N1— 510(k) K232012

Substantially Equivalent

Osstem Implant Co., Ltd.

FDA 510(k) clearance K232012 for N1, Substantially Equivalent on 2023-11-28. Applicant: Osstem Implant Co., Ltd.. Device class: 2.

Clearance details

Applicant: Osstem Implant Co., Ltd.
Product code: Code EHD
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2023-07-06
Decision date: 2023-11-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Siheung-Si, 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.