510(k) K130991
K130991 is an FDA 510(k) premarket notification submitted by Sagemax Bioceramics, Inc. for the device "NEXXZR(TM)T AND NEXXZR(TM)S". The FDA issued a decision of Substantially Equivalent on February 10, 2014. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660. Sagemax Bioceramics, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 10, 2014
- Date Received
- April 10, 2013
- Clearance Type
- Traditional
- 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