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510(k) Data Aggregation
K Number
K243921Device Name
LED Curing Lights (DB686 HALO)
Manufacturer
Foshan COXO Medical Instrument Co., Ltd.
Date Cleared
2025-04-11
(112 days)
Product Code
EBZ
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
Foshan COXO Medical Instrument Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For dental clinics treatment to irradiate polymer-based restorative materials to cure them. The instrument must only be used in hospital environments, clinics or dental offices, by qualified practitioners.
Device Description
The LED Curing Lights (Model: DB686 HALO) is an oral device for repairing teeth. It uses the principle of light curing to make the dental repair resin material solidify rapidly under the action of light wave in the specific wavelength range (385~515nm), so as to fill the tooth cavity or bond the bracket. It is a cordless pen-style device, and consists of handpiece, LED cure tip, charging base, power adapter, eyes protector, eye protector unit and disposable protective sleeve. The LED Curing Lights protects the handpiece and LED cure tip from gross contamination and prevent cross infection between patients by applying the disposable protective sleeve. The disposable protective sleeve (patient contact part) is made of PP material.
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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?
Applicant Name (Manufacturer) :
Foshan COXO Medical Instrument Co., Ltd.
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
K220829Device Name
Endo Motor
Manufacturer
Foshan COXO Medical Instrument Co., Ltd.
Date Cleared
2023-05-18
(422 days)
Product Code
EKX, LQY
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
Foshan COXO Medical Instrument Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
C-SMART-I PRO, C-SMART-I PILOT, C-SMART-MINI AP:
The Endo Motor device is an endodontic treatment motorized handpiece with root canal measurement capability. It can be used to enlarge the canals while monitoring the position of the canal. It can be used as a low-speed motorized handpiece and device for measuring canal length. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.
C-Smart-mini:
The Endo Motor device is an endodontic treatment motorized handpiece. It can be used to enlarge canals. It can be used as a low-speed motorized handpiece. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.
Device Description
C-SMART-I PRO: The Endo Motor device C-SMART-I PRO is a low-speed rotating oral equipment mainly used for root canal preparation and root canal measurement. The product is a portable device powered by built-in lithium batteries and charged by the adapter. LCD displays parameters such as speed, torque, working mode, apex position, etc. Users can also set and modify by keys, and provide design of factory initialization, calibration and functional check of the apex locator. The Endo Motor device is an endodontic treatment motorized handpiece with root canal measurement capability. It can be used to enlarge the canals while monitoring the position of the file tip inside the canal. It can be used as a low-speed motorized handpiece and device for measuring canal length. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel. The Endo Motor device C-SMART-I PRO is intended to be sterilized prior to use. The material composition of root canal files that can be used with the Endo Motor device C-SMART-I PRO is Nickel titanium (NiTi). These files are not included in the submission. There are three working modes as: M1: Apex locator only. M2: Motor only. M3: (Dual mode) Motor with apex location function.
C-SMART-I PILOT: The Endo Motor device C-SMART-I PILOT is a low-speed rotating oral equipment mainly used for root canal preparation and root canal measurement. The product is a portable device powered by built-in lithium batteries and charged by the adapter. LCD displays parameters such as speed, torque, working mode, apex position, etc. Users can also set and modify by keys, and provide design of function check, calibration, factory reset and can connect handpiece to control unit via Bluetooth. The Endo Motor device is an endodontic treatment motorized handpiece with root canal measurement capability. It can be used to enlarge the canals while monitoring the position of the file tip inside the canal. It can be used as a low-speed motorized handpiece and device for measuring canal length. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel. The Endo Motor device C-SMART-I PILOT is intended to be sterilized prior to use. The material composition of root canal files that can be used with the Endo Motor device C-SMART-I PILOT is Nickel titanium (NiTi). These files are not included in the submission. There are three working modes as: Endo motor mode: root canal preparation. Apex locator mode: root canal length measurement. Multi-function mode: undertake root canal measurement and preparation.
C-SMART-MINI AP: The Endo Moto device C-SMART-MINI AP is a low-speed rotating oral equipment mainly used for root canal preparation and root canal measurement. The product is a portable device powered by built-in lithium batteries and charged by the adapter. LCD displays parameters such as speed, torque, apex position, etc. Users can also set and modify by keys, and provide design of functional check, calibration, set dominant hand and factory reset. The Endo Motor device is an endodontic treatment motorized handpiece with root canal measurement capability. It can be used to enlarge the canals while monitoring the position of the file tip inside the canal. It can be used as a low-speed motorized handpiece and device for measuring canal length. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel. The Endo Motor device C-SMART-MINI AP is intended to be sterilized prior to use. The material composition of root canal files that can be used with the Endo Motor device C-SMART-MINI AP is Nickel titanium (NiTi). These files are not included in the submission. There are three working modes as: Endo motor: Prepare the root canal, without apex locator function. Apex Locator: Measure the length of the root canal, without motor function. Multi-function: Measuring the length while root canal preparation.
