510(k) K133231
K133231 is an FDA 510(k) premarket notification submitted by Instrumentarium Dental, Palodex Group OY for the device "DIGORA OPTIME". The FDA issued a decision of Substantially Equivalent on March 20, 2014. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Instrumentarium Dental, Palodex Group OY has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 20, 2014
- Date Received
- October 21, 2013
- Clearance Type
- Special
- 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