510(k) K191304
K191304 is an FDA 510(k) premarket notification submitted by Besorah Dental Solutions NZ Limited for the device "EthanZir Zirconia". The FDA issued a decision of Substantially Equivalent on Nov 4, 2019. 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
- Nov 4, 2019
- Date Received
- May 14, 2019
- 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)