OSTEOMED TEMPORARY CONDYLAR ATTACHMENT SYSTEM— 510(k) K031701

Name: FDA 510(k) clearance K031701
Creator: U.S. Food and Drug Administration
Published: 2004-07-08

Substantially Equivalent

Osteomed LP

FDA 510(k) clearance K031701 for OSTEOMED TEMPORARY CONDYLAR ATTACHMENT SYSTEM, Substantially Equivalent on 2004-07-08. Applicant: Osteomed LP. Device class: 2.

Clearance details

Applicant: Osteomed LP
Product code: Code NEI
Device class: Class 2
Regulation: 21 CFR 872.4770
Advisory panel: Dental
Date received: 2003-06-02
Decision date: 2004-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Addison, TX, US

Download summary PDF View on FDA.gov ↗

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