PREXION3D ECLIPSE— 510(k) K122199

Name: FDA 510(k) clearance K122199
Creator: U.S. Food and Drug Administration
Published: 2013-04-18

Substantially Equivalent

The Yoshida Dental Mfg. Co., Ltd.

FDA 510(k) clearance K122199 for PREXION3D ECLIPSE, Substantially Equivalent on 2013-04-18. Applicant: The Yoshida Dental Mfg. Co., Ltd.. Device class: 2.

Clearance details

Applicant: The Yoshida Dental Mfg. Co., Ltd.
Product code: Code OAS
Device class: Class 2
Regulation: 21 CFR 892.1750
Advisory panel: Radiology
Date received: 2012-07-24
Decision date: 2013-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chiyoda-Ku, Tokyo, JP

Download summary PDF View on FDA.gov ↗

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