GAMMA-BSM; BETA-BSM; EQUIVABONE— 510(k) K102812

Name: FDA 510(k) clearance K102812
Creator: U.S. Food and Drug Administration
Published: 2010-12-03

Substantially Equivalent

Etex Corporation

FDA 510(k) clearance K102812 for GAMMA-BSM; BETA-BSM; EQUIVABONE, Substantially Equivalent on 2010-12-03. Applicant: Etex Corporation. Device class: 2.

Clearance details

Applicant: Etex Corporation
Product code: Code LYC
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2010-09-28
Decision date: 2010-12-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Cambridge, MA, 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.