BONE PLUS BCP EAGLE EYE— 510(k) K122240

Name: FDA 510(k) clearance K122240
Creator: U.S. Food and Drug Administration
Published: 2012-08-21

Substantially Equivalent

Megagen Implant Co., Ltd.

FDA 510(k) clearance K122240 for BONE PLUS BCP EAGLE EYE, Substantially Equivalent on 2012-08-21. Applicant: Megagen Implant Co., Ltd.. Device class: 2.

Clearance details

Applicant: Megagen Implant Co., Ltd.
Product code: Code LYC
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2012-07-27
Decision date: 2012-08-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Brea, 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.