FILAFEX TM, ESTHETIC ORTHODONTIC WIRE— 510(k) K843171

Name: FDA 510(k) clearance K843171
Creator: U.S. Food and Drug Administration
Published: 1984-12-03

Substantially Equivalent

Berkley and Co.

FDA 510(k) clearance K843171 for FILAFEX TM, ESTHETIC ORTHODONTIC WIRE, Substantially Equivalent on 1984-12-03. Applicant: Berkley and Co.. Device class: 1.

Clearance details

Applicant: Berkley and Co.
Product code: Code DZC
Device class: Class 1
Regulation: 21 CFR 872.5410
Advisory panel: Dental
Date received: 1984-08-13
Decision date: 1984-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spirit Lake, IA, US

Download summary PDF View on FDA.gov ↗

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