Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dent Zar, Inc. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
74 daysmedian FDA review time
81 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K962277 | SELF CURE BONDING AGENT | Dent Zar, Inc. | 1996-07-03 | 20 | 0 |
| K960599 | SUPERIOR PHOTOCURING HYBRID COMPOSITE | Dent Zar, Inc. | 1996-04-26 | 74 | 0 |
| K960596 | ORION-I CORE BUILD-UP MATERIAL CHEMICAL CURE | Dent Zar, Inc. | 1996-04-26 | 74 | 0 |
| K960729 | ENAMEL CONDITIONER (ENAMEL ETCHING AGENT) | Dent Zar, Inc. | 1996-04-26 | 64 | 0 |
| K960600 | LEXUR ENAMEL COATING-PORCELAIN REPAIR-BONDING VENEERS | Dent Zar, Inc. | 1996-04-26 | 74 | 0 |
| K960598 | CONCORD MARYLAND BRIDGE CEMENT | Dent Zar, Inc. | 1996-04-26 | 74 | 0 |
| K960594 | LIGHT SUPER BOND-1 LIGHT CURED ORTHODONTIC ADHESIVE FOR META | Dent Zar, Inc. | 1996-04-26 | 74 | 0 |
| K960597 | ORION-1 VL CROWN BASE AND POST CEMENT VISIBLE LIGHT CURE | Dent Zar, Inc. | 1996-04-26 | 74 | 0 |
| K960595 | FANTASTIC 1 CONTACT CURE ORTHODONTIC ADHESIVE FOR PLASTIC AN | Dent Zar, Inc. | 1996-04-26 | 74 | 0 |
| K960565 | ACORN ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE | Dent Zar, Inc. | 1996-03-22 | 42 | 0 |
| K894639 | SKYROCK AND LIGHT SUPERBOND | Dent Zar, Inc. | 1989-10-20 | 88 | 0 |
| K891698 | ZAROLAN, DUALAN, TITAN AND SUPERON | Dent Zar, Inc. | 1989-06-09 | 81 | 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