510(k) K101661
K101661 is an FDA 510(k) premarket notification submitted by Cefla Dental Group for the device "MYRAY HYPERION". The FDA issued a decision of Substantially Equivalent on September 16, 2010. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Cefla Dental Group has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 16, 2010
- Date Received
- June 14, 2010
- 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