Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
K-Number: K212259 · 2021-11-12
ApplicantZirdent New Material Co., Ltd.
Decision Date2021-11-12
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is a medical device manufactured by Zirdent New Material Co., Ltd.. It received FDA 510(k) clearance on 2021-11-12 under approval number K212259. 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 Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank?
Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is a medical device that received FDA 510(k) clearance on 2021-11-12. It is manufactured by Zirdent New Material Co., Ltd.. The 510(k) number is K212259.
When was Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank approved by the FDA?
Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank received FDA 510(k) clearance on 2021-11-12, under approval number K212259.
What company makes Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank?
Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is manufactured by Zirdent New Material Co., Ltd..
What is the FDA product code for Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank?
The FDA product code for Zirdent 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.