Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
EBO · Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
119 daysmedian FDA review time
212 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K850927 | COMPLETE DENTURE REPAIR KIT | Tooth Aid Lab, Inc. | 1985-07-02 | 119 | 0 |
| K844480 | DENTAL ORAL CARE SYSTEMS & COMPONENTS | Advanced Bio Systems, Inc. | 1985-06-19 | 212 | 0 |
| K833056 | UNIVERSAL LINE-A-PLATE | Laurentian Laboratories | 1984-02-27 | 173 | 0 |
| K833057 | UNIVERSAL FIX-A-PLATE | Laurentian Laboratories | 1984-02-27 | 173 | 0 |
| K820245 | SAFE TDENT | Professional Dental Studios | 1982-04-09 | 70 | 0 |
| K820685 | DENTURE ADJUSTMENT KIT | Camdent Laboratories | 1982-04-09 | 29 | 0 |
| K770091 | EMERGENCY FAST-FIX DENTURE REPAIR KIT | Mr. Clarence Hurst | 1977-01-24 | 7 | 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