Non-Sterile Zirconia Block
K-Number: K201492 · 2021-03-10
ApplicantBioden Co., Ltd.
Decision Date2021-03-10
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Non-Sterile Zirconia Block is a medical device manufactured by Bioden Co., Ltd.. It received FDA 510(k) clearance on 2021-03-10 under approval number K201492. 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 Non-Sterile Zirconia Block?
Non-Sterile Zirconia Block is a medical device that received FDA 510(k) clearance on 2021-03-10. It is manufactured by Bioden Co., Ltd.. The 510(k) number is K201492.
When was Non-Sterile Zirconia Block approved by the FDA?
Non-Sterile Zirconia Block received FDA 510(k) clearance on 2021-03-10, under approval number K201492.
What company makes Non-Sterile Zirconia Block?
Non-Sterile Zirconia Block is manufactured by Bioden Co., Ltd..
What is the FDA product code for Non-Sterile Zirconia Block?
The FDA product code for Non-Sterile Zirconia Block is EIH.
Other Devices by Bioden Co., Ltd.
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.