SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S— 510(k) K132984

Name: FDA 510(k) clearance K132984
Creator: U.S. Food and Drug Administration
Published: 2014-01-14

Substantially Equivalent

Ivoclar Vivadent, Inc.

FDA 510(k) clearance K132984 for SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S, Substantially Equivalent on 2014-01-14. Applicant: Ivoclar Vivadent, Inc.. Device class: 2.

Clearance details

Applicant: Ivoclar Vivadent, Inc.
Product code: Code ELM
Device class: Class 2
Regulation: 21 CFR 872.3590
Advisory panel: Dental
Date received: 2013-09-24
Decision date: 2014-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Amherst, NY, US

Download summary PDF View on FDA.gov ↗

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