SHOFU RESIN GLAZE
K-Number: K163568 · 2017-08-16
ApplicantShofu Dental Corporation
Decision Date2017-08-16
Product CodeEBD
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
SHOFU RESIN GLAZE is a medical device manufactured by Shofu Dental Corporation. It received FDA 510(k) clearance on 2017-08-16 under approval number K163568. The device is classified under product code EBD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SHOFU RESIN GLAZE?
SHOFU RESIN GLAZE is a medical device that received FDA 510(k) clearance on 2017-08-16. It is manufactured by Shofu Dental Corporation. The 510(k) number is K163568.
When was SHOFU RESIN GLAZE approved by the FDA?
SHOFU RESIN GLAZE received FDA 510(k) clearance on 2017-08-16, under approval number K163568.
What company makes SHOFU RESIN GLAZE?
SHOFU RESIN GLAZE is manufactured by Shofu Dental Corporation.
What is the FDA product code for SHOFU RESIN GLAZE?
The FDA product code for SHOFU RESIN GLAZE is EBD.
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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.