510(k) K233053
DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor by
Dental Imaging Technologies Corporation
— Product Code MUH
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 21, 2023
- Date Received
- September 25, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Extraoral Source, Digital
- Device Class
- Class II
- Regulation Number
- 872.1800
- Review Panel
- RA
- Submission Type