ARISTEE (RESIN, CROWN AND BRIDGES)— 510(k) K900068

Name: FDA 510(k) clearance K900068
Creator: U.S. Food and Drug Administration
Published: 1990-04-03

Substantially Equivalent

Prometex, Inc.

FDA 510(k) clearance K900068 for ARISTEE (RESIN, CROWN AND BRIDGES), Substantially Equivalent on 1990-04-03. Applicant: Prometex, Inc.. Device class: 2.

Clearance details

Applicant: Prometex, Inc.
Product code: Code EBG
Device class: Class 2
Regulation: 21 CFR 872.3770
Advisory panel: Dental
Date received: 1990-01-04
Decision date: 1990-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, 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.