510(k) K081903
K081903 is an FDA 510(k) premarket notification submitted by Sirona Dental Systems GmbH for the device "XIOS PLUS WALL-MODULE". The FDA issued a decision of Substantially Equivalent on August 26, 2008. 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 at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 26, 2008
- Date Received
- July 3, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, X-Ray, Extraoral Source, Digital
- Device Class
- Class II
- Regulation Number
- 872.1800
- Review Panel
- RA
- Submission Type