SHOFU Enamel Conditioner
K-Number: K160086 · 2016-07-21
ApplicantShofu Dental Corporation
Decision Date2016-07-21
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
SHOFU Enamel Conditioner is a medical device manufactured by Shofu Dental Corporation. It received FDA 510(k) clearance on 2016-07-21 under approval number K160086. 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 SHOFU Enamel Conditioner?
SHOFU Enamel Conditioner is a medical device that received FDA 510(k) clearance on 2016-07-21. It is manufactured by Shofu Dental Corporation. The 510(k) number is K160086.
When was SHOFU Enamel Conditioner approved by the FDA?
SHOFU Enamel Conditioner received FDA 510(k) clearance on 2016-07-21, under approval number K160086.
What company makes SHOFU Enamel Conditioner?
SHOFU Enamel Conditioner is manufactured by Shofu Dental Corporation.
What is the FDA product code for SHOFU Enamel Conditioner?
The FDA product code for SHOFU Enamel Conditioner 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.