510(k) K161025
K161025 is an FDA 510(k) premarket notification submitted by Pritidenta GmbH for the device "priti multidisc ZrO2 High Translucent". The FDA issued a decision of Substantially Equivalent on Feb 3, 2017. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 3, 2017
- Date Received
- Apr 12, 2016
- 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
- 510(k)