ENAMEL BONDING SYSTEM— 510(k) K020050

Name: FDA 510(k) clearance K020050
Creator: U.S. Food and Drug Administration
Published: 2002-02-14

Substantially Equivalent

Rite-Dent Manufacturing Corp.

FDA 510(k) clearance K020050 for ENAMEL BONDING SYSTEM, Substantially Equivalent on 2002-02-14. Applicant: Rite-Dent Manufacturing Corp.. Device class: 2.

Clearance details

Applicant: Rite-Dent Manufacturing Corp.
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 2002-01-07
Decision date: 2002-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hialeah, FL, US

Download summary PDF View on FDA.gov ↗

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