OSTEON, OSTEON SINUS, OSTEON LIFTING— 510(k) K102015

Name: FDA 510(k) clearance K102015
Creator: U.S. Food and Drug Administration
Published: 2010-11-19

Substantially Equivalent

Genoss Co., Ltd.

FDA 510(k) clearance K102015 for OSTEON, OSTEON SINUS, OSTEON LIFTING, Substantially Equivalent on 2010-11-19. Applicant: Genoss Co., Ltd.. Device class: 2.

Clearance details

Applicant: Genoss Co., Ltd.
Product code: Code LYC
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2010-07-16
Decision date: 2010-11-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Cypress, CA, 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.