Premier Sealant— 510(k) K161580

Name: FDA 510(k) clearance K161580
Creator: U.S. Food and Drug Administration
Published: 2016-10-18

Substantially Equivalent

Premier Dental Company Products

FDA 510(k) clearance K161580 for Premier Sealant, Substantially Equivalent on 2016-10-18. Applicant: Premier Dental Company Products. Device class: 2.

Clearance details

Applicant: Premier Dental Company Products
Product code: Code EBC
Device class: Class 2
Regulation: 21 CFR 872.3765
Advisory panel: Dental
Date received: 2016-06-08
Decision date: 2016-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth Meeting, 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.