Overjet, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Overjet, Inc.” (first 2021, latest 2026), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 118 days. Since 2017 the median was 118 days, against 133 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2021 | 1 | 114 |
| 2022 | 2 | 266 |
| 2023 | 2 | 150 |
| 2024 | 4 | 96 |
| 2025 | 1 | 203 |
| 2026 | 2 | 125 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Overjet, Inc. took a median 118 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 133 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MYN | Analyzer, Medical Image | 6 | 6 |
| QIH | Automated Radiological Image Processing Software | 5 | 5 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
Review panels
- Radiology (12)
Most recent Overjet, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261059 | Overjet Multi-Image Caries and Charting Assist | MYN | 2026-08-06 | 128 |
| K253930 | Overjet Iris Intelligent Imaging System | QIH | 2026-04-10 | 122 |
| K251514 | Overjet CBCT Assist | QIH | 2025-12-05 | 203 |
| K241681 | Overjet Image Enhancement Assist | QIH | 2024-09-09 | 90 |
| K241684 | Overjet Charting Assist | QIH | 2024-08-27 | 77 |
| K233738 | Overjet Caries Assist-Pediatric | MYN | 2024-03-04 | 103 |
| K233590 | Overjet Charting Assist | QIH | 2024-02-23 | 107 |
| K231678 | Overjet Periapical Radiolucency Assist | MYN | 2023-09-21 | 104 |
| K222746 | Overjet Caries Assist | MYN | 2023-03-27 | 196 |
| K220928 | Overjet Calculus Assist | MYN | 2022-12-16 | 260 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Overjet, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Overjet, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Overjet, Inc.” (first 2021, latest 2026), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Overjet, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Overjet, Inc. is 118 days. Since 2017: 118 days, versus 133 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Overjet, Inc.?
The most frequent FDA product codes under this applicant name are MYN (Analyzer, Medical Image, 6); QIH (Automated Radiological Image Processing Software, 5); LLZ (System, Image Processing, Radiological, 1).
Next steps
- See all 12 Overjet, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MYN, Overjet, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.