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510(k) Data Aggregation
K Number
K222569Device Name
Ai Ray Dental X-Ray Device
Manufacturer
Guilin Woodpecker Medical Instrument Co., Ltd.
Date Cleared
2022-11-23
(91 days)
Product Code
EHD
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
Guilin Woodpecker Medical Instrument Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Ai Ray Dental X-Ray Device is an extraoral diagnostic dental X-ray source to produce X-ray images using intraoral image receptors. It is indicated for use by a dental technician for both adult and pediatric patients.
Device Description
Ai Ray Dental X-Ray Device is a super capacitor-operated, portable dental X-ray source designed for handheld operation. It is designed to produce diagnostic quality X-rays images utilizing either film or digital imaging techniques. The Portable Dental X-ray Device is designed for use in a dental office. It can also be used in other similar environments (orthodontic office, general practitioner's office, hospital ward, etc.) where appropriate safeguards are implemented. The device uses a rechargeable supercapacitor to allow for the use of the Portable Dental X-ray Device where transportation or use of other x-ray devices might be prohibitive due to the other device's size and/or lack of mobility.
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K Number
K211358Device Name
Implanter incl. Accessories
Manufacturer
Guilin Woodpecker Medical Instrument Co., Ltd.
Date Cleared
2022-11-21
(567 days)
Product Code
EBW
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
Guilin Woodpecker Medical Instrument Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Mechanical drive unit with coolant supply for transmission instruments with ISO 3964 (DIN13940) compatible coupling system, for use in dental surgery, implantology and maxillofacial surgery (CMF) for treatment of dental hard tissue.
Device Description
The Implanter is intended for use in dental surgery, implantology and maxillofacial surgery (CMF) for treatment of dental hard tissue. The submission consists of: - the control unit - a motor with cable with light (sterilizable: SPM58L) - a wired foot control (MF4) - and as an attachment the surgical contra-angle handpieces (with LED:WP-1L/without LED:WP-1). Eight different programs can be selected by the user. Switching between these programs is performed by foot control or via touch display. The programs include Positioning, Hole-drilling, Hole-Broadening, Tapping, Implanting, Lock the Abutment Screw, User Defined Mode and Cleaning. The control unit is intended to be used with the motor SPM58L. To run the Implanter according to its intended use, Guilin Woodpecker provides two different surgical handpieces.
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K Number
K221548Device Name
Dental Air Polishing Handpiece
Manufacturer
Guilin Woodpecker Medical Instrument Co., Ltd.
Date Cleared
2022-09-28
(124 days)
Product Code
EFB
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
Guilin Woodpecker Medical Instrument Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Dental Air Polishing Handpiece, AP-H Plus is a dental handpiece intended for use in the cleaning and polishing of teeth by the projection of a mixture of water, air, and powder onto the tooth surface. The device removes soft deposits and areas of discoloration and can be used to prepare teeth for dental procedures such as the placement of composite fillings, porcelain inlays, and laminate veneers. The device can be used to clean implant abutments and to clean teeth prior to treatments such as shade matching, fluoridation, and bleaching. The device can also be used to degrease crowns and bridges prior to placement and clean fixed bands and brackets on orthodontic appliances.
The Dental Air Polishing Handpiece, AP-H Plus is intended for patients suffering from periodontal disease.
The Dental Air Polishing Handpiece, AP-H Plus is indicated for the non-surgical removal of subgingival plaque in pockets up to 4 mm after initial periodontal treatment.
Device Description
The Dental Air Polishing Handpiece, AP-H Plus is an air driven dental handpiece for the use by a trained professional in the field of supragingival and the subgingival treatment. The devices are air-powered handpieces that are reusable.
The proposed Dental Air Polishing Handpiece, AP-H Plus device is similar in design to the predicates AIR-FLOW handy 3.0 PLUS (K151912) . The proposed Dental Air Polishing Handpiece, AP-H Plus device and the predicates connect to a standard air turbine connection on a dental operative unit and deliver a mixture of water, air, and prophylaxis powder to a treatment site. The subject Dental Air Polishing Handpiece is comprised of a supragingival handpiece (model: AP - 1 Plus) a subgingival handpiece (model: AP - 2 Plus), spray head, nozzle, powder storage chamber, and tail cord connector.
