FILTEK BULK FILL POSTERIOR RESTROATIVE— 510(k) K141081

Name: FDA 510(k) clearance K141081
Creator: U.S. Food and Drug Administration
Published: 2014-05-08

Substantially Equivalent

3M Espe Dental Products

FDA 510(k) clearance K141081 for FILTEK BULK FILL POSTERIOR RESTROATIVE, Substantially Equivalent on 2014-05-08. Applicant: 3M Espe Dental Products. Device class: 2.

Clearance details

Applicant: 3M Espe Dental Products
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2014-04-25
Decision date: 2014-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Saint Paul, MN, 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.