Who is the manufacturer of Dental Handpiece?

Micro-Nx Co., Ltd. filed the 510(k) submission for Dental Handpiece (K192809).

What is the FDA product code for Dental Handpiece?

EFA. 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?

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

Who can help prepare an FDA 510(k) submission like Dental Handpiece?

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

Q: What are the predicate devices for Dental Handpiece?

SMARTmatic (K163239); Anthogyr Contra Angles and Handpieces (K093894).

K192809 · Micro-Nx Co., Ltd. · EFA · Aug 25, 2020 · Dental

Device Facts

Record ID	K192809
Device Name	Dental Handpiece
Applicant	Micro-Nx Co., Ltd.
Product Code	EFA · Dental
Decision Date	Aug 25, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.4200
Device Class	Class 1
Attributes	Therapeutic

Intended Use

Dental Handpiece with models of SG200, SG200L, SA100L, and CA100L, and CA100R are 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 for polishing teeth. In addition, Dental Handpiece with models of SG200, SG200L are also intended for implant surgery such as perforating the bone, tapping and threading procedures. Dental Handpiece is designed for use by a trained professional in the field of general dentistry.

Device Story

Dental handpiece (models SG200, SG200L, SA100L, SA100R, CA100L, CA100R) transmits rotational force from an electric micro-motor to a dental bur for general dental procedures and implant surgery. Device connects to dental units via ISO 3964 coupling; receives energy, cooling water, and air. Rotational force is decelerated via internal gear speed reducers. Features include push-button or latch-type chucks for bur attachment. Used by trained dental professionals in clinical settings. Sterilizable via steam autoclave. Provides mechanical cutting/drilling capability; aids in restorative and surgical procedures.

Clinical Evidence

Bench testing only. No clinical data provided. Verification included rotational speed, noise, water supply, light, operation, and appearance testing. Biocompatibility testing included MEM elution, sensitization, intracutaneous irritation, pyrogenicity, and acute systemic injection tests.

Technological Characteristics

Reusable, electrically-powered dental handpiece. Materials biocompatible per ISO 10993-1. Complies with ISO 14457 (handpieces/motors), ISO 3964 (coupling), and ISO 1797 (shanks). Features internal/external spray, gear ratios 20:1/1:1, and optical fiber for illumination (select models). Sterilization: steam autoclave per ISO 17665-1.

Indications for Use

Indicated for trained dental professionals to perform removal of carious material, tooth structure reduction, cavity/crown/root canal preparations, filling removal, and finishing/polishing. Models SG200 and SG200L are additionally indicated for implant surgery (bone perforation, tapping, threading).

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

SMARTmatic (K163239)
Anthogyr Contra Angles and Handpieces (K093894)

Related Devices

K040674 — IMPLANTOLOGY CONTRA ANGLES, ENDODONTIC CONTRA ANGLES, GENERAL DENTISTRY CONTRA ANGLES · Anthogyr · Jun 30, 2004
K020137 — AHP-66 4:1 REDUCTION CONTRANGLE: AHP-88 8:1 REDUCTION CONTRANGLE: AHP-88MP 8:1 REDUCTION CONTRANGLE - PUSH BUTTON · Aseptico, Inc. · Mar 4, 2002
K220577 — Dental Handpiece, Model CA160, CA160L, and CA500L · Micro-Nx Co., Ltd. · Jul 29, 2022
K171436 — STRONG Dental Handpieces · Saeshin Precision Co., Ltd. · Jan 5, 2018
K182999 — General Cutting Contra Handpiece · Nakanishi, Inc. · Apr 16, 2019

