Perfit ZR HT Dental Zirconia blank
K-Number: K203351 · 2021-03-08
ApplicantVatech Acucera, Inc.
Decision Date2021-03-08
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Perfit ZR HT Dental Zirconia blank is a medical device manufactured by Vatech Acucera, Inc.. It received FDA 510(k) clearance on 2021-03-08 under approval number K203351. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Perfit ZR HT Dental Zirconia blank?
Perfit ZR HT Dental Zirconia blank is a medical device that received FDA 510(k) clearance on 2021-03-08. It is manufactured by Vatech Acucera, Inc.. The 510(k) number is K203351.
When was Perfit ZR HT Dental Zirconia blank approved by the FDA?
Perfit ZR HT Dental Zirconia blank received FDA 510(k) clearance on 2021-03-08, under approval number K203351.
What company makes Perfit ZR HT Dental Zirconia blank?
Perfit ZR HT Dental Zirconia blank is manufactured by Vatech Acucera, Inc..
What is the FDA product code for Perfit ZR HT Dental Zirconia blank?
The FDA product code for Perfit ZR HT Dental Zirconia blank is EIH.
Related Clinical Trials
Other Devices by Vatech Acucera, Inc.
Related Devices (Code: EIH)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.