510(k) K033073
K033073 is an FDA 510(k) premarket notification submitted by Sirona Dental Systems GmbH for the device "ORTHOPHOS XG DS/CEPH". The FDA issued a decision of Substantially Equivalent on Oct 10, 2003. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), 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
- Oct 10, 2003
- Date Received
- Sep 29, 2003
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Unit, X-Ray, Extraoral With Timer
- Device Class
- Class II
- Regulation Number
- 872.1800
- Review Panel
- RA
- Submission Type
- 510(k)