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510(k) Data Aggregation
K Number
K242179Device Name
Synea Fusion Handpieces (Intensiv & Profin)
Manufacturer
W&H Dentalwerk Bürmoos GmbH
Date Cleared
2025-02-28
(218 days)
Product Code
EFB
Regulation Number
872.4200Why did this record match?
Product Code :
EFB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The reciprocating/oscillating contra-angle handpieces are for the following applications: Preparation, removing protrusions or excess of filling materials and cements, finishing and polishing in the interdental, supragingival and subgingival regions, plaque removal and IPR (interproximal reduction) in orthodontics.
Device Description
W&H's reciprocating/oscillating handpieces were developed as dental contra-angle handpieces that are powered by either an air motor or an electric micromotor. The internally mounted gearing elements transmit the supplied rotational movement up to the head-side assembly holding the clamped tool and generating its reciprocal movement. Because of being designed for two different manufacturers´ files/tips (tools), the following types have been developed: the Synea Profin handpieces WG-67 LT and WG-67 A, intended to be provided with tips/files offered by the Swedish company Dentatus AB (Establishment Reg. No. 8030870) and the Synea Intensiv handpieces WG-68 A, WG-69 LT and WG-69 A (incl. Swiss Edition for WG-69 A and WG-69 LT), intended to be provided with tips/files offered by the Swiss manufacturer Intensiv SA (Establishment Reg. No. 8030958). All these devices´ application is intended in dentistry.
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K Number
K240337Device Name
Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)
Manufacturer
Guangdong JINME Medical Technology Co., Ltd.
Date Cleared
2024-11-13
(282 days)
Product Code
EFB, EGS, KMW
Regulation Number
872.4200Why did this record match?
Product Code :
EFB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For Model J6-126, J6-136:
The Dental Handpiece is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.
For Model SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L:
The Dental Handpiece is intended for cutting and grinding teeth, cavity preparations, tooth and crown preparations, finishing and trimming teeth and filling materials and removal of crowns and filling materials.
Device Description
The Dental Handpiece is mainly composed of a machine head, handle, transmission shaft, and cartridge, and is designed to be attached to the drive via standard coupling which complies with ISO 3964 and hose connector which complies with ISO 9168. The head clamp accepts an instrument complying with ISO 1797-1. The handpieces are intended to be powered by air-powered or electric-powered, and they are also intended to provide optic series. They are intended to be provided non-sterile, so they must be sterilized prior to first use and sterilized after each subsequent use using steam sterilization (moist heat sterilization).
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K Number
K241074Device Name
High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M)
Manufacturer
Foshan SOCO Precision Instrument Co.,Ltd.
Date Cleared
2024-11-12
(207 days)
Product Code
EFB, EGS
Regulation Number
872.4200Why did this record match?
Product Code :
EFB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
High-speed Air Turbine Handpieces: It is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth. Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors: It is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.
Device Description
The proposed device is used to hold rotary instruments such as burs and drills to drive movements to achieve dental operations such as cutting, and drilling. The working principle of the proposed device is that the current and compressed air arrive at the nose through each control valve of the circuit system and air circuit system to drive the motor, turbine (or blade) rotation (shaft core rotation), thus driving the needle rotation to achieve the purpose of drilling and tooth cutting, and the other water and air meet the head to achieve the cooling purpose through each control valve.
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K Number
K241880Device 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
872.4200Why did this record match?
Product Code :
EFB
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
K233122Device Name
High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L)
Manufacturer
Litu Tech Ltd.
Date Cleared
2024-04-30
(216 days)
Product Code
EFB
Regulation Number
872.4200Why did this record match?
Product Code :
EFB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
High Speed Air Turbine Handpiece is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations, root canal preparations and polishing teeth.
Device Description
The proposed devices, High Speed Air Turbine Handpiece, is a dental abrasive device that rotates at high speed air as the driving force. It has 11 models: G100, G200, G300, G400, G450, G500, G600, G700, G700L, G800 and G800L. The cooling system includes air/water spray or only water spray. The head types include standard head and miniature head. The angle of the head and shaft include 45℃ and 90°. High Speed Handpieces are able to run from 320,000rmp to 430,000rmp. G450, G700L and G800L have optic light guide for light function, other models don't have the optic light guide. Coupling is the accessory for the some models of the proposed handpiece to connect with tubes of dental unit.
