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510(k) K083695

TRAXODENT by Premier Dental Products Co. — Product Code MVL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 2009
Date Received
December 15, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cord, Retraction
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type

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