510(k) K160918
K160918 is an FDA 510(k) premarket notification submitted by Juvora for the device "JUVORA Dental Disc, Ceramill PEEK by JUVORA". The FDA issued a decision of Substantially Equivalent on Feb 13, 2017. The device falls under product code EBI (Resin, Denture, Relining, Repairing, Rebasing), a Class II device regulated under 21 CFR 872.3760. Juvora has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 13, 2017
- Date Received
- Apr 4, 2016
- 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)