CONCEPT HP ADD-ON; CONCEPT HP ENAMEL— 510(k) K033773

Name: FDA 510(k) clearance K033773
Creator: U.S. Food and Drug Administration
Published: 2004-01-15

Substantially Equivalent

Ivoclar Vivadent, AG

FDA 510(k) clearance K033773 for CONCEPT HP ADD-ON; CONCEPT HP ENAMEL, Substantially Equivalent on 2004-01-15. Applicant: Ivoclar Vivadent, AG. Device class: 2.

Clearance details

Applicant: Ivoclar Vivadent, AG
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2003-12-03
Decision date: 2004-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Amherst, NY, 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.