Who is the manufacturer of Dental Handpiece, Wireless Endodontic Handpiece, endoit?

Micro-Nx Co., Ltd. filed the 510(k) submission for Dental Handpiece, Wireless Endodontic Handpiece, endoit (K232810).

What is the FDA product code for Dental Handpiece, Wireless Endodontic Handpiece, endoit?

EKX. It is classified under 21 CFR 872.4200 as a Class 1 device in the Dental panel.

What is the regulatory pathway for Dental Handpiece, Wireless Endodontic Handpiece, endoit?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Dental Handpiece, Wireless Endodontic Handpiece, endoit?

Dental Handpiece model CA160L (K220577); Endo A Class (K123582).

Who can help prepare an FDA 510(k) submission like Dental Handpiece, Wireless Endodontic Handpiece, endoit?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Dental Handpiece, Wireless Endodontic Handpiece, endoit

K232810 · Micro-Nx Co., Ltd. · EKX · Nov 9, 2023 · Dental

Device Facts

Record ID	K232810
Device Name	Dental Handpiece, Wireless Endodontic Handpiece, endoit
Applicant	Micro-Nx Co., Ltd.
Product Code	EKX · Dental
Decision Date	Nov 9, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.4200
Device Class	Class 1
Attributes	Therapeutic

Intended Use

The Dental Handpiece, Wireless Endodontic Handpiece, endoit, model no. (EH-C500) is intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, and restorations for polishing teeth. The Dental Handpiece is designed for use by a trained professional in the field of general dentistry.

Device Story

Wireless endodontic handpiece (EH-C500) used for general dental procedures; removes carious material, reduces hard tooth structure, prepares cavities/crowns/root canals, removes fillings, and polishes restorations. Device comprises main body with internal battery/micro-motor, connectable contra-angle (EH-A01), charging cradle, and AC/DC adapter. Operator controls rotational speed and torque via buttons on main body; rotational force transmitted to contra-angle head for dental bur operation. Used in dental clinics by trained professionals. Battery-powered operation replaces external motor connection used in predicate devices. Output is mechanical rotational force for dental instruments. Benefits include wireless mobility and rechargeable functionality for endodontic and general dental treatments.

Clinical Evidence

Bench testing only. No clinical data provided. Verification included appearance, operation, rotational speed, noise, and shelf-life tests. Electrical safety and EMC verified per IEC 60601-1 and IEC 60601-1-2. Biocompatibility verified per ISO 10993-1 using data from predicate device.

Technological Characteristics

Wireless, electric, rechargeable handpiece. Components: Main body (PCB, motor, battery), contra-angle (EH-A01), charging cradle, AC/DC adapter. Materials biocompatible per ISO 10993-1. Complies with ISO 14457 (handpieces/motors) and ISO 1797 (shanks). Sterilizable per ISO 17665-1. Push-button chuck design. Motor speed range 120-500 rpm. Gear ratio 1:1.

Indications for Use

Indicated for removal of carious material, reduction of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, and polishing restorations. Designed for use by trained general dentistry professionals.

Regulatory Classification

Identification

A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.

Predicate Devices

Dental Handpiece model CA160L (K220577)
Endo A Class (K123582)

Reference Devices

Dental Handpiece model SG200L (K192809)

Related Devices

K192649 — Endo Motor · Foshan Cicada Dental Instrument Co, Ltd. · Mar 12, 2021
K090931 — CORDLESS ENDO HANDPIECES EB-300, ENTRAN AND EB-300 S, S5 ENDO MOTOR · W&H Dentalwerk Buermoos GmbH · Dec 15, 2009
K092833 — ENDOMAX CORDLESS ENDODONTIC HANDPIECE · Dentamerica · Jan 7, 2010
K123582 — ENDO A CLASS · Saeyang Microtech Co., Ltd. · Aug 16, 2013
K050612 — LIGHTSPEED CORDLESS ENDODONTIC HANDPIECE · Lightspeed Technology, Inc. · May 4, 2005

