OPALUX VISIBLE LIGHT CURED ANTERIOR COMPOSITE— 510(k) K863882

Name: FDA 510(k) clearance K863882
Creator: U.S. Food and Drug Administration
Published: 1986-11-18

Substantially Equivalent

Coe Laboratories, Inc.

FDA 510(k) clearance K863882 for OPALUX VISIBLE LIGHT CURED ANTERIOR COMPOSITE, Substantially Equivalent on 1986-11-18. Applicant: Coe Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Coe Laboratories, Inc.
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 1986-10-06
Decision date: 1986-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alsip, IL, US

Download summary PDF View on FDA.gov ↗

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