FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OpenSensorX Series
K Number: K220556
·
Decision Apr 13, 2022
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
205
Applicant Total
2
Review Days
44
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Basic Information
- Device Name
- OpenSensorX Series
- K Number
- K220556
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.1800
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dentimax, Inc.
- Date Received
- February 28, 2022
- Decision Date
- April 13, 2022
- Product Code
- MUH
- Advisory Committee
- Dental
- 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 |
|---|---|---|---|
| MUH | System, X-Ray, Extraoral Source, Digital | FDA class 2 | Dental |
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Other Clearances by Dentimax, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251206 | Digital X-Ray DentiMax Pro Imaging System | Sep 24, 2025 | Substantially Equivalent |