510(k) K151045
K151045 is an FDA 510(k) premarket notification submitted by Sirona Dental Systems GmbH for the device "TENEO Dental Treatment Unit and Accessories". The FDA issued a decision of Substantially Equivalent on Jul 24, 2015. The device falls under product code EIA (Unit, Operative Dental), a Class I device regulated under 21 CFR 872.6640. Sirona Dental Systems GmbH has 41 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 24, 2015
- Date Received
- Apr 20, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Unit, Operative Dental
- Device Class
- Class I
- Regulation Number
- 872.6640
- Review Panel
- DE
- Submission Type
- 510(k)