TRILUX, Z-TONE, ACRY ROCK— 510(k) K022299

Name: FDA 510(k) clearance K022299
Creator: U.S. Food and Drug Administration
Published: 2002-10-07

Substantially Equivalent

Ruthibras Imp. Exp. Com. DE Materiais Odontologico

FDA 510(k) clearance K022299 for TRILUX, Z-TONE, ACRY ROCK, Substantially Equivalent on 2002-10-07. Applicant: Ruthibras Imp. Exp. Com. DE Materiais Odontologico. Device class: 2.

Clearance details

Applicant: Ruthibras Imp. Exp. Com. DE Materiais Odontologico
Product code: Code ELM
Device class: Class 2
Regulation: 21 CFR 872.3590
Advisory panel: Dental
Date received: 2002-07-16
Decision date: 2002-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Littleton, CO, 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.