EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL— 510(k) K113818

Name: FDA 510(k) clearance K113818
Creator: U.S. Food and Drug Administration
Published: 2012-03-21

Substantially Equivalent

Pulpdent Corporation

FDA 510(k) clearance K113818 for EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL, Substantially Equivalent on 2012-03-21. Applicant: Pulpdent Corporation. Device class: 2.

Clearance details

Applicant: Pulpdent Corporation
Product code: Product code EBC
Device class: Class 2
Regulation: 21 CFR 872.3765
Advisory panel: Dental
Date received: 2011-12-27
Decision date: 2012-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Watertown, MA, 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.