510(k) K203499
K203499 is an FDA 510(k) premarket notification submitted by Vatech Acucera, Inc. for the device "Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank". The FDA issued a decision of Substantially Equivalent on Apr 5, 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
- Apr 5, 2021
- Date Received
- Nov 27, 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)