510(k) K172918
K172918 is an FDA 510(k) premarket notification submitted by Kavo Dental Technologies, LLC for the device "DEXIS Titanium, KaVo IXS HD (Size 1, Size 2)". The FDA issued a decision of Substantially Equivalent on December 18, 2017. 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
- December 18, 2017
- Date Received
- September 25, 2017
- 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