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K Number
K210367Device Name
D-Laser Blue, D-Laser 16
Manufacturer
Guilin Woodpecker Medical Instrument Co., Ltd.
Date Cleared
2022-03-10
(395 days)
Product Code
NVK, GEX, ILY
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Guilin Woodpecker Medical Instrument Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
D-Laser Blue and D-Laser 16 are intended for intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue including marginal and epithelial lining of free gingiva and are indicated for: frenectomy; frenotomy; implant recovery; gingivectomy; gingivectomy; gingivoplasty; gingival troughing; crown lengthening; hemostasis of donor site; removal of granulation tissue; laser assisted flap surgery; debridement of diseased epithelial lining: incisions and draining of abscesses: tissue retraction for impressions: papillectory; vestibuloplasty ; excision of lesions; exposure of unerupted/partially erupted teeth; removal of hyperplastic tissues; treatment of aphthous ulcers; leukoplakia; laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket, sulcular debridement (removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss and tooth inability); pulpotomy; pulpotomy as adjunct to root canal therapy; fibroma removal; gingival incision and excision; treatment of canker sores; herpetic ulcers of the oral mucosa; laser soft tissue curettage; reduction of gingival hypertrophy.
Whitening: D-Laser Blue and D-Laser 16 are indicated for light activation for bleaching materials for teeth whitening and for laser-assisted whitening/bleaching of teeth.
Low Level Laser Therapy: D-Laser Blue and D-Laser 16 are intended to emit energy in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, and for the temporary increase in local blood circulation and/or temporary relaxation of muscles.
Device Description
The dental diode laser systems, D-Laser Blue and D-Laser 16, realize oral soft tissue surgery, periodontal disease, endodontic disease, pain treatment, soft laser therapy and other oral diseases by vaporizing, carbonizing and solidifying the tissue by laser. The device features include: Using a capacitive touch screen which has the clear display and is easy to operate; Builtin large-capacity rechargeable lithium battery with longer time of endurance; The handpiece sleeve and the fiber tip can be autoclaved to prevent from cross infection; Preset more than 20 treatment procedures to reduce the difficulty of use; A secure protection mechanism that automatically shuts down the device after 5 minutes of inactivity.
The D-Laser Blue and the D-Laser 16 respectively consist of a main unit, a laser transmission system and a power adapter. The main unit includes a semiconductor laser, a power supply system and a control device, a safety protection device and a display device.
The D-Laser Blue employs the diodes with wavelengths of 976nm, 650nm and 450nm, and the device emits laser output energy in the infrared, red and blue spectra respectively. The D-Laser 16 employs the diodes with wavelengths of 976nm and 650nm, and the device emits laser output energy in the infrared, red spectra respectively.
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K Number
K203706Device Name
Dental Electric Motor
Manufacturer
Guilin Woodpecker Medical Instrument Co., Ltd.
Date Cleared
2022-01-13
(391 days)
Product Code
EBW, EGS
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
Guilin Woodpecker Medical Instrument Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MT2 dental electric motor consists of main unit, motor tail, power adapter and power cord. It is intended for use in general dental applications such as: cutting a tooth for cavity preparation, crown finishing, inlay, filing, polishing, prophylaxis and endodontic treatment. The Dental Electric Motor can be used with ISO E-type a straight, right-angle or contra-angle handpiece attachment of equal, gear-reducing, or gear increasing speed.
The contra-angle handpieces (model: WJ-15, WJ-15L) are driven by a micro-motor to rotate at a specified speed, so as to drive the dental bur. It is applicable to drilling and grinding in dental surgery.
Device Description
The MT2 dental electric motor consists of main unit, motor, motor tail, power adapter and power cord. It is intended for use in general dental applications such as: cutting a tooth for cavity preparation, crown preparation, crown finishing, inlay, filing, polishing, prophylaxis and endodontic treatment, with use of a straight, rightangle or contra-angle handpiece attachment of equal, gear-reducing, or gear increasing speed.
Dental Electric Motor (model: MT2) is a control unit, which is connected to an AC power supply and a handpiece hose, that drives a DC electric micromotor, and turns on or off or regulates the speed of the motor by the foot control of the dental unit. The foot switch is not included in the control unit. It is used together with a handpiece attachment. It provides a low voltage DC power supply for the handpiece attachment with light.
