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Found 13 results
510(k) Data Aggregation
K Number
K991701Device Name
MACH-SIGMA HANDPIECE, ULTRAPUSH, MODELS MACH-SIGMA MU (MINI HEAD), MACH-SIGMA SU (STD. HEAD), MACH-SIGMA TU (TORQUE HD)
Manufacturer
NSK NAKANISHI, INC.
Date Cleared
1999-08-10
(83 days)
Product Code
EFB
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
NSK NAKANISHI, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is intended for use in general dental applications, where high speed cutting is required, such as cutting a tooth for crown preparation, cavity preparation, removing metal crown or fillings. In addition to above Indication for Use, we would like to emphasize, as a USA-patented, long proven dust shield mechanism, Clean-Head System, is used as an integral part of the turbine cartridge, that this device is able to substantially reduce bacterial contamination of the handpiece exhaust air lines to the dental unit.
Device Description
Air Turbine Handpiece, Mach-Sigma Ultra Push
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K Number
K991021Device Name
SONIC SCALER WITH FIBER OPTIC, MODEL NAS-L, SONIC SCALER WITHOUT FIBER OPTIC, MODEL NAS-NL
Manufacturer
NSK NAKANISHI, INC.
Date Cleared
1999-06-23
(86 days)
Product Code
ELC
Regulation Number
872.4850Why did this record match?
Applicant Name (Manufacturer) :
NSK NAKANISHI, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device, an air-powered, fiber optic, swivel air scaler, is intended for use to remove calculus deposits and stains from a tooth, as done in normal dental scaling operation . The device uses controlled water spray and an appropriate scaling tip to wash away removed calculus and stains.
Device Description
air-powered, fiber optic, swivel air scaler
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K Number
K990954Device Name
ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET
Manufacturer
NSK NAKANISHI, INC.
Date Cleared
1999-06-09
(79 days)
Product Code
EBW
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
NSK NAKANISHI, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is a control unit that drives a dc electric micromotor and turns on or off the motor by its foot switch. It is intended for use in general dental applications for work such as cutting a tooth for crown preparation, cavity preparation, finishing the crown, inlay or the filling, polishing, prophylaxis and endodontic treatment, with use of a straight, right-angle or contra-angle ISO E-type attachment of equal speed, speed increasing or decreasing sheath. The micromotor speed is adjustable by the control knob on the front face of the control unit from 2,000 to 30,000 rpm.
Device Description
The device is a control unit that drives a dc electric micromotor and turns on or off the motor by its foot switch. The micromotor speed is adjustable by the control knob on the front face of the control unit from 2,000 to 30,000 rpm.
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K Number
K990682Device Name
PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), ENDO-MATE (600RPM MAX.)
Manufacturer
NSK NAKANISHI, INC.
Date Cleared
1999-03-24
(21 days)
Product Code
EKX
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
NSK NAKANISHI, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device, a small, battery-powered, light-weight, low-speed electric motor handpiece, runs at 200 rpm to 2000 rpm, and is intended for use in light general dental, prophylaxis, or endodontic works, where low speed is required.
Device Description
a small, battery-powered, light-weight, low-speed electric motor handpiece, runs at 200 rpm to 2000 rpm. A variety of detachable heads, each of which is pushed into or pulled out of the motor handpiece, are available to perform required job, such as a prophy head for screw-in or snap-on prophy cups and brushes, a latch head for latch reamer or latch file, a 1/4-turn head, up-down head, 10:1 reduction speed head, etc.
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K Number
K990646Device Name
PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATE
Manufacturer
NSK NAKANISHI, INC.
Date Cleared
1999-03-19
(18 days)
Product Code
EKX
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
NSK NAKANISHI, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is a dc electric micromotor driven by the battery power pack control device with emphasis in mobility to visit schools, nursing homes, house calls, and for emergency need.
It is intended for use in general dental applications for light work such as cutting a tooth for crown preparation, cavity preparation, finishing the crown, inlay or the filling, polishing, and endodontic treatment, with use of straight, right-angle or contra-angle ISO E-type attachment.