C-Smart-mini: The Endo Motors device C-Smart-mini is a low-speed rotating oral equipment mainly used for root canal preparation. The product is a portable device powered by built-in lithium batteries and charged by the adapter. LCD displays parameters such as speed, torque, rotary files program, etc. Users can also set and modify by keys, and provide design of calibration and screen display for right- or left-handed user. The Endo Motor device is an endodontic treatment motorized handpiece. It can be used to enlarge the canals. It can be used as a low-speed motorized handpiece. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel. The Endo Motor device C-Smart-mini is intended to be sterilized prior to use. The material composition of root canal files that can be used with the Endo Motor device C-Smart-mini is Nickel titanium (NiTi). These files are not included in the submission.
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K Number
K220826Device Name
LED Curing Light
Manufacturer
Foshan COXO Medical Instrument Co., Ltd.
Date Cleared
2022-12-08
(261 days)
Product Code
EBZ
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
Foshan COXO Medical Instrument Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For light curing polymerization of dental composites, luting materials, cements and other light cured materials.
Device Description
The LED Curing Light is used for light curing polymerization of dental composites, luting materials, cements and other light cured materials. The device is a cordless pen style, LED light polymerization device for use by dental professionals in dental offices or dental laboratories.
The LED Curing Light protect the handpiece from gross contamination and prevent cross infection between patients by applying the single use protective sleeve. The protective sleeve (patient contact part) is made of PP material.
DB686 NANO:
The LED Curing Light DB686 NANO adopts the principle of ray radiation to solidify the light sensitive resin by shooting at it in a short time. It is composed of handpiece, cure tip, battery pack, charging base, adapter and protective sleeve. The handpiece contains the Rotary switch, Indicator light and Start key.
The LED Curing Light DB686 NANO has one mode namely: Curing light mode.
DB686 SWIFT:
The LED Curing Light DB686 SWIFT adopts the principle of ray radiation to solidify the light sensitive resin by shooting at it in a short time. It is composed of handpiece, cure tip, battery, charging base, adapter and protective sleeve. The handpiece contains the Power/Start button, Mode/ Timer button and LED Display.
The LED Curing Light DB686 SWIFT integrates three modes namely: soft up mode, high power mode and orthodontic mode.
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K Number
K220831Device Name
Dental Implantation Systems, Dental Electrical Motors
Manufacturer
Foshan COXO Medical Instrument Co., Ltd.
Date Cleared
2022-09-27
(189 days)
Product Code
EBW, EGS, KMW
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
Foshan COXO Medical Instrument Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
C-Sailor Pro: This device 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. It must only be used in hospital environments, clinics or dental offices by qualified dental personnel.
C-PUMA MASTER: The Dental Electrical Motor is intented 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 the mouth. This device is designed for use by a trained professional in the filed of general dentistry.
Device Description
The proposed device is used to provide the driving force of dental mobile phone for dental surgery. The functions corresponding to the dental operation steps are preset through the host or foot switch, and the electric energy and signal are transmitted to the motor through the motor cable. The motor drives the mobile phone, and the mobile phone drives the dental operation instruments to perform the operation.
The Dental Implantation Systems(C-Sailor Pro) consists of the Foot Control, AC Electrical Cord, Motor (With Cable), Handpiece Stand, Tube Holder, Spare Fuse, Handle (Foot control), and Stand for use with specific Motors. The Dental Electrical Motors(C-PUMA MASTER) consists of the Control Unit, Electrical Motor, Adaptor, Power Cord, Handpiece Stand and Motor Shaft Plug for use with specific Motors.
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K Number
K212178Device Name
Root Apex Locator
Manufacturer
Foshan COXO Medical Instrument Co., Ltd.
Date Cleared
2022-07-20
(373 days)
Product Code
LQY
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Foshan COXO Medical Instrument Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Root Apex Locator is used to detect the apex of root canal. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.
Device Description
The Root Apex Locator C-ROOT I is a oral equipment used for root canal measurement. The device includes a TFT colour display with touch panel displays parameters such as battery status, connection status of test wire and apex position, etc. Users can also set and modify the sound level, brightness level, DR'S CHOICE via a touch panel, and provide a functional check of the device and cable.
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