OPTIBOND; OPTIAID, OPTIREP, OPTISHINE, OPTICHROMA, OPTIFARB & OPTIWAK— 510(k) K955070

Name: FDA 510(k) clearance K955070
Creator: U.S. Food and Drug Administration
Published: 1995-12-11

Substantially Equivalent

Optimal Dental (Usa)

FDA 510(k) clearance K955070 for OPTIBOND; OPTIAID, OPTIREP, OPTISHINE, OPTICHROMA, OPTIFARB & OPTIWAK, Substantially Equivalent on 1995-12-11. Applicant: Optimal Dental (Usa). Device class: 2.

Clearance details

Applicant: Optimal Dental (Usa)
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 1995-11-06
Decision date: 1995-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.