DENTAURUM NO-MIX ONE STEP BRACKET ADHESIVE— 510(k) K030980

Name: FDA 510(k) clearance K030980
Creator: U.S. Food and Drug Administration
Published: 2003-08-25

Substantially Equivalent

Dentaurum

FDA 510(k) clearance K030980 for DENTAURUM NO-MIX ONE STEP BRACKET ADHESIVE, Substantially Equivalent on 2003-08-25. Applicant: Dentaurum. Device class: 2.

Clearance details

Applicant: Dentaurum
Product code: Code DYH
Device class: Class 2
Regulation: 21 CFR 872.3750
Advisory panel: Dental
Date received: 2003-03-28
Decision date: 2003-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newtown, PA, US

Download summary PDF View on FDA.gov ↗

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