DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENT— 510(k) K120283

Name: FDA 510(k) clearance K120283
Creator: U.S. Food and Drug Administration
Published: 2012-07-31

Substantially Equivalent

Novocol, Inc.

FDA 510(k) clearance K120283 for DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENT, Substantially Equivalent on 2012-07-31. Applicant: Novocol, Inc.. Device class: 2.

Clearance details

Applicant: Novocol, Inc.
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 2012-01-31
Decision date: 2012-07-31
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Louisville, CO, US

Download summary PDF View on FDA.gov ↗

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