PERFECT CHOICE PROPHY PASTE WITH 10% CARBAMIDE PEROXIDE— 510(k) K962370

Name: FDA 510(k) clearance K962370
Creator: U.S. Food and Drug Administration
Published: 1997-03-31

Substantially Equivalent

Challenge Products, Inc.

FDA 510(k) clearance K962370 for PERFECT CHOICE PROPHY PASTE WITH 10% CARBAMIDE PEROXIDE, Substantially Equivalent on 1997-03-31. Applicant: Challenge Products, Inc.. Device class: 1.

Clearance details

Applicant: Challenge Products, Inc.
Product code: Code EJR
Device class: Class 1
Regulation: 21 CFR 872.6030
Advisory panel: Dental
Date received: 1996-06-19
Decision date: 1997-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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