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below. November 9, 2023 Micro-NX Co., Ltd. % Brandon Green RA Associate K-Bio Solutions 201 South 4th Street, Suite 727 San Jose, California 95112 Re: K232810 Trade/Device Name: Dental Handpiece, Wireless Endodontic Handpiece, endoit Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EKX Dated: September 4, 2023 Received: September 12, 2023 Dear Brandon Green: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). {2}------------------------------------------------ Sincerely, # Michael E. Adjodha -S Michael Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K232810 Device Name Dental Handpiece, Wireless Endodontic Handpiece, endoit, model no.(EH-C500) Indications for Use (Describe) The Dental Handpiece, Wireless Endodontic Handpiece, endoit, model no. (EH-C500) is intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, and restorations for polishing teeth. The Dental Handpiece is designed for use by a trained professional in the field of general dentistry. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------| | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ #### K232810 510(k) SUMMARY Pursuant to Section 510(k) of Chapter V of the Federal Food, Drug, and Cosmetic Act and in accordance with subpart E of Part 807, Title 21 of the Code of Federal Regulations, MICRO-NX Co., Ltd. submits the following information as premarket notification for the proposed device, Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) #### I. SUBMITTER 510(k) Correspondent: Brandon Green RA Associate, K-Bio Solutions (brandon.green@kbiotechsolutions.com) Tel: 82-2-597-2700 Sponsor: MICRO-NX Co., Ltd. 22, Maeyeo-ro 1 gil, Dong-gu, Daegu Postal code: 41059, Republic of Korea Tel: 82-053-650-1000 Fax: 82-053-650-1005 Manufacturer Contact: Haim Yoon (haimyoon1@micronx.co.kr) Date Prepared: September 4th, 2023 #### II. SUBMISSION DEVICE - Trade Name(s) of Device: Dental Handpiece, Wireless Endodontic Handpiece, ● endoit (model number: EH-C500) - Regulation Number: 21 CFR 872.4200 ● - Regulation Name: Dental handpiece and accessories ● - Product Code: EKX (Handpiece, Direct Drive, Ac-Powered) ● - Review Panel: Dental - Regulatory Class: Class I ● - Traditional 510(k) Registration . Prior formal correspondence with the FDA resulted in the 510(k) clearance of the Micro-NX Dental Handpiece (K220577) Model CA160, CA160L, and CA500L #### III. PREDICATE DEVICES - Dental Handpiece model CA160L (K220577), Manufacturer: Micro-NX Co., Ltd. ● - Endo A Class (K123582), Manufacturer: Saeyang Microtech Co., Ltd. ● {5}------------------------------------------------ #### IV. DEVICE DESCRIPTION The intended use of the proposed Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) is the same as the intended use of the predicate (K220577) Dental Handpiece model CA160L and similar to the predicate (K123582) Endo A Class. - Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) . is intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, restorations, and for polishing teeth. The Dental Handpiece is designed for use by a trained professional in the field of general dentistry. - Predicate Dental Handpiece (K220577) model CA160L is intended for the removal of . carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, restorations, and for polishing teeth. The Dental Handpiece is designed for use by a trained professional in the field of general dentistry. - . Predicate Endo A Class (K123582) has the following intended use: This application area extends to endodontic procedures using a root canal instrument which is intended by the manufacturer for use in the mechanical and rotary preparation of root canals. Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) consists of a Main Body, connectable Contra Angle, Charging Cradle, and AC/DC Adapter. The Main Body of the handpiece is used for transmitting rotational force required in general dental treatment. The torque transmitted from a wireless electric micro-motor gets further transmitted to the joint part of the device. The rotational force is then decelerated according to the speed reducer of the gear which is transmitted to the head of the dental handpiece. The rotational force is transmitted under the permitted rotation mechanism. Compared to the predicate device Dental Handpiece model CA160L (K220577), the Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) contains additional components of a Charging Cradle and AC/DC Adapter. Therefore, the primary distinction between the predicate device (K220577) and the EH-C500 is their power/charging method. The EH-C500 relies on the AC/DC Adapter and Charging Cradle to recharge its Main Body, whereas the predicate (K220577) receives electrical input from an external electric motor that is typically attached to the distal end of the dental handpiece's Main Body. Thus, the main technological characteristics in terms of achieving the intended use for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, and for polishing teeth are identical between the predicate (K220577) and Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) Compared to the predicate device Endo A Class (K123582), the Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) has the same components and similar {6}------------------------------------------------ technological characteristics including a connectable