TRANSBOND IDB PRE-MIX CHEMICAL CARE ADHESIVE— 510(k) K100536

Name: FDA 510(k) clearance K100536
Creator: U.S. Food and Drug Administration
Published: 2010-07-27

Substantially Equivalent

3M Unitek

FDA 510(k) clearance K100536 for TRANSBOND IDB PRE-MIX CHEMICAL CARE ADHESIVE, Substantially Equivalent on 2010-07-27. Applicant: 3M Unitek. Device class: 2.

Clearance details

Applicant: 3M Unitek
Product code: Code DYH
Device class: Class 2
Regulation: 21 CFR 872.3750
Advisory panel: Dental
Date received: 2010-02-25
Decision date: 2010-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monrovia, 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.