POLYBONE DENTAL— 510(k) K092194

Substantially Equivalent

Kyung Won Medical Co., Ltd.

FDA 510(k) clearance K092194 for POLYBONE DENTAL, Substantially Equivalent on 2010-06-16. Applicant: Kyung Won Medical Co., Ltd.. Device class: 2.

Clearance details

Applicant: Kyung Won Medical Co., Ltd.
Product code: Code LYC
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2009-07-21
Decision date: 2010-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Fe Springs, 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.