510(k) K153534
K153534 is an FDA 510(k) premarket notification submitted by Nobel Biocare AB for the device "NobelProcera HT ML Full Contour Zirconia Crown". The FDA issued a decision of Substantially Equivalent on Jun 6, 2016. The device falls under product code ELL (Teeth, Porcelain), a Class II device regulated under 21 CFR 872.3920. Nobel Biocare AB has 95 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 6, 2016
- Date Received
- Dec 9, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Teeth, Porcelain
- Device Class
- Class II
- Regulation Number
- 872.3920
- Review Panel
- DE
- Submission Type
- 510(k)