BEAUTIFIL II Gingiva
K-Number: K151700 · 2016-03-02
ApplicantShofu Dental Corporation
Decision Date2016-03-02
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
BEAUTIFIL II Gingiva is a medical device manufactured by Shofu Dental Corporation. It received FDA 510(k) clearance on 2016-03-02 under approval number K151700. 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 Gingiva?
BEAUTIFIL II Gingiva is a medical device that received FDA 510(k) clearance on 2016-03-02. It is manufactured by Shofu Dental Corporation. The 510(k) number is K151700.
When was BEAUTIFIL II Gingiva approved by the FDA?
BEAUTIFIL II Gingiva received FDA 510(k) clearance on 2016-03-02, under approval number K151700.
What company makes BEAUTIFIL II Gingiva?
BEAUTIFIL II Gingiva is manufactured by Shofu Dental Corporation.
What is the FDA product code for BEAUTIFIL II Gingiva?
The FDA product code for BEAUTIFIL II Gingiva 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.