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. August 25, 2020 Micro-NX Co., Ltd. % Kyungyoon Kang CEO K-Bio Solutions 589 Oakwood Drive Santa Clara, California 95054 Re: K192809 Trade/Device Name: Dental Handpiece Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I Product Code: EFA Dated: May 20, 2020 Received: May 27, 2020 Dear Kyungyoon Kang: 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 (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 located 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}------------------------------------------------ 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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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). Sincerely. For Srinivas "Nandu" Nandkumar, Ph. D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic. Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K192809 Device Name Dental Handpiece Indications for Use (Describe) Dental Handpiece with models of SG200, SG200L, SA100L, and CA100L, and CA100R are 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 for polishing teeth. In addition, Dental Handpiece with models of SG200, SG200L are also intended for implant surgery such as perforating the bone, tapping and threading procedures. 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) | |-------------------------------------------------| |-------------------------------------------------| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) #### 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." {3}------------------------------------------------ # K192809 ### 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. ### I . SUBMITTER 510(k) Correspondent: Kyungyoon Kang CEO, K-Bio Solutions (Kyungyoon.kang@kbiotechsolutions.com) Tel: 82-2-597-2700 (US: 812-345-7485) 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 510(k) Number: K192809 Manufacturer Contact: Sojeong Park (sojeong@micronx.co.kr) Date Prepared: August 25th, 2020 ### II . SUBMISSION DEVICE - Trade Name: Dental Handpiece ● - Common Name: Handpiece, dental - Classification Name: Dental handpiece and accessories ● - Regulation Number: 21 CFR 872.4200 ● - Regulation Name: Dental handpiece and accessories - Product Code: EFA (handpiece, belt and/or gear driven, dental) ● - Review Panel: Dental ● - . Regulatory Class: Class I Traditional 510(k) Registration (There were no prior submissions for the proposed, Micro-NX Dental Handpiece, which is labeled for 5 year shelf life) ### II. PREDICATE DEVICES - SMARTmatic (K163239), Manufacturer: Kaltenbach & Voigt GmbH ● - Anthogyr Contra Angles and Handpieces (K093894). Manufacturer: Anthogyr ● These predicate devices have not been subject to a design-related recall. {4}------------------------------------------------ ## IV. DEVICE DESCRIPTION Dental Handpiece with models of SG200, SG200L, SA100L, SA100R, CA100L, and CA100R are 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. In addition, Dental Handpiece with models of SG200, SG200L are also intended for implant surgery such as perforating the bone, tapping and threading procedures. Dental Handpiece is designed for use by a trained professional in the field of general dentistry. The proposed dental handpiece consists of the main body of a handpiece, which is used for transmitting a rotational force for the general dental treatments as well as accessory components. which are used for channeling water and air for further applications to the dental treatments. The torque transmitted from an electric micro-motor gets further transmitted to the joint part of Dental Handpiece. The rotational force is then decelerated according to the speed reducer of the gear to be transmitted to the head of the dental handpiece. The rotational force is transmitted under the permitted rotation mechanism. The product is offered as an electrical-powered Dental Handpiece that is reusable and ergonomically shaped. The dental handpiece can be sterilized by the steam autoclave method. Through the tube and the electrical motor connected to a dental unit, the Dental Handpiece equipped with a handpiece connection according to ISO 3964 (Dentistry - Coupling dimensions for handpiece connectors - ISO 3964:1982) receive the energy for the gear, the cooling water and air for cutting treatment. Dental burs and other attachments will be used with the proposed Dental Handpiece per ISO 1797:2017 (Dentistry - Shanks for rotary and oscillating instruments). Dental Handpiece has been developed with a full range of surgical contra angle intended to be used in implantology. The contra angle-design, size and performance of the proposed Dental Handpiece conform to ISO 14457 (2017) "Dentistry -Handpieces and motors" The six (6) product codes and models of Dental Handpiece are SG200L, SG200, CA100L, CA100R. SA100L. SA100R.The component names and functional descriptions for critical components of Dental Handpiece are provided in the table below. | Table IV-1. Component Names and Functional Descriptions for Critical Components of | | |---------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Dental Handpiece: SG200L, SG200, CA100L, CA100R | | | Component Name | Function | | Components which