510(k) K201915
K201915 is an FDA 510(k) premarket notification submitted by United Dental Resources Corporation for the device "GenesisZr 4Y+ (ST1100) Zirconia". The FDA issued a decision of Substantially Equivalent on Feb 23, 2021. 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
- Feb 23, 2021
- Date Received
- Jul 10, 2020
- 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)