Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Den-Tal-Ez Mfg Co., Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
70 daysmedian FDA review time
382 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K925629 | ACCESSORY TO IMPROVED DENTAL OPERATING LIGHT | Den-Tal-Ez Mfg Co., Inc. | 1993-11-23 | 382 | 0 |
| K932824 | EVACUATOR, ORAL CAVITY | Den-Tal-Ez Mfg Co., Inc. | 1993-09-28 | 111 | 0 |
| K931204 | AS3000 OPERATIVE DENTAL UNIT (DELIVERY SYSTEM) | Den-Tal-Ez Mfg Co., Inc. | 1993-07-08 | 121 | 0 |
| K920017 | IMPROVED DENTAL OPERATING LIGHT | Den-Tal-Ez Mfg Co., Inc. | 1992-03-02 | 60 | 0 |
| K920016 | IMPROVED DENTAL CHAIR | Den-Tal-Ez Mfg Co., Inc. | 1992-03-02 | 60 | 0 |
| K874294 | AUTOCHUCK ATTACHMENT | Den-Tal-Ez Mfg Co., Inc. | 1987-12-29 | 70 | 0 |
| K780469 | PANORAMIC X-RAY, DENTAL | Den-Tal-Ez Mfg Co., Inc. | 1978-04-10 | 19 | 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