are commonly included in the models of SG200L, SG200, CA100L, CA100R | | | Spindle Assembly | Receives torque from Middle Gear Assembly and transmits torque to final dental bur | | Middle Gear Assembly | Transmitting the rotational force from being Housing Assembly also delivering the rotational force to the Spindle Assembly | | Button Assembly | Button for removal and attachment of the hand piece head | | Head Cap | Case that wraps the Middle Gear Assembly and Housing Assembly, and the Button Assembly is assembled | | Head Assembly | The component that is assembled Spindle Assembly, Middle Gear Assembly, Button Assembly, Head Assembly | | Housing Assembly | Transmits the torque received from Joint Assembly to Middle Gear Assembly | | Joint Assembly | Transmits the torque received from the motor to the Housing Assembly | | Inner Handle | Case to fix Joint Assembly | | Planetary Gear Assembly | The component that is assembled Housing Assembly, Joint Assembly, Inner Handle | | Spray Adapter | Adapter to help oil fill the handpiece | | Components only available for SG200L | | | Optic | Optical fiber that allows light to pass from the motor's LED light source to the handpiece head | | Angle Handle | The case of Planetary Gear Assembly, Optic, Head Assembly | | Angle Body Assembly | The case is installed in Handle Assembly and has two parts where the light passing through the optical fiber comes out and the part where the Pipe Clip can be fixed | | Handle Assembly | The component that is assembled Optic, Angle Handle | | Pipe Clip | Clip to fix Outside Pipe mounted on specific groove of Angle Body Assembly | | Y-coupling | Supply water from the external water supply line to the spray nozzle and outside pipe | | Tube Clip | Fix the external water line to the handpiece | | Inside Pipe | Pipes attached to the handpiece head to supply water | | Outside Pipe | Pipes fixed to Pipe Clip pipe to supply water | | Components only available for SG200 | | | Angle Handle | The case of Planetary Gear Assembly, Optic, Head Assembly | | Angle Body Assembly | The case is installed in Handle Assembly and has two parts where the light passing through the optical fiber comes out and the part where the pipe clip can be fixed | | Spray Nozzle | Pipe for water supply mounted on the handpiece head | | Pipe Clip | Clip to fix Outside Pipe mounted on specific groove of Angle Body Assembly | | Y-coupling | Supply water from the external water supply line to the spray nozzle and outside pipe | | Tube Clip | Fix the external water line to the handpiece | | Outside Pipe | Pipes fixed to Pipe Clip pipe to supply water | | Components only available for CA100L | | | Handle Assembly | The component that is assembled Optic, Angle Handle | | Angle Body Assembly | The case is installed in Handle Assembly and has two parts where the light passing through the optical fiber comes out and the part where the pipe clip can be fixed | | Angle Handle | The case of Planetary Gear Assembly, Optic, Head Assembly | | Optic | Optical fiber that allows light to pass from the motor's LED light source to the handpiece head | | Irrigation Pipe Assembly | Pipes for water supply | | Components only available for CA100R | | | Handle Assembly | The component that is assembled Optic, Angle Handle | | Angle Body Assembly | The case is installed in Handle Assembly and has two parts where the light passing through the optical fiber comes out and the part where the pipe clip can be fixed | | Angle Handle | The case of Planetary Gear Assembly, Optic, Head Assembly | | Irrigation Pipe Assembly | Pipes for water supply | {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ ### Table IV-2. Component Names and Functional Descriptions for Critical Components of Dental Handpiece: SA100L, SA100R | Components which are commonly included in the models of SA100L, SA100R | | |------------------------------------------------------------------------|---------------------------------------------------------------------| | Spindle Assembly | Receives torque from motor and transmits torque to final dental bur | | Cam | A Component to fix the bottom of Spindle Assembly | | Inner Handle | A component that is assembled Spindle Assembly | | Nose Cap | An outer case assembled the front part of Cam Handle Assembly | | Cam Handle Assembly | An outer case that is assembled Nose Cap, Angle Handle. | | Angle Handle | An outer case assembled the back part of Cam Handle Assembly | | Irrigation Pipe Assembly | Pipes for water supply | | Handle Fixing Bolt | Assembled and fastened at the bottom of the handpiece | | Spray Adapter | Adapter to help oil fill the handpiece | | Components only available for SA100L | | {8}------------------------------------------------ | Optic | Optical fiber that allows light to pass from the motor's LED light source to the handpiece head | |-------|----------------------------------------------------------------------------------------------------| |-------|----------------------------------------------------------------------------------------------------| ### V. INDICATIONS FOR USE/INTENDED USE Dental Handpiece with models of SG200, SG200L, SA100L, SA100R, CA100L, and CA100R are 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. In addition, Dental Handpiece with models of SG200, SG200L are also intended for implant surgery such as perforating the bone, tapping and threading procedures. 