Tokuyama Universal Bond II
K-Number: K203760 · 2021-05-25
ApplicantTokuyama Dental Corporation
Decision Date2021-05-25
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Tokuyama Universal Bond II is a medical device manufactured by Tokuyama Dental Corporation. It received FDA 510(k) clearance on 2021-05-25 under approval number K203760. 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 II?
Tokuyama Universal Bond II is a medical device that received FDA 510(k) clearance on 2021-05-25. It is manufactured by Tokuyama Dental Corporation. The 510(k) number is K203760.
When was Tokuyama Universal Bond II approved by the FDA?
Tokuyama Universal Bond II received FDA 510(k) clearance on 2021-05-25, under approval number K203760.
What company makes Tokuyama Universal Bond II?
Tokuyama Universal Bond II is manufactured by Tokuyama Dental Corporation.
What is the FDA product code for Tokuyama Universal Bond II?
The FDA product code for Tokuyama Universal Bond II 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.