Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EMN · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
68 daysmedian FDA review time
316 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K070127 | PLAQUE SCRAPER-A INTERPROXIMAL (BETWEEN TEETH) PLAQUE REMOVE | Kevin Vu, Dds | 2007-03-29 | 72 | 0 |
| K931330 | DENTAL INSTRUMENTS SCALER | Minnesota Prophy Power, Inc. | 1994-01-26 | 316 | 0 |
| K851721 | 1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS | Artiberia | 1985-07-02 | 68 | 0 |
| K821786 | BEACH SCALERS | Pacific Dental Corp. | 1982-07-06 | 19 | 0 |
| K781035 | PERIODONTAL INSTRUMENT #21 GOLDMAN-FOX | Premier Dental Products Co. | 1978-06-30 | 11 | 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