BEAUTIFIL II
K-Number: K251578 · 2025-05-27
ApplicantShofu Dental Corporation
Decision Date2025-05-27
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
BEAUTIFIL II is a medical device manufactured by Shofu Dental Corporation. It received FDA 510(k) clearance on 2025-05-27 under approval number K251578. 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?
BEAUTIFIL II is a medical device that received FDA 510(k) clearance on 2025-05-27. It is manufactured by Shofu Dental Corporation. The 510(k) number is K251578.
When was BEAUTIFIL II approved by the FDA?
BEAUTIFIL II received FDA 510(k) clearance on 2025-05-27, under approval number K251578.
What company makes BEAUTIFIL II?
BEAUTIFIL II is manufactured by Shofu Dental Corporation.
What is the FDA product code for BEAUTIFIL II?
The FDA product code for BEAUTIFIL II 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.