Pulpdent Solo Flowable Composite with MCP— 510(k) K153249

Name: FDA 510(k) clearance K153249
Creator: U.S. Food and Drug Administration
Published: 2016-04-01

Substantially Equivalent

Pulpdent Corporation

FDA 510(k) clearance K153249 for Pulpdent Solo Flowable Composite with MCP, Substantially Equivalent on 2016-04-01. Applicant: Pulpdent Corporation. Device class: 2.

Clearance details

Applicant: Pulpdent Corporation
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2015-11-09
Decision date: 2016-04-01
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.