The device is for prescription use.
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K Number
K211531Device Name
Cordless Prophy System, Model: i-Polish
Manufacturer
Guilin Woodpecker Medical Instrument Co., Ltd.
Date Cleared
2021-12-17
(214 days)
Product Code
EKX
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
Guilin Woodpecker Medical Instrument Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
i-Polish is a cordless prophylaxis handpiece equipped with control buttons and wireless foot control for use with disposable prophylaxis angles in hygiene operatory to perform cleaning and polishing procedures on teeth surface and fillings.
Device Description
The Cordless Prophy system is a cordless handpiece which is intended for use by dental professionals for cleaning and polishing teeth. This is a general hygiene procedure that is performed on people of all ages in a professional dental operatory.
The Cordless Prophy System is comprised of a cordless, battery-powered handpiece, a removable and autoclavable outer sheath, an AC powered battery charging station, a battery-powered wireless foot control and an AC adapter. Accessories to the Cordless Prophy System include three style of Disposable Prophy Angle (DPA), which is cleared as Class I, Product code ESG, under premarket notification K030603.
Additionally, the handpiece of Cordless Prophy System must be used with a Disposable Sleeve, which is cleared as Class II, Product Code PEM, under premarket notification K151123.
The handpiece features a removable outer sheath that is to be cleaned and steam sterilized prior to first use and after each patient use.
The i-Polish has two speed control mode for operation:
- . Foot control mode: One is using it with the wireless foot control, where the amount of vertical actuation on the wireless foot control correlates to the speed of the handpieces supplied to the DPA, the corresponding variable speed range of the DPA is controlled and adjusted through varying pressure on the foot control. The adjustable range is 500 rpm to 4000 rpm;
- . Handpiece control mode: And the other uses a Centralized control button located on the handpieces for six constant speed level, 500 rpm, 1500 rpm, 1500 rpm, 2000 rpm, 3000 rpm and 4000 rpm.
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K Number
K203615Device Name
Dental Scaler and Air Polisher
Manufacturer
Guilin Woodpecker Medical Instrument Co., Ltd.
Date Cleared
2021-12-10
(365 days)
Product Code
ELC, KOJ
Regulation Number
872.4850Why did this record match?
Applicant Name (Manufacturer) :
Guilin Woodpecker Medical Instrument Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The dental scaler and air polisher, Model PT-A, is intended for use in dental (gum) therapy and polishing. The device polishes the teeth and removes calculus deposits and stains from pits, grooves, interproximal spaces, or smooth surfaces of teeth. By attaching the ultrasonic handpiece with different scaling tips, the device could fulfill the following functions: 1 Scaling Removal of supragingival calculus; Removal of stains 2 Endo Preparation, cleaning and irrigation of root canals: Retrograde preparation of root canals Condensing gutta-percha; Removal of crown, bridges and restorations 3 Restorative - Cavity preparation; Luting inlays and onlays; Condensing of amalgams 4 Perio Scaling and root planing; Periodontal treatments By using air polishing handpiece attached with corresponding nozzles, the device could fulfill the following functions - · Removing dental plaque - · Surface preparation before bonding/cementation of inlays, crowns and veneers - · Tooth surface preparation before placing the composite restoration - · Cleaning before sticking orthodontic brackets - · Effectively removing plaque for orthodontic patients - · Cleaning the implant fixture before loading - · Stain removal for shade determination - · Removing plaque before fluoride treatment - · Removing plaque before whitening procedure
Device Description
The dental scaler and air polisher, Model PT-A, mainly consists of ultrasound scaler system and air polishing system. More specifically, it mainly contains a control module, a display panel with function keys, water bottle, powder tank, scaling handpiece, air polishing handpiece, scaling tips, sand blasting nozzle, foot pedal and power adapter. The device generates ultrasonic waves intended for dental applications such as scaling, root canal irrigation and periodontal preparation. For the ultrasonic system, a sinusoidal electrical signal is generated and delivered to the 'piezoelectric ceramic' located inside the ultrasonic handpiece. The electrical signal is converted into mechanical vibrations and propagated to the distal end of the handpiece. For air polishing system, the powder tank is driven by air pressure to flow into the nozzle attached with the air polishing handpiece and mixed with air and water to blast the teeth. By attaching the ultrasonic handpiece with appropriate scaling tips, the device could fulfill scaling, restorative, endodontal treatment. However, by attaching the corresponding nozzle to the air polishing handpiece, the device could remove calculus, stains, plaques and polish the teeth. The device is powered by a power adapter with input of 110V~ 50Hz/60Hz 800mA and output of 25V~ 50Hz/60Hz 2.8A. The ultrasonic handpiece, air polishing handpiece with or without non-disposal stainless steel sand blasting nozzles, and scaling tip are provided non-sterile, which will be sterilized by the user before use.
