Overjet Calculus Assist
FDA 510(k) K220928 · Overjet, Inc.
510(k) numberK220928
Submission
- Device name
- Overjet Calculus Assist
- Applicant
- Overjet, Inc.
Boston, MA, US - Received
- March 31, 2022
- Decision date
- December 16, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MYN – Analyzer, Medical Image
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.2070
- Specialty
- Radiology
For information on the MYN device, please see: https://www.federalregister.gov/documents/2020/01/22/2020-00494/radiology-devices-reclassification-of-medical-image-analyzers
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| K252486 | ChestView US (1.1)MYN · Traditional | Gleamer | 09/09/2026SE |
| K261059 | Overjet Multi-Image Caries and Charting AssistMYN · Traditional | Overjet, Inc. | 08/06/2026SE |
| K260851 | Better Diagnostics Dental Assist (BDDA) Version 1.0MYN · Traditional | Better Diagnostics AI Corp. | 07/15/2026SE |
| K252953 | Velmeni for Dentists (V4D) Endo-PerioMYN · Traditional | Velmeni, Inc. | 05/11/2026SE |
| K251934 | qXR-DetectMYN · Traditional | Qure.Ai Technologies | 01/16/2026SE |
| K252934 | DiagnocatMYN · Traditional | Dgnct, LLC | 01/15/2026SE |
| K253009 | DS Core DetectMYN · Traditional | Dentsply Sirona, Inc. | 01/07/2026SE |
| K252086 | DTX Studio AssistMYN · Traditional | Nobel Biocare C/O Medicim NV | 11/17/2025SE |
| K250525 | Second Opinion® PanoramicMYN · Traditional | Pearl, Inc. | 11/14/2025SE |
| K250264 | SugarBug (1.x)MYN · Traditional | Bench7, Inc. | 11/07/2025SE |
More from Bench7, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261059 | Overjet Multi-Image Caries and Charting AssistMYN · Traditional | 08/06/2026SE |
| K253930 | Overjet Iris Intelligent Imaging SystemQIH · Traditional | 04/10/2026SE |
| K251514 | Overjet CBCT AssistQIH · Traditional | 12/05/2025SE |
| K241681 | Overjet Image Enhancement AssistQIH · Traditional | 09/09/2024SE |
| K241684 | Overjet Charting AssistQIH · Traditional | 08/27/2024SE |
| K233738 | Overjet Caries Assist-PediatricMYN · Traditional | 03/04/2024SE |
| K233590 | Overjet Charting AssistQIH · Traditional | 02/23/2024SE |
| K231678 | Overjet Periapical Radiolucency AssistMYN · Traditional | 09/21/2023SE |
| K222746 | Overjet Caries AssistMYN · Traditional | 03/27/2023SE |
| K212519 | Overjet Caries AssistMYN · Traditional | 05/10/2022SE |
Questions and answers
When was Overjet Calculus Assist cleared by the FDA?
Overjet Calculus Assist (K220928) received a 510(k) decision of Substantially Equivalent on December 16, 2022, 260 days after the submission was received.
What is the product code of K220928?
The FDA product code is MYN – Analyzer, Medical Image, a Class II (moderate risk) device regulated under 21 CFR 892.2070.