TOOTH SHADE RESIN MATERIAL— 510(k) K011453

Name: FDA 510(k) clearance K011453
Creator: U.S. Food and Drug Administration
Published: 2001-07-23

Substantially Equivalent

Rite-Dent Manufacturing Corp.

FDA 510(k) clearance K011453 for TOOTH SHADE RESIN MATERIAL, Substantially Equivalent on 2001-07-23. Applicant: Rite-Dent Manufacturing Corp.. Device class: 2.

Clearance details

Applicant: Rite-Dent Manufacturing Corp.
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2001-05-11
Decision date: 2001-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hialeah, FL, US

Download summary PDF View on FDA.gov ↗

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