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510(k) K062828

MOUTHGUARD AND ALIGNER MATERIALS by Dentsply Intl., Inc. — Product Code MQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 2006
Date Received
September 20, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mouthguard, Prescription
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type

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