REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH— 510(k) K070591

Name: FDA 510(k) clearance K070591
Creator: U.S. Food and Drug Administration
Published: 2007-05-11

Substantially Equivalent

Union Dental S.A./Unidesa.Odi

FDA 510(k) clearance K070591 for REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH, Substantially Equivalent on 2007-05-11. Applicant: Union Dental S.A./Unidesa.Odi. Device class: 2.

Clearance details

Applicant: Union Dental S.A./Unidesa.Odi
Product code: Code ELM
Device class: Class 2
Regulation: 21 CFR 872.3590
Advisory panel: Dental
Date received: 2007-03-01
Decision date: 2007-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tielmes, Madrid, ES

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.