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510(k) K033449

PRO-DENTEC DOUBLE-PRO PROPHYLAXIS PASTE WITH FLUOIDE FAMILY OF DEVICES by Professional Dental Technologies Therapeutics, Inc. — Product Code EJR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 2004
Date Received
October 29, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agent, Polishing, Abrasive, Oral Cavity
Device Class
Class I
Regulation Number
872.6030
Review Panel
DE
Submission Type

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