ARISTEE (TEMPORARY CROWN & BRIDGE RESIN)— 510(k) K892710

Name: FDA 510(k) clearance K892710
Creator: U.S. Food and Drug Administration
Published: 1989-10-24

Substantially Equivalent

Prometex, Inc.

FDA 510(k) clearance K892710 for ARISTEE (TEMPORARY CROWN & BRIDGE RESIN), Substantially Equivalent on 1989-10-24. 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: 1989-04-14
Decision date: 1989-10-24
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.