Non-Sterile Zirconia Block
K-Number: K190112 · 2019-12-20
ApplicantFine Advanced Compound Co., Ltd.
Decision Date2019-12-20
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Non-Sterile Zirconia Block is a medical device manufactured by Fine Advanced Compound Co., Ltd.. It received FDA 510(k) clearance on 2019-12-20 under approval number K190112. 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 2019-12-20. It is manufactured by Fine Advanced Compound Co., Ltd.. The 510(k) number is K190112.
When was Non-Sterile Zirconia Block approved by the FDA?
Non-Sterile Zirconia Block received FDA 510(k) clearance on 2019-12-20, under approval number K190112.
What company makes Non-Sterile Zirconia Block?
Non-Sterile Zirconia Block is manufactured by Fine Advanced Compound Co., Ltd..
What is the FDA product code for Non-Sterile Zirconia Block?
The FDA product code for Non-Sterile Zirconia Block is EIH.
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.