FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Overjet Calculus Assist
K Number: K220928
·
Decision Dec 16, 2022
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
36
Applicant Total
11
Review Days
260
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Overjet Calculus Assist
- K Number
- K220928
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2070
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Overjet, Inc.
- Date Received
- March 31, 2022
- Decision Date
- December 16, 2022
- Product Code
- MYN
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MYN | Analyzer, Medical Image | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MYN), ordered by most recent decision date.
Velmeni for Dentists (V4D) Endo-Perio
FDA 510(k)
FDA Class 2
·Radiology
qXR-Detect
FDA 510(k)
FDA Class 2
·Radiology
Diagnocat
FDA 510(k)
FDA Class 2
·Radiology
DS Core Detect
FDA 510(k)
FDA Class 2
·Radiology
DTX Studio Assist
FDA 510(k)
FDA Class 2
·Radiology
Second Opinion® Panoramic
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Overjet, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253930 | Overjet Iris Intelligent Imaging System | Apr 10, 2026 | Substantially Equivalent |
| K251514 | Overjet CBCT Assist | Dec 5, 2025 | Substantially Equivalent |
| K241681 | Overjet Image Enhancement Assist | Sep 9, 2024 | Substantially Equivalent |
| K241684 | Overjet Charting Assist | Aug 27, 2024 | Substantially Equivalent |
| K233738 | Overjet Caries Assist-Pediatric | Mar 4, 2024 | Substantially Equivalent |
| K233590 | Overjet Charting Assist | Feb 23, 2024 | Substantially Equivalent |
| K231678 | Overjet Periapical Radiolucency Assist | Sep 21, 2023 | Substantially Equivalent |
| K222746 | Overjet Caries Assist | Mar 27, 2023 | Substantially Equivalent |
| K212519 | Overjet Caries Assist | May 10, 2022 | Substantially Equivalent |
| K210187 | Overjet Dental Assist | May 19, 2021 | Substantially Equivalent |