Prime&Bond active Universal Adhesive— 510(k) K181476

Name: FDA 510(k) clearance K181476
Creator: U.S. Food and Drug Administration
Published: 2018-09-28

Substantially Equivalent

Dentsply Sirona

FDA 510(k) clearance K181476 for Prime&Bond active Universal Adhesive, Substantially Equivalent on 2018-09-28. Applicant: Dentsply Sirona. Device class: 2.

Clearance details

Applicant: Dentsply Sirona
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 2018-06-05
Decision date: 2018-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: York, PA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.