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510(k) Data Aggregation
K Number
K240950Device Name
Disposable Prophy Angle
Manufacturer
Pacific Care Limited
Date Cleared
2025-05-28
(415 days)
Product Code
EGS
Regulation Number
872.4200Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of DPA is for polishing and cleaning teeth.
Device Description
Plastic one-piece housing (external casing) with 1 internal drive shaft and a spindle installed and aligned at right angle (90 degree) with each other. The tip of spindle is fitted with rubber prophy cup for cleaning and polishing teeth. A small amount of food-grade grease is added between the drive shaft and the spindle as lubrication. The disposable prophylaxis angle is available in a soft cup and firm cup format, which differ in the material used to form the cup. The Medicom and Practicon brands differ in logo and packaging, but utilize the same design.
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K Number
K242514Device Name
Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)
Manufacturer
Shenzhen Rogin Medical Co., Ltd.
Date Cleared
2025-04-24
(244 days)
Product Code
EKX
Regulation Number
872.4200Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Endo Motor with E-LITE MAX, E-LITE PRO and ELITE-INO is 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 position of the file tip inside the canal.
Device Description
### E-LITE MAX & ELITE-INO:
The Endo Motor with E-LITE MAX and ELITE-INO is a low-speed rotating oral equipment mainly used for root canal preparation and root canal measurement. It is designed to enlarge the root canal, facilitate dentin filling, or measuring the root canal length. The product is a portable device consist of a cordless hand-piece and a charge base, it is powered by built-in lithium batteries and charged by the adapter. LCD displays parameters such as speed, torque, file system, Apex etc. Users can also set and modify by keys, and provide design of factory initialization, and calibration of the apex location. It can be used as a low-speed motorized handpiece and device for measuring canal length. The rotary speed and torque range are adjustable.
There are three function features for E-LIT MAX and ELITE-INO:
- Root Canal enlargement: Prepare the root canal with apex locator function.
- Apex Location: Measure the length of the root canal.
- Multi-function: Measuring the length while root canal preparation.
The device can save 9 programs, each program can set different parameters according to the user.
### E-LITE PRO:
The Endo Motor with E-LITE PRO is a low-speed rotating oral equipment mainly used for root canal preparation. It is designed to enlarge the root canal or facilitate dentin filling. The product is a portable device having a cordless hand-piece with a charging adapter, it is powered by built-in lithium batteries and charged by the adapter. LCD displays parameters such as speed, torque, file system, Apex etc. Users can also set and modify by keys, and provide design of factory initialization, and calibration of the apex location. It can be used as a low-speed motorized handpiece and device for measuring canal length. The rotary speed and torque range are adjustable.
There is only one function features for E-LITE PRO:
- Root Canal enlargement: Prepare the root canal, without apex locator function.
The device can save 9 programs, each program can set different parameters according to the user.
The Endo Motor must only be used in hospital environments, clinics or dental offices by qualified dental personnel.
The Endo Motor is intended to be sterilized prior to use.
The compatible device can be used with Endo Motor is rotary instruments such as rotary root canal files, the working part of rotary instruments normally made of Nickel titanium (NiTi). These files are not included in the submission.
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K Number
K242646Device Name
Dental Implant Unit
Manufacturer
Guilin AestheDent Medical Instruments Co., Ltd
Date Cleared
2025-04-11
(220 days)
Product Code
EBW, DAT
Regulation Number
872.4200Why did this record match?
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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 Dental Implant Unit is intended for use in dental surgery, implantology and maxillofacial surgery (CMF) for treatment of dental hard tissue. The device is composed of main unit, motor with tube, handpiece, foot pedal and holder. 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.
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K Number
K241065Device Name
ChecQ (AC100)
Manufacturer
DENTIS Co., Ltd.
Date Cleared
2025-03-21
(337 days)
Product Code
EKX
Regulation Number
872.4200Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ChecQ is indicated for use in measuring the stability of implants in the oral cavity and maxillofacial region.
Device Description
The ChecQ is a dental implant stability analyzer comprising a main unit and a charging cradle that uses Resonance Frequency Analysis (RFA) to measure implant stability non-invasively. It works with the ChecQPEG, which attaches to the dental implant, and measures stability by analyzing resonant frequencies generated by magnetic field stimulation from the probe tip. The stability result is displayed on the main unit's screen as an Implant Stability Quotient (ISQ), ranging from 1 to 99. The RFA method evaluates by applying transverse force to the implant using magnetism, measuring movement, and analyzing the resulting resonance frequency. The resonance frequency depends on the bone-implant gap and is calculated using a formula, with values expressed as ISQ scores (1-99) for clinical interpretation. The ChecQ mechanism converts voltage pulses generated by the DAC of the MCU into magnetic pulses, which induce vibrations in the ChecQPEG magnets. The device captures the free vibrations as magnetic pulses, processes them through an FFT to extract the natural frequency, and calculates the ISQ value based on this frequency.
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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?
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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
K242317Device Name
Integrated Endo System (Meet Endo-II)
Manufacturer
Denjoy Dental Co., Ltd.
Date Cleared
2025-02-13
(192 days)
Product Code
ELC, EKR, EKX
Regulation Number
872.4850Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Integrated Endo System is dental device which combine in a single main control unit an endo motor to clean the root canal, a dental obturator to fill and pressurize, an electronic apex locator to assist the operator to locate the file tip in the root canal and an ultrasonic-handpiece for root-canal cleaning and preparation.
The Integrated Endo System is intended solely for use by trained dental professionals in professional health care facilities on patients that need root-canal-treatment.
Device Description
The Integrated Endo System Meet Endo-II is composed of Main Unit, Adapter, MeetMotor, MeetFill, MeetActivator. It is standalone AC-powered dental control units with a touch display screen to which multiple hand-held dental handpieces for root canal therapy procedure (MeetMotor is for root canal preparation, MeetFill is for root canal backfilling, MeetPex is for working length measurement of root canal, MeetActivator is for root canal irrigation).
These multifunctional devices are intended for use by professionals in the dental clinic use environment. Based on the modular concept of the Integrated Endo System different handpieces can be combined with the control unit. The key hand-held components like handpieces or endodontic tools of the Integrated Endo System are medical devices commercially available by themselves and have separate FDA registration or clearance for marketing in the US.
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K Number
K243911Device Name
HPR Cordless Hygiene Handpiece
Manufacturer
Handpiece Headquarters
Date Cleared
2024-12-20
(1 days)
Product Code
EKX
Regulation Number
872.4200Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HPR Cordless Hygiene Handpiece is a cordless prophylaxis handpiece featuring control buttons and equipped with a battery pack and a wireless foot control. It is designed for use with disposable prophylaxis angles in hygiene operatory to perform cleaning and polishing procedures on teeth surface and fillings.
Device Description
The HPR Cordless Hygiene Handpiece is a cordless prophylaxis handpiece featuring control buttons and equipped with a battery pack and a wireless foot control.
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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?
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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?
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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?
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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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