K3— 510(k) K152830

Substantially Equivalent

Osstem Implant Co., Ltd.

FDA 510(k) clearance K152830 for K3, Substantially Equivalent on 2017-04-20. Applicant: Osstem Implant Co., Ltd.. Device class: 1.

Clearance details

Applicant: Osstem Implant Co., Ltd.
Product code: Code EIA
Device class: Class 1
Regulation: 21 CFR 872.6640
Advisory panel: Dental
Date received: 2015-09-29
Decision date: 2017-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.