REPLICA-F VISIBLE LIGHT-CURED ANT/POST DEN COM KIT— 510(k) K861546

Name: FDA 510(k) clearance K861546
Creator: U.S. Food and Drug Administration
Published: 1986-05-21

Substantially Equivalent

Macrochem Corp.

FDA 510(k) clearance K861546 for REPLICA-F VISIBLE LIGHT-CURED ANT/POST DEN COM KIT, Substantially Equivalent on 1986-05-21. Applicant: Macrochem Corp.. Device class: 2.

Clearance details

Applicant: Macrochem Corp.
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 1986-04-25
Decision date: 1986-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woburn, MA, US

Download summary PDF View on FDA.gov ↗

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