Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
K-Number: K230003 · 2023-03-31
ApplicantTopzir Biotech Co., Ltd.
Decision Date2023-03-31
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is a medical device manufactured by Topzir Biotech Co., Ltd.. It received FDA 510(k) clearance on 2023-03-31 under approval number K230003. 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 Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank?
Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is a medical device that received FDA 510(k) clearance on 2023-03-31. It is manufactured by Topzir Biotech Co., Ltd.. The 510(k) number is K230003.
When was Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank approved by the FDA?
Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank received FDA 510(k) clearance on 2023-03-31, under approval number K230003.
What company makes Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank?
Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is manufactured by Topzir Biotech Co., Ltd..
What is the FDA product code for Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank?
The FDA product code for Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is EIH.
Related Clinical Trials
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.