TOKUYAMA UNIVERSAL BOND
K-Number: K171226 · 2017-11-28
ApplicantTokuyama Dental Corporation
Decision Date2017-11-28
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
TOKUYAMA UNIVERSAL BOND is a medical device manufactured by Tokuyama Dental Corporation. It received FDA 510(k) clearance on 2017-11-28 under approval number K171226. 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 TOKUYAMA UNIVERSAL BOND?
TOKUYAMA UNIVERSAL BOND is a medical device that received FDA 510(k) clearance on 2017-11-28. It is manufactured by Tokuyama Dental Corporation. The 510(k) number is K171226.
When was TOKUYAMA UNIVERSAL BOND approved by the FDA?
TOKUYAMA UNIVERSAL BOND received FDA 510(k) clearance on 2017-11-28, under approval number K171226.
What company makes TOKUYAMA UNIVERSAL BOND?
TOKUYAMA UNIVERSAL BOND is manufactured by Tokuyama Dental Corporation.
What is the FDA product code for TOKUYAMA UNIVERSAL BOND?
The FDA product code for TOKUYAMA UNIVERSAL BOND 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.