Overjet
Boston, MA, US
OVERJET appears in FDA device records in Boston, MA. FDA records list 12 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 12 510(k) clearances for Overjet between 2021 and 2026. The busiest year on record is 2024, with 4. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2021 | 1 |
| 2022 | 2 |
| 2023 | 2 |
| 2024 | 4 |
| 2025 | 1 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261059 | Overjet Multi-Image Caries and Charting Assist | MYN | Substantially Equivalent | |
| K253930 | Overjet Iris Intelligent Imaging System | QIH | Substantially Equivalent | |
| K251514 | Overjet CBCT Assist | QIH | Substantially Equivalent | |
| K241681 | Overjet Image Enhancement Assist | QIH | Substantially Equivalent | |
| K241684 | Overjet Charting Assist | QIH | Substantially Equivalent | |
| K233738 | Overjet Caries Assist-Pediatric | MYN | Substantially Equivalent | |
| K233590 | Overjet Charting Assist | QIH | Substantially Equivalent | |
| K231678 | Overjet Periapical Radiolucency Assist | MYN | Substantially Equivalent | |
| K222746 | Overjet Caries Assist | MYN | Substantially Equivalent | |
| K220928 | Overjet Calculus Assist | MYN | Substantially Equivalent | |
| K212519 | Overjet Caries Assist | MYN | Substantially Equivalent | |
| K210187 | Overjet Dental Assist | LLZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3019544554 | 3019544554 | OVERJET | 200 State St Ste 1220, Boston, MA 02109 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain