Transcend
K-Number: K201795 · 2020-09-28
ApplicantUltradent Product, Inc.
Decision Date2020-09-28
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Transcend is a medical device manufactured by Ultradent Product, Inc.. It received FDA 510(k) clearance on 2020-09-28 under approval number K201795. 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 Transcend?
Transcend is a medical device that received FDA 510(k) clearance on 2020-09-28. It is manufactured by Ultradent Product, Inc.. The 510(k) number is K201795.
When was Transcend approved by the FDA?
Transcend received FDA 510(k) clearance on 2020-09-28, under approval number K201795.
What company makes Transcend?
Transcend is manufactured by Ultradent Product, Inc..
What is the FDA product code for Transcend?
The FDA product code for Transcend 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.