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K Number
K212080Device Name
Imaging Plate Scanner, i-Scan
Manufacturer
Guilin Woodpecker Medical Instrument Co., Ltd.
Date Cleared
2021-09-27
(87 days)
Product Code
MUH
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
Guilin Woodpecker Medical Instrument Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
i-Scan Imaging Plate Scanner is intended to be used for scanning and processing digital images exposed on IP Imaging Plate in dental applications.
Device Description
i-Scan Imaging Plate Scanner is a dental device that scans IP imaging plates that have been exposed in place of dental X-ray film and allows the resulting images to be displayed on a personal computer and stored for later recovery. It will be used by licensed clinicians and authorized technicians for this purpose. The device is an intraoral Plate Scanner, which is designed to read out intraoral Plates of the size 0, 1, 2 and 3. Intraoral plate scanners are state of the art since 2002 and are available in various designs from many companies around the world. The intraoral plates are put into the mouth of the patient, exposed to Xrays and then are read out with the device. The read-out-process is carried out with 651-665 nm laser. The laser beam is moved across the plate by an oscillating MEMS mirror. The laser beam stimulates the top coating of the plates, which consists of Xray sensitive material. Depending on the exposed dose, the coating emits different levels of light. These light particles are then requisitioned by an optical sensor (Photo Multiplier Tube/ PMT) and transferred into an electrical output signal is digitalized and is the data for the digital X-ray image. The data is transmitted via WIFI to a computer. Before the plate is discharged, the remaining data is erased by a LED-PCB. The user chooses which size of plate he must use and prepares the device by inserting the appropriate plate insert into the device. He then exposes the plate and then puts the plate directly into the insert by pushing it out of the light protection envelope. The user closes the light protection over and starts the read-out process. After the read out process the picture is transmitted to the connected computer, the picture can be viewed, and the IP is erased and ready to use for the next acquisition.
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K Number
K203320Device Name
Endo Motor
Manufacturer
Guilin Woodpecker Medical Instrument Co., Ltd.
Date Cleared
2021-05-10
(179 days)
Product Code
EKX
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
Guilin Woodpecker Medical Instrument Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Endo Motor, Ai-Motor and Endo Radar Plus are cordless endodontic treatment motorized handpiece with root canal measurement capability. It can be used for preparation and enlargement of root canals, or measuring the canal length. And it can be used to enlarge the canals while monitoring the file tip inside the canal.
Device Description
The Endo Motor Series includes a cordless hand-piece with charging adapter. The device has a chuck for holding rotary instruments such as dental files, and is mainly used in Endodontic surgeries. The device can enlarge the root canal by filing the dentin and measuring the root canal length, and may also be used for cutting and grinding for the preparation of root canal surgery. The rotary speed and the torque range can also be adjusted.
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K Number
K181087Device Name
Apex Locator, DPEX III
Manufacturer
Guilin Woodpecker Medical Instrument Co., Ltd.
Date Cleared
2018-12-18
(237 days)
Product Code
LQY
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Guilin Woodpecker Medical Instrument Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Apex Locator, DPEX III is a microprocessor controlled device intended for locating the apex of root canal.
Device Description
Apex Locator, DPEX III is an apex locator intended for precise localization of root canal apex. Operation of Apex Locator, DPEX III is fully automatic, no manual calibrations or adjustments are required. The measuring signal is analyzed, and automatic adjustments are made if needed. The device may operate within different conditions in the root canal. Apex Locator, DPEX III may only be used with stainless steel or nickel titanium endodontic files. The scale indication on the apex locator screen does not represent a distinct length or distance in mm or other linear units. It merely indicates the file progression towards the apex.
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