UNITEK CERAMIC BRACKET SYSTEM— 510(k) K861965

Substantially Equivalent

Unitek Corp.

FDA 510(k) clearance K861965 for UNITEK CERAMIC BRACKET SYSTEM, Substantially Equivalent on 1986-06-09. Applicant: Unitek Corp.. Device class: 2.

Clearance details

Applicant: Unitek Corp.
Product code: Code DYW
Device class: Class 2
Regulation: 21 CFR 872.5470
Advisory panel: Dental
Date received: 1986-05-19
Decision date: 1986-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monrovia, CA, 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.