510(k) K182642
K182642 is an FDA 510(k) premarket notification submitted by United Dental Resources Corporation for the device "GenesisZr 4Y Zirconia". The FDA issued a decision of Substantially Equivalent on Jan 25, 2019. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660. United Dental Resources Corporation has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 25, 2019
- Date Received
- Sep 24, 2018
- 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)