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510(k) Data Aggregation

    K Number
    K241880
    Device Name
    Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip)
    Manufacturer
    NAKANISHI INC.
    Date Cleared
    2024-09-20

    (84 days)

    Product Code
    EFB
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    NAKANISHI INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Perio-Mate: Perio-Mate is intended for the following application(s): Removal of supragival/subgingival soft deposits and soft deposits on prostheses (including implant abutments). Perio Mate Nozzle Tip: Perio Mate Nozzle Tip is intended for the following application(s): Removal of subgingival soft deposits and soft deposits on prostheses (including implant abutments). The Perio Mate Nozzle Tip and Perio-Mate is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.
    Device Description
    The Air Powered Tooth Polishing System includes the Perio-Mate, which consists of a handpiece and the Perio Mate Nozzle Tip, which is connected to the end of the Perio-Mate handpiece. Perio-Mate is used to remove stains and deposits by spraying the polishing powder and water mixed by compressed air when connected with chair units through couplings or hoses to the treatment area. This device is a non-sterile state and intended to be cleaned and sterilized by end-users as a reusable device. This device to be used for supragingival purpose. During subgingival treatment, Perio Mate Nozzle Tip is connected to the handpiece. The compressed air makes the tooth polishing agent in the Perio-Mate mixed and transfers it to the tip. The product is inserted in a periodontal pocket, sprays the tooth polishing agent/water to the treatment area in the subgingival area, and enables to remove the deposits from teeth surface or prostheses.
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    K Number
    K233288
    Device Name
    NLZ Built-In Motor System
    Manufacturer
    Nakanishi Inc.
    Date Cleared
    2024-06-24

    (269 days)

    Product Code
    EBW
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    Nakanishi Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NLZ Built-in Motor System is indicated for use in the field of prophylaxis dentistry, restorative applications including cavity preparation and endodontic therapy, prosthodontics applications such as crown preparations.
    Device Description
    The NLZ Built-in Motor System is a dental treatment system that is integrated and used in conjunction with dental chair units. It is composed of a motor system, a Multi-Pad, as well as a handpiece (optional) and cord that are compatible with different electric attachments The motor system has a control unit that works as an electric micromotor which can turn on or off and regulates the speed of the electric motor by the foot pedal of the dental unit. This product can be connected to dental units currently in use to add on a brushless electric micromotor with an LED light. Depending on the specifications of each chair unit manufacturers, the combination and operation method of the NLZ Built-in Motor System board, harness, and operation method will change.
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    K Number
    K233117
    Device Name
    Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)
    Manufacturer
    Nakanishi Inc.
    Date Cleared
    2024-06-20

    (267 days)

    Product Code
    EBW
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    Nakanishi Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Surgic Pro2 is intended for use in dental oral surgery and dental implant. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard tissues in the mouth.
    Device Description
    The Surgic Pro2 consists of the Control Unit, the Foot Control, Motor and accessories. The Control Unit drives the Motors during procedures and is used to control the functions related to the Motor such as rotational direction. The Foot Control provides the user with "hands-free" control of the coolant flow, program selection, forward/reverse rotational direction, and speed during operation. Two models of the Motor with Motor cord are available, SGL80M Optic Motor. The SGL80M Optic Motor contains LED illumination of over 32,000 LUX. Each Motor is included with each series set in accordance to the client's specific needs and requirements. The Surgic Pro2 is intended for use in dental implant. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard tissues in the mouth. Features of this product are Bluetooth connectivity with a Foot Control, "Osseo 100+" ISQ measurement device *, and other company's products "iPad". The ISQ values measured by the "can be displayed on the Surgic Pro2 control unit. The "iPad" can display information on the control unit including ISQ values on the dedicated application for Surgic Pro2. The displayed information can be stored in the iPad. * The ISQ value is measured by the Osseo100+ and the ISQ value displayed on the display of the SurgicPro2 connected via Bluetooth. The product is provided unsterilized, and the motors are washed and sterilized at a medical institution, and used repeatedly. The product has no bio-contact components.
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    K Number
    K233308
    Device Name
    Air Motor (Model name: FX204 M4); Air Motor (Model name: M205)
    Manufacturer
    NAKANISHI INC.
    Date Cleared
    2024-04-25

    (209 days)

    Product Code
    EFB
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    NAKANISHI INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Air Motor is intended for the following application(s): Driving the handpiece for the tooth restoration, prophylaxis, and root canal preparation.
    Device Description
    The air motor converts the compressed air supplied from the dental unit into rotary motion. The rotation is transmitted to instruments for tooth restoration, prophylaxis, and root canal preparation connected to straight and geared angle handpieces.
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    K Number
    K230888
    Device Name
    Titanium Turbine
    Manufacturer
    Nakanishi Inc.
    Date Cleared
    2023-06-02

    (63 days)

