Peak Universal Bond
K-Number: K240743 · 2024-03-20
ApplicantUltradent Products, Inc.
Decision Date2024-03-20
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Peak Universal Bond is a medical device manufactured by Ultradent Products, Inc.. It received FDA 510(k) clearance on 2024-03-20 under approval number K240743. 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 Peak Universal Bond?
Peak Universal Bond is a medical device that received FDA 510(k) clearance on 2024-03-20. It is manufactured by Ultradent Products, Inc.. The 510(k) number is K240743.
When was Peak Universal Bond approved by the FDA?
Peak Universal Bond received FDA 510(k) clearance on 2024-03-20, under approval number K240743.
What company makes Peak Universal Bond?
Peak Universal Bond is manufactured by Ultradent Products, Inc..
What is the FDA product code for Peak Universal Bond?
The FDA product code for Peak 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.