VENUS UNIVERSAL LIGHT CURING COMPOSITE— 510(k) K020131

Name: FDA 510(k) clearance K020131
Creator: U.S. Food and Drug Administration
Published: 2002-02-28

Substantially Equivalent

Heraeus Kulzer, Inc.

FDA 510(k) clearance K020131 for VENUS UNIVERSAL LIGHT CURING COMPOSITE, Substantially Equivalent on 2002-02-28. Applicant: Heraeus Kulzer, Inc.. Device class: 2.

Clearance details

Applicant: Heraeus Kulzer, Inc.
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2002-01-15
Decision date: 2002-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Bend, IN, US

Download summary PDF View on FDA.gov ↗

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