510(k) K072978
K072978 is an FDA 510(k) premarket notification submitted by Micerium S.P.A. for the device "TENDER ORTHO BOND-ENA BOND-ENA ETCH". The FDA issued a decision of Substantially Equivalent on Jan 17, 2008. The device falls under product code DYH (Adhesive, Bracket And Tooth Conditioner, Resin), a Class II device regulated under 21 CFR 872.3750. Micerium S.P.A. has 5 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 17, 2008
- Date Received
- Oct 22, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Adhesive, Bracket And Tooth Conditioner, Resin
- Device Class
- Class II
- Regulation Number
- 872.3750
- Review Panel
- DE
- Submission Type
- 510(k)