ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE— 510(k) K091729

Name: FDA 510(k) clearance K091729
Creator: U.S. Food and Drug Administration
Published: 2009-12-23

Substantially Equivalent

Etex Corp.

FDA 510(k) clearance K091729 for ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE, Substantially Equivalent on 2009-12-23. Applicant: Etex Corp.. Device class: 2.

Clearance details

Applicant: Etex Corp.
Product code: Code LYC
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2009-06-11
Decision date: 2009-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
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.