Zirconia Dental Ceramics
K-Number: K170894 · 2017-08-01
Decision Date2017-08-01
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Zirconia Dental Ceramics is a medical device manufactured by Chengdu Besmile Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2017-08-01 under approval number K170894. 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 Zirconia Dental Ceramics?
Zirconia Dental Ceramics is a medical device that received FDA 510(k) clearance on 2017-08-01. It is manufactured by Chengdu Besmile Biotechnology Co., Ltd.. The 510(k) number is K170894.
When was Zirconia Dental Ceramics approved by the FDA?
Zirconia Dental Ceramics received FDA 510(k) clearance on 2017-08-01, under approval number K170894.
What company makes Zirconia Dental Ceramics?
Zirconia Dental Ceramics is manufactured by Chengdu Besmile Biotechnology Co., Ltd..
What is the FDA product code for Zirconia Dental Ceramics?
The FDA product code for Zirconia Dental Ceramics is EIH.
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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.