr Corporation (Danbury) | 1978-02-16 | 8 | 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