Prime&Bond active Universal Adhesive
K-Number: K181476 · 2018-09-28
ApplicantDentsply Sirona
Decision Date2018-09-28
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Prime&Bond active Universal Adhesive is a medical device manufactured by Dentsply Sirona. It received FDA 510(k) clearance on 2018-09-28 under approval number K181476. 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 Prime&Bond active Universal Adhesive?
Prime&Bond active Universal Adhesive is a medical device that received FDA 510(k) clearance on 2018-09-28. It is manufactured by Dentsply Sirona. The 510(k) number is K181476.
When was Prime&Bond active Universal Adhesive approved by the FDA?
Prime&Bond active Universal Adhesive received FDA 510(k) clearance on 2018-09-28, under approval number K181476.
What company makes Prime&Bond active Universal Adhesive?
Prime&Bond active Universal Adhesive is manufactured by Dentsply Sirona.
What is the FDA product code for Prime&Bond active Universal Adhesive?
The FDA product code for Prime&Bond active Universal Adhesive 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.