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510(k) Data Aggregation
K Number
K033449Device Name
PRO-DENTEC DOUBLE-PRO PROPHYLAXIS PASTE WITH FLUOIDE FAMILY OF DEVICES
Date Cleared
2004-01-07
(70 days)
Product Code
Regulation Number
872.6030Why did this record match?
Applicant Name (Manufacturer) :
PROFESSIONAL DENTAL TECHNOLOGIES THERAPEUTICS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
To be used for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment.
Device Description
The Double-Pro™ Prophylaxis Paste with Fluoride family of devices, manufactured by Professional Dental Technologies Therapeutics, Inc., are oral cavity abrasive polishing agents that contain fluoride, an abrasive (in one of several available levels of grit courseness), a swectener, water, flavoring, color, thickeners, and preservatives. Double-Pro™ is intended for use by dental professionals, during professionally administered dental prophylaxis treatment (tooth-cleaning), to polish and clean calculus, stains, and other accretions from the teeth. Double Pro™ prophy paste is applied to patients' teeth with a prophy angle and rotating rubber cup. Use of Double-ProTM Prophylaxis Paste with Fluoride family of devices is to be limited to individuals who are professional trained to perform dental prophylaxis.
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