ORAL B PLUS OUTLAST NIGHT TIME DENTAL GUARD— 510(k) K113326

Name: FDA 510(k) clearance K113326
Creator: U.S. Food and Drug Administration
Published: 2012-06-27

Substantially Equivalent

Oralabs, Inc.

FDA 510(k) clearance K113326 for ORAL B PLUS OUTLAST NIGHT TIME DENTAL GUARD, Substantially Equivalent on 2012-06-27. Applicant: Oralabs, Inc.. Device class: Unclassified.

Clearance details

Applicant: Oralabs, Inc.
Product code: Code OBR
Device class: Unclassified
Advisory panel: Unknown
Date received: 2011-11-10
Decision date: 2012-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parker, CO, US

Download summary PDF View on FDA.gov ↗

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