ENAMELITE ACRYSEAL SPRAY SEALANT— 510(k) K093019

Name: FDA 510(k) clearance K093019
Creator: U.S. Food and Drug Administration
Published: 2009-12-22

Substantially Equivalent

Enamelite, LLC

FDA 510(k) clearance K093019 for ENAMELITE ACRYSEAL SPRAY SEALANT, Substantially Equivalent on 2009-12-22. Applicant: Enamelite, LLC. Device class: 2.

Clearance details

Applicant: Enamelite, LLC
Product code: Code EBD
Device class: Class 2
Regulation: 21 CFR 872.3310
Advisory panel: Dental
Date received: 2009-09-29
Decision date: 2009-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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