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K Number
K233308Device 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
872.4200Why did this record match?
Product Code :
EFB
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
K220179Device Name
High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors
Manufacturer
Foshan COXO Medical Instrument Co., Ltd.
Date Cleared
2023-09-22
(609 days)
Product Code
EFB, EGS
Regulation Number
872.4200Why did this record match?
Product Code :
EFB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
High-Speed Air Turbine Handpieces:
It is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.
Straight Handpieces:
It is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.
Geared Angle Handpieces:
It is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.
Air Motors:
It is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.
Device Description
The proposed device is used to hold rotary instruments such as burs and drills for cutting, grinding, and drilling operations. The dental handpieces are hand-held instruments driven by air motor, thus driving the rotation of dental attachments for the purpose of drilling and tooth cutting. Some models include an electric connection to power an LED light
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K Number
K232243Device Name
EVO 700 series high speed handpiece
Manufacturer
Ttbio Corp.
Date Cleared
2023-08-23
(26 days)
Product Code
EFB
Regulation Number
872.4200Why did this record match?
Product Code :
EFB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EVO 700 series High Speed Handpieces are designed for removing carious material, reducing hard tooth structure, cavity preparation and finishing tooth preparations/ restorations. The devices are only for dental handpieces treatment and used by a trained person in the field of dentistry.
Device Description
EVO 700 series high speed handpiece, on the scope of 21 CFR 872.4200 Dental handpiece and accessories, product code EFB, is a modification from TTBIO's own legally market predicate device, EVO 500 series high speed handpiece, which is legally marketed on the US dental market per 510(k) clearance, No. K141183.
EVO 700 series high speed handpiece is air-powered dental handpiece that is reusable and ergonomically designed. The handpiece is connected to a dental tubing which delivers driving air, cooling air and water to the cutting bur area. Optional fiber optics deliver light to the cutting area.
This device is to be connected to dental unit and operated by qualified professional (dentist) in the clinic. EVO 700 series high speed handpiece can be connected to couplings that manufactured by TTBIO, KaVo® or NSK®. It is designed in accordance with FDA Recognized Consensus Standards of device-specific guidance document, ISO 14457:2017 Dentistry - Handpieces and motors to ensure its safety and effectiveness and follows ISO 13485:2016 Medical devices – Quality management systems – Requirements for requlatory purpose regarding to the internal design change control procedure to complete the device design steps.
EVO 700 series high speed handpiece is supplied as non-sterile and can be sterilized by gravity-displacement method, at 132°C for 15 minutes and drying for 30 minutes, and dynamic-air-removal (prevacuum) method, at 134°C for 4 minutes and drying for 15 minutes.
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K Number
K230888Device Name
Titanium Turbine
Manufacturer
Nakanishi Inc.
Date Cleared
2023-06-02
(63 days)
Product Code
EFB
Regulation Number
872.4200Why did this record match?
Product Code :
EFB
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
K221741Device Name
TRAUS Air Dental Handpiece
Manufacturer
Saeshin Precision Co., Ltd.
Date Cleared
2023-02-22
(252 days)
Product Code
EFB
Regulation Number
872.4200Why did this record match?
Product Code :
EFB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This air-powered dental handpiece is intended for removal of carious material, cavities and crown preparations, removal of filings, processing of tooth, restoration of surfaces and as a surgical tool for third molar removal procedures. It is designed for use by a trained professional in the field of general dentistry.
Device Description
The TRAUS Air Dental handpieces are air driven dental handpieces for the use by a trained dental professional. The devices are air-powered handpieces that are reusable and designed accordance with international standard. The devices can be sterilized by the prevacuum steam autoclave methods that have been validated. Through the coupling connected to a dental unit, the proposed dental handpiece receive air for functionality of the high-speed turbine. They also receive cooling water for cutting through one port and light for illumination through another port.
Using in combination with dental unit chair, it is possible to use by installing the instrument at air handpiece according to purpose. It is possible to change the rotation speed by adjusting the flowing air.
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