510(k) K203351
K203351 is an FDA 510(k) premarket notification submitted by Vatech Acucera, Inc. for the device "Perfit ZR HT Dental Zirconia blank". The FDA issued a decision of Substantially Equivalent on Mar 8, 2021. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660. Vatech Acucera, Inc. has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 8, 2021
- Date Received
- Nov 13, 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)