BEAUTIFIL II LS
K-Number: K160596 · 2016-07-27
ApplicantShofu Dental Corporation
Decision Date2016-07-27
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
BEAUTIFIL II LS is a medical device manufactured by Shofu Dental Corporation. It received FDA 510(k) clearance on 2016-07-27 under approval number K160596. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BEAUTIFIL II LS?
BEAUTIFIL II LS is a medical device that received FDA 510(k) clearance on 2016-07-27. It is manufactured by Shofu Dental Corporation. The 510(k) number is K160596.
When was BEAUTIFIL II LS approved by the FDA?
BEAUTIFIL II LS received FDA 510(k) clearance on 2016-07-27, under approval number K160596.
What company makes BEAUTIFIL II LS?
BEAUTIFIL II LS is manufactured by Shofu Dental Corporation.
What is the FDA product code for BEAUTIFIL II LS?
The FDA product code for BEAUTIFIL II LS is EBF.
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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.