Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L— 510(k) K150076

Name: FDA 510(k) clearance K150076
Creator: U.S. Food and Drug Administration
Published: 2015-06-02

Substantially Equivalent

Dong IL Technology , Ltd.

FDA 510(k) clearance K150076 for Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L, Substantially Equivalent on 2015-06-02. Applicant: Dong IL Technology , Ltd.. Device class: 2.

Clearance details

Applicant: Dong IL Technology , Ltd.
Product code: Code DZI
Device class: Class 2
Regulation: 21 CFR 872.4120
Advisory panel: Dental
Date received: 2015-01-14
Decision date: 2015-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hwaseong-Si, Gyeonggi-Do, KR

Download summary PDF View on FDA.gov ↗

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