510(k) K062906
K062906 is an FDA 510(k) premarket notification submitted by Micerium S.P.A. for the device "ENA HFO COMPOSITE SYSTEM". The FDA issued a decision of Substantially Equivalent on Nov 17, 2006. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. Micerium S.P.A. has 5 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 17, 2006
- Date Received
- Sep 27, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Material, Tooth Shade, Resin
- Device Class
- Class II
- Regulation Number
- 872.3690
- Review Panel
- DE
- Submission Type
- 510(k)