Contra Angle, charging method, and wireless functionality. The identified difference between the Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) and predicate Dental Handpiece model CA160L (K220577) lies primarily within their power/charging methods. However, this difference has been assessed and it has been determined not to raise different questions regarding the safety or effectiveness of either the predicate devices CA160L and Endo A Class or the proposed device EH-C500, which have been tested according to the FDA's recognized IEC standards listed below: - . IEC 60601-1 (2005) "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance" - IEC60601-1-2 (2014) "Edition 4.0 2014-02 Medical electrical equipment Part 1-2: . General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests" The aforementioned IEC testing of the Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) is provided as eCopy 007 and eCopy 008. Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) is provided with a connectable Contra Angle component, that is connected to the Main Body, The Contra Angle and Main Body of the Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) together make up the main body system of the device. Essentially, the Contra Angle and Main Body of the Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) together serve the similar technological characteristics as the main body system of the predicate (K220577) Dental Handpiece model CA160L. Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) is a wireless, electric, and chargeable device utilized in root canal treatment. The battery inside the Main Body of the proposed Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) generates power to transmit rotational force for the general dental treatments. The speed of the rotation and torque value can be controlled using the buttons on the main body of the device. The rotational force is transmitted under the permitted rotation mechanism. Components associated with the Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) are the Main Body, Contra Angle (EH-A01), Charging Cradle, and AC/DC Adapter. The Charging Cradle and AC/DC Adapter are accessory components of the device. Components associated with the predicate Dental Handpiece model CA160L are the Main Body handle which includes Contra Angle. The accessory component associated with the CA160L model is the Spray Adapter. Components associated with the predicate Endo A Class are the Main Body, Contra Angle, Charging Cradle, and AC/DC Adapter. The Charging Cradle and AC/DC Adapter are accessory components of the device. {7}------------------------------------------------ The components of the proposed Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) in comparison of those of the predicate devices Dental Handpiece model CA160L and Endo A Class are provided in Table IV-1 below. | Model | Proposed Device: EH-C500 | Predicate Device: CA160L | Predicate Device: Endo A Class | |--------------------------------|-----------------------------|-----------------------------|-----------------------------------| | Main Body | X | X | X | | Contra Angle | X | X | X | | Charging Cradle (accessory) | X | X | X | | AC/DC Adapter (accessory) | X | X | X | | Spray Adapter (accessory) | X | X | X | Table IV-1 Proposed Device Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) Component Specification The component names and function of the proposed Dental Handpiece. Wireless Endodontic Handpiece, endoit (model number: EH-C500) and predicate Dental Handpiece model CA160L are provided in Table IV-2 and Table IV-3 below. Table IV-2 Component Names and Functional Descriptions for Critical Components of Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) | No. | Component Name | Function | |-------------------------------------------------------------------------------------------------------------------|--------------------------|----------------------------------------------------------------------------------------------------------------------------| | A. Components of Main Body of the Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) | | | | A1 | Handpiece Top Case | Top part of the Handpiece case | | A2 | Handpiece Bottom Case | Bottom part of the Handpiece case | | A3 | Name plate | Sticker for button identification and exterior design | | A4 | Button | Button to activate functions of the Dental Handpiece | | A5 | LCD Plate | Protects LCD | | A6 | PCB Assembly | Internal PCB | | A7 | Handle Cap | For connecting internal parts | | A8 | Index Ring | For connecting internal parts | | A9 | Motor Assembly | Motor that transmits rotational power | | A10 | Battery | Power the motor | | B. Contra Angle (EH-A01) | | | | B1 | Head Assembly | Transmits rotational power from the handpiece to the bur | | B2 | Shank Assembly | Connects Handpiece and the Head part | | No. | Component Name | Function | | A. Components of Main Body of the Dental Handpiece Model CA160L | | | | A1 | Spindle Assembly | Receives torque from Middle Gear Assembly and transmits torque to final dental bur | | A2 | Middle Gear Assembly | Transmitting the rotational force from the Inner Handle Assembly and delivers the rotational force to the Spindle Assembly | | A3 | Button Assembly | Button for removal and attachment of the hand piece head | | A4 | Head Cap | Case that wraps the Spindle