510(k) K013650
K013650 is an FDA 510(k) premarket notification submitted by Sirona Dental Systems GmbH for the device "ORTHOPHOS DS/DC CEPH, ORTHOPHOS 5/PLUS/CD". The FDA issued a decision of Substantially Equivalent on Dec 6, 2001. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Sirona Dental Systems GmbH has 41 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 6, 2001
- Date Received
- Nov 6, 2001
- 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
- 510(k)