STRONG IMPLANT HANDPIECES— 510(k) K092412

Name: FDA 510(k) clearance K092412
Creator: U.S. Food and Drug Administration
Published: 2009-09-03

Substantially Equivalent

Saeshin Precision Co., Ltd.

FDA 510(k) clearance K092412 for STRONG IMPLANT HANDPIECES, Substantially Equivalent on 2009-09-03. Applicant: Saeshin Precision Co., Ltd.. Device class: 1.

Clearance details

Applicant: Saeshin Precision Co., Ltd.
Product code: Code EFA
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2009-08-06
Decision date: 2009-09-03
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.