PROLINK ADHESIVES (PROLINK, PROLINK SE)— 510(k) K110403

Name: FDA 510(k) clearance K110403
Creator: U.S. Food and Drug Administration
Published: 2011-09-08

Substantially Equivalent

Silmet , Ltd.

FDA 510(k) clearance K110403 for PROLINK ADHESIVES (PROLINK, PROLINK SE), Substantially Equivalent on 2011-09-08. Applicant: Silmet , Ltd.. Device class: 2.

Clearance details

Applicant: Silmet , Ltd.
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 2011-02-11
Decision date: 2011-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Or Yehuda, IL

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.