BeautiBond Xtreme
K-Number: K213965 · 2022-03-18
ApplicantShofu Dental Corporation
Decision Date2022-03-18
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
BeautiBond Xtreme is a medical device manufactured by Shofu Dental Corporation. It received FDA 510(k) clearance on 2022-03-18 under approval number K213965. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BeautiBond Xtreme?
BeautiBond Xtreme is a medical device that received FDA 510(k) clearance on 2022-03-18. It is manufactured by Shofu Dental Corporation. The 510(k) number is K213965.
When was BeautiBond Xtreme approved by the FDA?
BeautiBond Xtreme received FDA 510(k) clearance on 2022-03-18, under approval number K213965.
What company makes BeautiBond Xtreme?
BeautiBond Xtreme is manufactured by Shofu Dental Corporation.
What is the FDA product code for BeautiBond Xtreme?
The FDA product code for BeautiBond Xtreme is KLE.
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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.