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510(k) Data Aggregation
K Number
K090369Device Name
PRODRIVE LINE OF DENTAL HANDPIECES
Manufacturer
PRODRIVE SYSTEMS, INC.
Date Cleared
2009-02-27
(14 days)
Product Code
EFB, PRO
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
PRODRIVE SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To be used in the dental operatory to prepare dental cavities for restorations such as fillings, and for cleaning teeth.
Device Description
The ProDrive line of high-speed air-driven dental handpieces includes two models - the ProDrive Mini and ProDrive Standard. These models are each available with one of a variety of quick couplings for use with: Sirona, KaVo, W&H, Bien-Air, NSK Mach and NSK QD-J connections. In addition, the PD Standard model comes in a fixed coupling format for MidWest handpiece users. The handpieces come supplied with a halogen light source of approximately 25,000 lux and a 3 jet spray for water. Every ProDrive handpiece is equipped with the previously-cleared ProDrive turbine as the standard drive mechanism. The ProDrive turbine is appropriate for use with ProDrive carbide and diamond cutting instruments. A push-button spindle mechanism is used to grip the shanks of the cutting instruments. The unique geometry of the bur shank and turbine spindle securely locks the bur in the turbine eliminating the slipping that can occur over time with traditional burs and turbines. In addition to improved performance and durability, the secure locking mechanism enhances the safety of the ProDrive Replacement Turbine by reducing the risk of accidental disengagement of burs from the handpiece during operation. In addition, the ProDrive system incorporates the ability to index the bur to a second, extended, position effectively improving on the visibility angle and the utility of the handpiece without adversely affecting its performance.
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K Number
K073353Device Name
DO-ALL DENTAL HANDPIECE LUBRICANT
Manufacturer
PRODRIVE SYSTEMS, INC.
Date Cleared
2007-12-07
(8 days)
Product Code
EFB
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
PRODRIVE SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To be used to lubricate air driven dental handpieces, turbines and air motors for the purpose of maintenance prior to sterilization.
Device Description
DO-ALL is a lubricant designed for use with air-powered dental handpieces. The product is intended to be used prior to handpiece sterilization to lubricate the moving parts inside of the air-powered turbine. The lubricant is not intended to come into contact with the patient and has no therapeutic function.
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K Number
K062219Device Name
PRODRIVE SYSTEMS REPLACEMENT TURBINE
Manufacturer
PRODRIVE SYSTEMS, INC.
Date Cleared
2006-08-04
(2 days)
Product Code
EFB, EFA
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
PRODRIVE SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To be used intraorally by trained dental professionals for drilling and preparation of dental cavities for restoration, such as fillings.
Device Description
The ProDrive Replacement Turbine is a high-speed air-powered turbine designed to be installed in existing, legally marketed dental handpieces. The ProDrive Replacement Turbine is appropriate for use with ProDrive carbide and diamond cutting instruments. A push-button spindle mechanism is used to grip the shanks of the cutting instruments. The unique geometry of the bur shank and turbine spindle securely locks the bur in the turbine eliminating the slipping that can occur over time with traditional burs and turbines. In addition to improved performance and durability, the secure locking mechanism enhances the safety of the ProDrive Replacement Turbine by reducing the risk of accidental disengagement of burs from the handpiece during operation. When fully seated, the length that the ProDrive bur extends from the handpiece is the same as that of the standard bur/turbine assembly. In addition, the ProDrive system incorporates the ability to index the bur to a second, extended, position effectively improving on the visibility angle and the utility of the handpiece without adversely affecting its performance. Because of the unique geometry of the ProDrive Replacement Turbine it is appropriate for use only in combination with ProDrive carbide and diamond cutting instruments. Standard round-shank burs will not fit into the ProDrive chuck, preventing their unintended use. ProDrive burs, however, will fit in traditional friction-grip chucks and will meet appropriate performance requirements when used in this way. With the exception of the unique drive-lock spindle, the ProDrive Replacement Turbine consists of commercially available replacement parts currently used to refurbish dental handpieces in the United States. The spindle is composed entirely of stainless steel. The predicate device spindle is also manufactured from stainless steel. Therefore, the products are considered to be identical in materials used in their manufacture. ProDrive burs are composed of tungsten vanadium stainless steel, coated with carbide or diamond cutting surfaces. The ProDrive burs are machined for ProDrive Systems Inc. by the bur manufacturer to the unique shank geometry required by the ProDrive drive-lock mechanism. In all other respects the burs are identical to commercially available burs currently distributed in the United States. The use of stainless steel in the manufacture of ProDrive spindles and burs ensures biocompatibility and resistance to corrosion.
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