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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona. It received FDA 510(k) clearance on 2018-09-28 under 510(k) 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. The listed applicant is Dentsply Sirona. The 510(k) number is K181476.

When did Prime&Bond active Universal Adhesive receive FDA 510(k) clearance?

Prime&Bond active Universal Adhesive received FDA 510(k) clearance on 2018-09-28, under 510(k) number K181476.

Who is the listed applicant for Prime&Bond active Universal Adhesive?

The FDA 510(k) record lists Dentsply Sirona as the applicant. This does not by itself establish the device manufacturer.

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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Related Devices (Code: 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.

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