    Product Code
    EFB
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    Nakanishi Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Titanium Turbine is intended for the following applications: Caries removal, Cavity and crown preparation, Removal of dental restorations (fillings and prostheses), Finishing of teeth and dental restorations (preparation/adjustment).
    Device Description
    The Titanium Turbine is an air-driven dental handpiece used by qualified dental professionals. The Titanium Turbine is connected to a dental unit via a coupling and uses supplied compressed air to rotate a dental bar attached to its tip at a high speed (380.000-450.000 min-') to enable dental treatment. Titanium Turbine is mainly made of titanium and can be reused by reprocessing. This device is equipped with a Clean Head System that reduces suck-buck into the head and exhaust line, thereby reducing cross-contamination of the air lines. Titanium Turbine is also equipped with a quick stop system that reduces the time required to stop rotation, thereby improving oral cavity safety, and reducing suck-buck.
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    K Number
    K230106
    Device Name
    General Cutting Straight
    Manufacturer
    Nakanishi Inc.
    Date Cleared
    2023-05-24

    (131 days)

    Product Code
    EGS
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    Nakanishi Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    X65L / X65 / M65 General Cutting Straight is intended for the following application(s): Caries removal, cavity and crown preparation, removal of dental restorations (fillings and prostheses), finishing and polishing of teeth and dental restorations. FX65 / FX65m / EX-5B General Cutting Straight is intended for the following application(s): Caries removal, cavity and crown preparation, removal of dental restorations (fillings and prostheses), finishing and polishing of teeth and dental restorations. Using a prophy angle, prophylaxis treatment of the surface of teeth and dental restorations.
    Device Description
    The General Cutting Straight is a prescription-only dental straight handpiece used by qualified dental healthcare professionals in general dentistry. The General Cutting Straight includes six models: X65L, X65, M65, FX65m, FX65, and EX-5B. The General Cutting Straight conforms to ISO 14457 and is driven by an ISO 3964-compliant electric or air motor. The General Cutting Straight achieves its intended use in conjunction with an ISO 1797-compliant rotary instrument or a prophy angle that conforms to either ANSI ADA Standard No. 85-2004 (R2009) or ISO 14457. The General Cutting Straight is composed mainly of stainless steel, titanium, or aluminum, depending on the model, and is reusable, requiring cleaning and steam sterilization. The accessories of the General Cutting Straight include the Bur Stopper, Bur Stopper Puller, and E-Type Spray Nozzle. The General Cutting Straight is lubricated with the PANA SPRAY Plus [K163486] using the E-Type Spray Nozzle.
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    K Number
    K222518
    Device Name
    FX Contra
    Manufacturer
    Nakanishi INC.
    Date Cleared
    2022-11-17

    (90 days)

    Product Code
    EGS
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    Nakanishi INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FX15 / FX15m / FX25 / FX25m FX Contra is intended for the following application(s): Caries removal, cavity and crown preparation, removal of dental restorations (fillings and prostheses), finishing and polishing of teeth and dental restorations. FX57 / FX57m FX Contra is intended for the following application(s): Prophylaxis treatment of the surface of teeth and dental restorations.
    Device Description
    The FX Contra includes six models: FX15, FX15m, FX25, FX25m, FX57, and FX57m. The FX Contra handpieces are reusable contra-angle handpieces, driven by an ISO 3964 compliant electronic micromotor or air motor, that are intended for use in a healthcare facility/hospital setting by a trained health care professional in the field of general dentistry. The FX Contra handpieces are designed for general applications to prepare dental cavities for restorations (FX15/FX15m/FX25/FX25m) and for prophylactic teeth cleaning (FX57/FX57m). The FX Contra handpieces feature ISO 3964 compliant handpiece coupling connecting them to a dental unit through either a micromotor or an air motor. By these means the handpieces receive the energy for the gear for dental treatment. The maximum drive speed is 40,000 min-1 for FX15, FX15m, FX25, and FX25m; and 20,000 min-1 for FX57 and FX57m. The maximum rotation speed is 10,000 min-1 for FX15 and FX15m; 40,000 min-1 for FX25 and FX25m; and 5,000 min-1 for FX57 and FX57m. The FX Contra handpieces are composed mainly of stainless steel and aluminum and can be sterilized in a steam sterilizer (autoclave).
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    K Number
    K203791
    Device Name
    Stainless Turbine
    Manufacturer
    NAKANISHI INC.
    Date Cleared
    2022-06-21

    (540 days)

    Product Code
    EFB
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    NAKANISHI INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stainless Turbine is intended for the following applications: Caries removal, Cavity and crown preparation, Removal of dental restorations (fillings and prostheses), Finishing of teeth and dental restorations (preparation/adjustment). The coupling is intended for the following applications: A connection device to transfer energy (air, water, light) required for handpieces.
    Device Description
    The Stainless Turbine handpieces are air driven dental handpieces for use by a trained professional in the field of general dentistry. The handpieces are air-powered, high-speed dental handpieces capable of reaching rotational speeds of 325,000 to 450,000 revolutions per minute. Handpiece models include fiber optic, LED, and non-optic lighting. The handpiece models are available to connect directly to NAKANISHI INC. manufactured couplings. Available handpiece models include the S-Max M Series, Pana-Max Plus Series, Pana-Max Plus2 Series, and the S-Max pico Series. The Stainless Turbine couplings are connection devices used to attach the dental unit to the Stainless Turbine handpieces. Available coupling models include the Glass Fiber Rod Series, LED Series, and No Light Irradiation Series.
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    K Number
    K202120
    Device Name
    P300 Attachment
    Manufacturer
    Nakanishi Inc.
    Date Cleared
    2021-10-22

