510(k) K961434
K961434 is an FDA 510(k) premarket notification submitted by Vident for the device "VITA ZETA CROWN AND BRIDGE ACRYLIC VENEERING SYSTEM". The FDA issued a decision of Substantially Equivalent on Jul 8, 1996. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. Vident has 35 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 8, 1996
- Date Received
- Apr 15, 1996
- 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)