TEMREX-DENTIN VARNISH— 510(k) K851030

Substantially Equivalent

Temrex Corp.

FDA 510(k) clearance K851030 for TEMREX-DENTIN VARNISH, Substantially Equivalent on 1985-06-20. Applicant: Temrex Corp.. Device class: 2.

Clearance details

Applicant: Temrex Corp.
Product code: Code LBH
Device class: Class 2
Regulation: 21 CFR 872.3260
Advisory panel: Dental
Date received: 1985-03-12
Decision date: 1985-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Duarte, 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.