510(k) K063170
K063170 is an FDA 510(k) premarket notification submitted by Micerium S.P.A. for the device "TENDER FIBER". The FDA issued a decision of Substantially Equivalent on Jan 12, 2007. The device falls under product code EBI (Resin, Denture, Relining, Repairing, Rebasing), a Class II device regulated under 21 CFR 872.3760. Micerium S.P.A. has 5 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 12, 2007
- Date Received
- Oct 18, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Resin, Denture, Relining, Repairing, Rebasing
- Device Class
- Class II
- Regulation Number
- 872.3760
- Review Panel
- DE
- Submission Type
- 510(k)