COLTENE BRILLIANT D.I. DIRECT INLAY SYSTEM— 510(k) K870266

Name: FDA 510(k) clearance K870266
Creator: U.S. Food and Drug Administration
Published: 1987-02-27

Substantially Equivalent

Coltene, Inc.

FDA 510(k) clearance K870266 for COLTENE BRILLIANT D.I. DIRECT INLAY SYSTEM, Substantially Equivalent on 1987-02-27. Applicant: Coltene, Inc.. Device class: 2.

Clearance details

Applicant: Coltene, Inc.
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 1987-01-23
Decision date: 1987-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, 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.