BRUX MOUTHGUARDS— 510(k) K111310

Substantially Equivalent

Dental Arte, Inc.

FDA 510(k) clearance K111310 for BRUX MOUTHGUARDS, Substantially Equivalent on 2011-12-08. Applicant: Dental Arte, Inc.. Device class: Unclassified.

Clearance details

Applicant: Dental Arte, Inc.
Product code: Code OBR
Device class: Unclassified
Advisory panel: Unknown
Date received: 2011-05-10
Decision date: 2011-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Braderdon, FL, US

Download summary PDF View on FDA.gov ↗

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