Assembly. Head Cap is assembled with Button Assembly and Middle Gear Assembly | | A5 | Head Assembly | The component that is assembled Spindle Assembly, Middle Gear Assembly, Button Assembly, Head Assembly | | A6 | Gear Box Assembly | It consists of several gears and decelerates. | | A7 | Joint Gear Assembly | Transmits the torque received from the motor to the Head Assembly | | A8 | Inner Handle | Case to fix Joint Assembly | | A9 | Locking Handle | Head assembly's attachment and detachment. | | A10 | Angle Handle Assembly | The case of Joint Gear Assembly, Optic, Head | | B. Components only available for CA160L | | | | B1 | Optic | Optical fiber that allows light to pass from the motor's LED light source to the handpiece head | | B2 | Angle Body | The case is installed in Handle Assembly and protect the optics. | {8}------------------------------------------------ Table IV-3 Component Names and Functional Descriptions for Critical Components of Dental Handpiece model CA160L ### V. INDICATIONS FOR USE/INTENDED USE Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) is intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth {9}------------------------------------------------ preparations, and restorations for polishing teeth. The Dental Handpiece is designed for use by a trained professional in the field of general dentistry. # VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE Fundamental technological characteristics of Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) are substantially equivalent to the predicate devices, MICRO-NX Dental Handpiece model CA160L (K220577) and Saeyang Microtech Co., Ltd. Endo A Class (K123582) as demonstrated in Table VI-1 below. | | Proposed Device: Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) | Predicate Device: Dental Handpiece model CA160L (MICRO-NX, K220577) | Predicate Device: Endo A Class (Saeyang Microtech Co., Ltd., K123582) | Substantial Equivalence Assessments | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use / Indications for Use | Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) is intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, and restorations for polishing teeth. Dental Handpiece is designed for use by a trained professional in the field of general dentistry. | Dental Handpiece model CA160L is intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, and restorations for polishing teeth. Dental Handpiece is designed for use by a trained professional in the field of general dentistry. | This application area extends to endodontic procedures using a root canal instrument which is intended by the manufacturer for use in the mechanical and rotary preparation of root canals. | Intended use and indications for use are the same between Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) and the predicate device Dental Handpiece model CA160L for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, and restorations for polishing teeth. Dental Handpiece is designed for use by a trained | | | | | | field of general dentistry. | | Functional Principle | Compared to the predicate (K220577) Dental Handpiece model CA160L that is coupled to handpiece connectors to receive energy, the proposed Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) has a built-in battery in the main body that generates torque force to transmit rotational force to the contra angle for the general dental treatments. | Through the micro motor connected to the dental treatment unit, the Dental Handpiece model CA160L contra angle handpiece is equipped with a handpiece connection that receives the energy, the cooling water and air for treatment and the light for illumination the operating area. | The motor turned by the power converted into DC2.4V by controller delivers its turning power to the file through spin to perform punching, cutting and removing functions. The hand-piece can be operated, stopped and set/adjusted on/in its speed, torque and turning direction by handling of the controller. | Similar Functional Principle In order to address the wireless function of the proposed device, an additional predicate device, Endo A Class, is being submitted. The wireless function does not raise questions about the safety or effectiveness of the proposed device compared to the predicate device. | | Dimensions | Main Body Width: 23mm Length: 27mm Height: 155mm Contra Angle (EH-A01) Diameter: 17mm Length: 71mm Height: 30mm Head Length: 8.1mm | Connection Diameter: 20mm Length: 95mm Head Length: 14mm Head Diameter: 9mm | Main Body Width: 27mm Length: 28mm Height: 192mm | The head size, height, and diameter of Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) are broadly in alignment with the dimensions of the predicate | | | Head Diameter: 10.7mm | | | (K220577) Dental Handpiece model CA160L. The minor differences in the identified dimensions do not raise different questions in terms of the safety or effectiveness of the proposed Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500). | | Direct patient- contacting portions of the device | All materials for the Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) are listed in the raw material table including chemical composition of the waterlines and the patient-contacting portions of the device. Biocompatible according to ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system - ISO 10993-1:2009) | All materials for Dental Handpiece models are listed in the raw material table including chemical composition of the waterlines and the patient-contacting portions of the device. Biocompatible according to ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system - ISO 10993-1:2009) | Biocompatible according to ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system - ISO 10993-1:2009) | The proposed Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) is an additional model to the predicate (K220577) Dental Handpiece model CA160L and has identical in-direct patient contacting materials. Therefore, the predicate device biocompatibility test results per the standard of ISO 10993-1 are applicable to the proposed Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500). | | Indirect patient- contacting portions of the device | All materials for the Dental Handpiece, Wireless Endodontic | All materials for Dental Handpiece model CA160L are listed in the tables above including | Biocompatible according to ISO 10993-1 (Biological evaluation of | The proposed Dental Handpiece, Wireless Endodontic Handpiece, endoit | | (water / air lines) | | | | | | Handpiece, endoit (model number: EH-C500) are listed including chemical composition of the waterlines and the patient-contacting portions of the device. Biocompatible according to ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system - ISO 10993-1:2009) | chemical composition of the waterlines and the patient-contacting portions of the device. Biocompatible according to ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system - ISO 10993-1:2009) | medical devices - Part 1: Evaluation and testing within a risk management system - ISO 10993-1:2009) | (model number: EH-C500) is an additional model to the predicate (K220577) Dental Handpiece model CA160L and has identical in-direct patient contacting materials. Therefore, the predicate device biocompatibility test results per the standard of ISO 10993-1 are applicable to the proposed Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500). | | | Charging Method | Charging Cradle | External electric motor | Charging Cradle The charging method of the proposed Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) is a charging cradle, identical to the predicate device (K123582). | | | Chuck Design | Push Button Chuck | Push Button Chuck | Push Button Chuck The chuck design of the proposed Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) is push button chuck, identical to the predicate device | | | Motor Speed Range (RPM's) | 120 ~ 500 rpm | Up to 20,000 rpm | 140-500rpm | The motor speed range of the proposed Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) is within a lower range compared to the predicate (K220577) CA160L Dental Handpiece model. Since the maximum speed range of the predicate device encompasses the speed range of the proposed model, it does not have any significant impact on establishing substantial equivalence. | | Conformance Standards (Handpieces and Motors) | ISO 14457 (Dentistry - Handpieces and motors - ISO 14457:2012) | ISO 14457 (Dentistry - Handpieces and motors - ISO 14457:2012) | ISO 14457 (Dentistry - Handpieces and motors - ISO 14457:2012) | Compliant with the same standards for dentistry handpiece and motors. | | Conformance Standards (Shanks) | ISO 1797 (2017) "Dentistry - Shanks for rotary and oscillating instruments" | ISO 1797 (2017) "Dentistry - Shanks for rotary and oscillating instruments" | ISO 1797 (2017) "Dentistry - Shanks for rotary and oscillating instruments" | Compliant with the same standards of dentistry shanks. | | Sterilization | Sterilizable according to ISO 17665-1 (Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices on the final | Sterilizable according to ISO 17665-1 (Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices on the final | Sterilizable according to ISO 17665-1 (Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices on the final | Conform to the same standards for user sterilization. | | finished device - ISO 176651:2006) | finished device - ISO 176651:2006) | finished device - ISO 176651:2006) | | | | Gear Ratio | 1:1 | 16:1 | 4:1, 10:1, 16:1, 20:1 | Compared to the predicate (K220577) of Dental Handpiece model CA160L gear ratio of 16:1, the proposed Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) lower gear ratio of 1:1 does not raise different questions in terms of the safety or effectiveness of the proposed Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH C500) | #### Table VI-1. Substantial Equivalence Assessment between Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) and Predicate Devices (K220577) and K(123582) {10}------------------------------------------------ {11}------------------------------------------------ {12}------------------------------------------------ {13}------------------------------------------------ {14}------------------------------------------------ Overall, design verification testing were performed to assess the following critical elements of medical devices used in dentistry applications. The favorable test results of the proposed device which confirmed to meet the FDA recognized standards as well as ISO standard demonstrate that the proposed Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) retains the substantially equivalent profile