    (449 days)

    Product Code
    HBE, ERL, HWE
    Regulation Number
    882.4310
    Why did this record match?
    Applicant Name (Manufacturer) :

    Nakanishi Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The P300 Attachment is intended to be used with electric and pneumatic surgical instruments and cutting accessories for cutting, drilling, removal, and shaping of bone in the procedures of: Neuro, Spine, Orthopedic, and General Surgery. NSK Sterile Cutting Accessory(ies) is for single use only. This device is intended for use, in conjunction with P300 Attachment, in cutting, drilling, removal, and shaping of bone in the procedures of: Neuro, Spine, Orthopedic, ENT, Maxillofacial, and General Surgery.
    Device Description
    The P300 Attachment is a powered bone cutting and drilling instruments designed to be used with the Primado2 Total Surgical System (K132264), which provides mechanical power to the attachment. The P300 Attachment is comprised of two families: Standard Attachment 300 and Slim Attachment 300. The Standard Attachment 300 and Slim Attachment 300 consist of angled and straight types of attachments with varying lengths. The Standard Attachment 300 is an attachment to the Primado2 Total Surgical System that can be in either a straight or angled configuration and comes in 5 different tube lengths, ranging from 12 mm to 79 mm. Accessories compatible with the Standard Attachment 300 include 52 NSK Sterile Cutting Accessories, a STD Attachment Beak, and 4 Irrigation Nozzles. The Slim Attachment 300 consists of 2 parts, a Slim Attachment Hub that comes in 2 configurations (straight or angled) and a Slim Tube that comes in 8 configurations and varies in tube lengths from 110 mm to 240 mm, and can be straight, curved, or angled. Accessories compatible with the Slim Attachment 300 include 49 NSK Sterile Cutting Accessories, a Slim Tube Beak and a Slim Tube Hood, and 2 Irrigation Nozzles. The Standard Attachment 300 and Slim Attachment 300 share the same Cleaning Tools for automated cleaning, manual cleaning, and purging. For both the Standard Attachment 300 and the Slim Attachment 300, the length of the bur can be adjusted in six levels. Both the Standard and Slim attachments include a non-slip surface etching on the grip. The attachments consist of stainless steel, polytetrafluoroethylene, Copper-Beryllium Alloy, fluorocarbon rubber, and PEEK.
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    K Number
    K211584
    Device Name
    Oral Surgery Contra
    Manufacturer
    Nakanishi INC.
    Date Cleared
    2021-08-19

    (87 days)

    Product Code
    KMW, EBW
    Regulation Number
    872.4120
    Why did this record match?
    Applicant Name (Manufacturer) :

    Nakanishi INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Oral Surgery Contra is for oral surgery. This device is driven by an electronic micromotor for oral surgery and dental implant. This device aims to transfer the rotation of the power source with various gear ratios, and moves instruments such as a surgical bur to cut the maxillary/mandibular bone during oral surgery treatment.
    Device Description
    The Ti-Max Series Oral Surgery Contra handpieces, X-SG93L, X-SG93 and X-SG25L, are contra-angle handpieces that are intended for use by a clinician in a healthcare facility/hospital setting for oral surgery and preparation for dental implant operation. The subject handpieces are available in two options: 1) fiber optic glass (X-SG93L and X-SG25L) or 2) non-optic (X-SG93). The Oral Surgery Contra handpieces are driven by a micromotor, thereby rotating surgical burs at different transmission gear ratios, to cut the maxillary/mandibular bone during oral surgery and preparation for dental implant surgery. The maximum rotational speeds of the handpieces are as follows: 120,000 min-1 for the X-SG93L and X-SG93 models; 40,000 min-1 for the X-SG25L model. The maximum rotation speed depends on the transmission gear ratios as follows: Model | Transmission gear ratio | Maximum speed ---------|-------------------------|--------------- X-SG93L | 1:3 Increasing | 120,000 min-1 X-SG93 | 1:3 Increasing | 120,000 min-1 X-SG25L | 1:1 Direct Drive | 40,000 min-1 The handpieces are manufactured using titanium and stainless steel and feature a push-button chuck mechanism. They are designed for use with surgical motors with an ISO 3964 (EN ISO 3964) type coupling system. The handpieces are designed for use with surgical burs, as follows: - X-SG93L and X-SG93: ISO 1797 Type 3 FG burs (φ1.59 - 1.6 mm) - X-SG25L: ISO 1797 Type 1 CA burs (φ2.334 - 2.35 mm). The Oral Surgery Contra handpieces are a prescription-only device.
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