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510(k) Data Aggregation
K Number
K072754Device Name
AXENIC DHP DISPOSABLE HIGH-PERFORMANCE HANDPIECE
Manufacturer
Date Cleared
2008-01-25
(120 days)
Product Code
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
AXENIC DENTAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Axenic Dental, Inc. DHP™ "Disposable High-Performance" sterile, pyrogen free, maintenance free handpiece, with appropriate burs, is indicated for all dental practice procedures for which metal handpieces are used, including cutting, shaping and preparing teeth for cavity repair, crowns and bridges. The device is suitable for use in circumstances where infectious, inter-patient contamination is a concern. The device can be used for duration of 12 to 14 minutes cutting time during single patient use.
Device Description
The Axenic Dental, Inc. DHP™ "Disposable High-Performance Handpiece" is a sterile, single patient use, disposable instrument that is substantially equivalent to standard, re-usable, metal or plastic handpieces. All Axenic DHP™, high-speed, dental hand pieces are designed to operate at maximum specification outputs for 12 to 14 minutes of use. The single patient use nature of the instrument precludes any necessity for maintenance, cleaning, or sterilization.
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