510(k) K122269
K122269 is an FDA 510(k) premarket notification submitted by Vita Zahnfabrik H.Rauter GmbH & Co. for the device "ENAMIC". The FDA issued a decision of Substantially Equivalent on Dec 13, 2012. 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. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 13, 2012
- Date Received
- Jul 30, 2012
- Clearance Type
- Abbreviated
- 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