Pre-Milled Blank
K-Number: K193425 · 2020-03-09
ApplicantArum Dentistry Co., Ltd.
Decision Date2020-03-09
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Pre-Milled Blank is a medical device manufactured by Arum Dentistry Co., Ltd.. It received FDA 510(k) clearance on 2020-03-09 under approval number K193425. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Pre-Milled Blank?
Pre-Milled Blank is a medical device that received FDA 510(k) clearance on 2020-03-09. It is manufactured by Arum Dentistry Co., Ltd.. The 510(k) number is K193425.
When was Pre-Milled Blank approved by the FDA?
Pre-Milled Blank received FDA 510(k) clearance on 2020-03-09, under approval number K193425.
What company makes Pre-Milled Blank?
Pre-Milled Blank is manufactured by Arum Dentistry Co., Ltd..
What is the FDA product code for Pre-Milled Blank?
The FDA product code for Pre-Milled Blank is NHA.
Other Devices by Arum Dentistry Co., Ltd.
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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.