510(k) K093446
K093446 is an FDA 510(k) premarket notification submitted by Vita Zahnfabrik H. Rauter GmbH & Co. Kg. for the device "VITA VMK MASTER". The FDA issued a decision of Substantially Equivalent on December 3, 2009. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660. Vita Zahnfabrik H. Rauter GmbH & Co. Kg. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 3, 2009
- Date Received
- November 5, 2009
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Powder, Porcelain
- Device Class
- Class II
- Regulation Number
- 872.6660
- Review Panel
- DE
- Submission Type