Device Description
The device is a dc electric micromotor driven by the battery power pack control device with emphasis in mobility to visit schools, nursing homes, house calls, and for emergency need.
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K Number
K980162Device Name
MACH-SIGMA HANDPIECE, ULTRAPUSH
Manufacturer
NSK NAKANISHI, INC.
Date Cleared
1998-06-05
(140 days)
Product Code
EFB
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
NSK NAKANISHI, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is intended for use in general dental applications, where high speed cutting is required; such as cutting a tooth for crown preparation, cavity preparation, removing metal crown or fillings.
This device uses a USA-patented, long proven check valve, a Non-Retraction Valve, in the water line of the handpiece to prevent the oral fluids, which could be contaminated, from being drawn into the handpiece spray port(s) of the handpiece. The contaminants could reach beyond the handpiece, but this check valve, as being installed in the handpiece body, prevents them from reaching beyond the handpiece.
Device Description
Air Turbine Handpiece, MACH-Sigma (Σ) Ultra-Push
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K Number
K972924Device Name
SURGIC II IMPLANT CONTROL UNIT
Manufacturer
NSK NAKANISHI, INC.
Date Cleared
1997-10-30
(83 days)
Product Code
EBW
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
NSK NAKANISHI, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is a control unit intended to drive contra angles and other attachments that are used with appropriate burs and drills for drilling, reaming, decorticating, and smoothing of bone and other bone related tissue in a variety of dental, oral surgical and other small surgical procedures.
Device Description
The device is a control unit intended to drive contra angles and other attachments that are used with appropriate burs and drills for drilling, reaming, decorticating, and smoothing of bone and other bone related tissue in a variety of dental, oral surgical and other small surgical procedures. The control unit is equipped with a roller pump to deliver saline solution or sterile water as irrigant to the handpiece. The electric micromotor and its cord are not autoclavable; therefore, adequate covering by plastic sleeving as commonly used in dental for infection control method is necessary. The irrigation tube set used between the irrigation nozzle at the handpiece and the saline solution bottle via roller pump is supplied as an accessory item in the control unit package. It is ETO sterilized for 10 ° sterility, pyrogen-free. The control unit has risk of explosion if used in the presence of flammable anesthetics.
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K Number
K972569Device Name
E-TYPE SPEED INCREASER CONTRA ANGLE, EXTERNAL IRRIGATION, INTERNAL IRRIGATION
Manufacturer
NSK NAKANISHI, INC.
Date Cleared
1997-10-08
(90 days)
Product Code
EGS
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
NSK NAKANISHI, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is intended for use where high speed such as 200,000 rpm is required in general dentistry with or without use of coolant; such as cutting a tooth for cavity and/or crown preparation and finishing, cutting and/or finishing of dentures, denture bases, crowns, inlays and metal plates. The device is driven by an electric micromotor or an air motor handpiece that has the ISO-3964 Coupling.
Device Description
E-Type Speed Increaser Contra Angle, ES-95
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K Number
K971774Device Name
NSK PUSH-BUTTON MIDWEST REPLACEMENT TURBINE:FOR QUIETAIR AND TRADITION
Manufacturer
NSK NAKANISHI, INC.
Date Cleared
1997-06-20
(38 days)
Product Code
EFB
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
NSK NAKANISHI, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The devices claimed hereis are the air turbines only, and are not the handpiece itself.
The devices are intended for use in the Miwest's Quiet-Air or Tradition handpieces, in place of Midwest's original turbines.
The device, therefore, is, with Midwest handpiece, intended for use in general dental applications; such as cutting a tooth for crown preparation, cavity preparation, finishing the crown, inlay or the filling, etc.
Device Description
NSK Pushbutoon Autochuck Replacement Turbine. The devices claimed hereis are the air turbines only, and are not the handpiece itself.
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K Number
K970953Device Name
E-TYPE SPEED REDUCER CONTRA ANGLE
Manufacturer
NSK NAKANISHI, INC.
Date Cleared
1997-04-15
(29 days)
Product Code
KMW
Regulation Number
872.4120Why did this record match?
Applicant Name (Manufacturer) :
NSK NAKANISHI, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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