TOKUYAMA CUREGRACE
K-Number: K170549 · 2017-07-05
ApplicantTokuyama Dental Corporation
Decision Date2017-07-05
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
TOKUYAMA CUREGRACE is a medical device manufactured by Tokuyama Dental Corporation. It received FDA 510(k) clearance on 2017-07-05 under approval number K170549. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TOKUYAMA CUREGRACE?
TOKUYAMA CUREGRACE is a medical device that received FDA 510(k) clearance on 2017-07-05. It is manufactured by Tokuyama Dental Corporation. The 510(k) number is K170549.
When was TOKUYAMA CUREGRACE approved by the FDA?
TOKUYAMA CUREGRACE received FDA 510(k) clearance on 2017-07-05, under approval number K170549.
What company makes TOKUYAMA CUREGRACE?
TOKUYAMA CUREGRACE is manufactured by Tokuyama Dental Corporation.
What is the FDA product code for TOKUYAMA CUREGRACE?
The FDA product code for TOKUYAMA CUREGRACE is EBI.
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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.