510(k) K083344
K083344 is an FDA 510(k) premarket notification submitted by Sirona Dental Systems GmbH for the device "HELIODENT PLUS". The FDA issued a decision of Substantially Equivalent on December 23, 2008. 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 at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 23, 2008
- Date Received
- November 13, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Unit, X-Ray, Extraoral With Timer
- Device Class
- Class II
- Regulation Number
- 872.1800
- Review Panel
- RA
- Submission Type