Regenomer® Syringe, Regenomer® Plug, Regenomer® Block— 510(k) K150079

Name: FDA 510(k) clearance K150079
Creator: U.S. Food and Drug Administration
Published: 2015-12-10

Substantially Equivalent

Nibec Co., Ltd.

FDA 510(k) clearance K150079 for Regenomer® Syringe, Regenomer® Plug, Regenomer® Block, Substantially Equivalent on 2015-12-10. Applicant: Nibec Co., Ltd.. Device class: 2.

Clearance details

Applicant: Nibec Co., Ltd.
Product code: Code NPM
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2015-01-15
Decision date: 2015-12-10
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Jincheon-Gun, KR

Download summary PDF View on FDA.gov ↗

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