Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Overjet, Inc. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
122 daysmedian FDA review time
260 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261059 | Overjet Multi-Image Caries and Charting Assist | Overjet, Inc. | 2026-08-06 | 128 | 0 |
| K253930 | Overjet Iris Intelligent Imaging System | Overjet, Inc. | 2026-04-10 | 122 | 0 |
| K251514 | Overjet CBCT Assist | Overjet, Inc. | 2025-12-05 | 203 | 0 |
| K241681 | Overjet Image Enhancement Assist | Overjet, Inc. | 2024-09-09 | 90 | 0 |
| K241684 | Overjet Charting Assist | Overjet, Inc. | 2024-08-27 | 77 | 0 |
| K233738 | Overjet Caries Assist-Pediatric | Overjet, Inc. | 2024-03-04 | 103 | 0 |
| K233590 | Overjet Charting Assist | Overjet, Inc. | 2024-02-23 | 107 | 0 |
| K231678 | Overjet Periapical Radiolucency Assist | Overjet, Inc. | 2023-09-21 | 104 | 0 |
| K222746 | Overjet Caries Assist | Overjet, Inc. | 2023-03-27 | 196 | 0 |
| K220928 | Overjet Calculus Assist | Overjet, Inc. | 2022-12-16 | 260 | 0 |
| K212519 | Overjet Caries Assist | Overjet, Inc. | 2022-05-10 | 273 | 0 |
| K210187 | Overjet Dental Assist | Overjet, Inc. | 2021-05-19 | 114 | 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