COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEM— 510(k) K022224

Name: FDA 510(k) clearance K022224
Creator: U.S. Food and Drug Administration
Published: 2002-09-18

Substantially Equivalent

Coltene AG

FDA 510(k) clearance K022224 for COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEM, Substantially Equivalent on 2002-09-18. Applicant: Coltene AG. Device class: 2.

Clearance details

Applicant: Coltene AG
Product code: Code DYH
Device class: Class 2
Regulation: 21 CFR 872.3750
Advisory panel: Dental
Date received: 2002-07-10
Decision date: 2002-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mahwah, NJ, US

Download summary PDF View on FDA.gov ↗

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