510(k) K190234
K190234 is an FDA 510(k) premarket notification submitted by Cnd Global Technologies, Inc. for the device "ODI HD Dental Sensor". The FDA issued a decision of Substantially Equivalent on Mar 1, 2019. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 1, 2019
- Date Received
- Feb 6, 2019
- 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
- 510(k)