EMBRACE WETBOND RESTORATION AND PFM REPAIR KIT— 510(k) K032953

Name: FDA 510(k) clearance K032953
Creator: U.S. Food and Drug Administration
Published: 2003-12-10

Substantially Equivalent

Pulpdent Corporation

FDA 510(k) clearance K032953 for EMBRACE WETBOND RESTORATION AND PFM REPAIR KIT, Substantially Equivalent on 2003-12-10. Applicant: Pulpdent Corporation. Device class: 2.

Clearance details

Applicant: Pulpdent Corporation
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 2003-09-22
Decision date: 2003-12-10
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.