Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
EMS · Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
65 daysmedian FDA review time
317 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K931329 | DENTAL INSTRUMENTS CURETTE PERIODONTAL | Minnesota Prophy Power, Inc. | 1994-01-27 | 317 | 0 |
| K872091 | CURRETTES, ALVEOLAR (MOLT AND MILLER) | Military Engineering, Inc. | 1987-07-31 | 60 | 0 |
| K870590 | CURETTE, PERIODONTAL, COLUMBIA UNIVERSITY | Military Engineering, Inc. | 1987-04-16 | 65 | 0 |
| K841011 | ELEVATOR - VARIOUS | Premier Dental Products Co. | 1984-06-15 | 98 | 0 |
| K834072 | INSTRUMENT, DENTAL | Venture Technology, Inc. | 1984-02-21 | 88 | 0 |
| K823319 | DENTAL INSTRUMENTS - SCALERS | Miltex, Inc. | 1982-11-24 | 16 | 0 |
| K821789 | BEACH CURETTE NO. 2 AND NO. 3 T.G. | Pacific Dental Corp. | 1982-07-06 | 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