in safety and essential performance of medical electrical equipment as the predicate (K220577) Dental Handpiece model CA160L and predicated (K123582) Endo A Class. - ISO 14457 (2017) "Dentistry Handpieces and motors" (Recognition List Number: 031 . Effective Date: 09/15/2012) - ISO 1797 (2017) "Dentistry - Shanks for rotary and oscillating instrument The following IEC standard tests have been completed to evaluate electrical safety and performance of the Dental Handpiece. Wireless Endodontic Handpiece, endoit (model number: EH-C500): - IEC 60601-1 (2005) "Medical electrical equipment Part 1: General requirements for basic ● safety and essential performance" {15}------------------------------------------------ - IEC60601-1-2 (2014) "Edition 4.0 2014-02 Medical electrical equipment Part 1-2: ● General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests" # VII. DESIGN VERIFICATION & PERFORMANCE DATA The following design verification and performance data are provided in support of the conclusive determination that the proposed dental handpiece is substantially equivalent to the predicate device Dental Handpiece model CA160L (MICRO-NX, K220577). #### Biocompatibility Testing The biocompatibility testing conducted for the predicate device Dental Handpiece model CA 160L(MICRO-NX, K220577) is applicable to the proposed Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500). The proposed Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) is an additional model to the predicate device Dental Handpiece model CA160L (MICRO-NX, K220577). All of the patientcontacting raw materials of the proposed Dental Handpiece. Wireless Endodontic Handpiece, endoit (model number: EH-C500) are the same as the predicate device Dental Handpiece (MICRO-NX, K220577) with no new introduction of patient contacting raw materials for the proposed Dental Handpiece model. In accordance with ISO 10993-1: 2009. Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process, the Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) is categorized under "Externally Communicating Device-Tissue/bone/dentin (Limited contact duration). This is the same category of the biocompatibility evaluation as the predicate (K220577) Dental Handpiece model CA160L. The biocompatibility testing has been conducted with the FDA-approved Dental Handpiece model SG200L (K192809) in 2019 in order to ensure FDA's latest consensus standards with respect to biological safety evaluations are met for the proposed device. The predicate (K220577) Dental Handpiece model CA160L was approved by the FDA on July 29th, 2022 and in this submission the Dental Handpiece including model SG200L was used as the predicate device (K192809) for substantial equivalence. The Dental Handpiece model CA160L (K220577) and Dental Handpiece including model SG200L (K192809) were assessed as substantially equivalent and the biocompatibility test results of the Dental Handpiece model SG200L was used as evidence for the Dental Handpiece CA160L (K220577). - ISO MEM Elution Using L-929 Mouse Fibroblast Cells (GLP) - ISO Guinea Pig Maximization Sensitization Test (GLP 2 Extracts) ● - ISO Intracutaneous Irritation Test (GLP 2 Extracts) ● - ISO Materials Mediated Rabbit Pyrogen (GLP) ● - . ISO Acute Systemic Injection Test (GLP - 2 Extracts) {16}------------------------------------------------ #### Design Verification and Validation Testing The proposed, Micro-NX Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) has been evaluated and risk management practices have been implemented in accordance with ISO 14971:2019/A1:2021 Medical devices - applications of risk management to medical devices. - Appearance Test ● - Operation Test - Rotational Speed Test ● - . Noise Test - Serviceable Year/ Shelf-Life Test ● - IEC 60601-1 - IEC 60601-1-2 ● The favorable results of the design verification testing demonstrate the design output of Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) conforms to the applicable, pre-determined design requirements of the Dental Handpiece. The testing results also further demonstrate the proposed Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) is substantially equivalent to the predicate (K220577) Dental Handpiece model CA160L, as the proposed and predicate device are subject to the same applicable test standards of design requirements for dental handpieces. Therefore, the identified differences in terms of the dimensions and outer appearance between the proposed Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) and the predicate (K220577) Dental Handpiece model CA160L do not raise different questions regarding the safety or effectiveness of the proposed device. ### VIII. CONCLUSIONS Overall, the proposed device is assessed substantially equivalent to the predicate devices given the fact that its indications for use are the same, and fundamental technological characteristics are equivalent to those of the predicate device Dental Handpiece (MICRO-NX, K220577). The positive outcomes from the design verification and performance testing mentioned above confirm alignment with the relevant standards related to dental handpieces. Furthermore, they highlight that there are no additional concerns regarding safety and effectiveness assessment when compared to the predicate devices of Dental Handpiece model CA160L (MICRO-NX, K220577) or the Endo A Class (K123582).