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 MICRO-NX dental handpiece are substantially equivalent to the predicate devices, SMARTmatic and ANTHOGYR Contra angles and Handpieces as demonstrated in Table VI-1 below. | Comparison Category | Proposed Device: Dental Handpiece | Predicate Device: SMARTmatic (K163239) | Predicate Device: ANTHOGYR Contra angles and Handpieces (K093894) | Substantial Equivalence Assessments | |-------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use /Indications for Use | Dental Handpiece with models of SG200, SG200L, SA100L, SA100R, CA100L, and CA100R are 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 | The SMARTmatic handpieces are 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 | ANTH-OGYR'S fully autoclavable contra-angles Implantology Impulsion are devices intended for a wide range of dental procedures including: Implant surgery such as perforating the bone, tapping and threading procedures | Intended use and indications for use are the same between Dental Handpiece and the predicate device of SMARTmatic handpieces, for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of | | | restorations for polishing teeth. In addition, Dental Handpiece with models of SG200, SG200L are also intended for implant surgery such as perforating the bone, tapping and threading procedures. Dental Handpiece is designed for use by a trained professional in the field of general dentistry. | They are designed for use by a trained professional in the field of general dentistry. | fillings, processing and finishing tooth preparations, and restorations for polishing teeth. The intended use of the predicate, ANTHOGYR for implant surgery such as perforating the bone, tapping and threading procedures is the same as the intended use of Micro-NX dental handpiece for models of SG200, SG200L. | | | Functional Principle | Through the micro motor connected to the dental treatment unit, the straight and contra-angle handpieces equipped with a handpiece connection according to ISO 3964 (Dentistry - Coupling dimensions for handpiece connectors - ISO 3964:1982) receive the energy, the cooling water and air for treatment and the light for illumination the operating area. | Through the micro motor connected to the dental treatment unit, the straight and contra-angle handpieces equipped with a handpiece connection according to ISO 3964 (Dentistry - Coupling dimensions for handpiece connectors - ISO 3964:1982) receive the energy, the cooling water and air for treatment and the light for illumination the operating area. | Through the micro motor connected to the dental treatment unit, the straight and contra-angle handpieces equipped with a handpiece connection according to ISO 3964 (Dentistry - Coupling dimensions for handpiece connectors - ISO 3964:1982) receive the energy, the cooling water and air for treatment and the light for illumination the operating area. | Same Functional Principle | | Dimensions | Head size- Height: Up to 14mm Head size-Diameter: Up to 9mm Length: Up to 95.80mm | Head size-Height: Up to 13.6 mm Head size- Diameter: Up to 9.8 mm Length: Up to 93.4 mm | Head size-Height: Up to 13.02mm Head size- Diameter: Up to 10.07 mm Length: Up to 104.84mm | The head size, height, and diameter of MICRO-NX Dental Handpiece are broadly in alignment with the | | | | | | dimensions of the | | | | | | predicate, | | | | | | SMARTmatic | | | | | | handpiece. The | | | | | | minute differences | | | | | | in the identified | | | | | | dimensions do not | | | | | | raise different | | | | | | questions of safety | | | | | | and effectiveness. | | Direct patient- contacting portions of the device | All materials for MICRO-NX Dental Handpiece models are listed in the raw material table below 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 the SMARTmatic models are listed in the tables below 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) | All patient contacting materials of MICRO-NX Handpiece have been tested per the same standards of ISO 10993-1. Given the favorable biocompatibility test results, the differences in patient contacting materials do not raise different questions in terms of safety and effectiveness. | | Indirect patient- contacting portions of the device (water / air lines) | All materials for MICRO-NX Dental Handpiece models are listed in the tables below 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 the SMARTmatic models are listed in the tables below 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) | All in-direct patient contacting materials of MICRO-NX Handpiece have been tested per the same standards of ISO 10993-1. Given the favorable biocompatibility test results, the differences in patient contacting materials do not raise different questions of safety and effectiveness. | | | | system - ISO 10993-1:2009) | | | | Chuck Design | Push Button, Latch Type | Push Button, Twist-tension Chuck, Snap-on & Screw-in | Push Button, Latch Type | The chuck design of MICRO-NX Dental Handpiece is the same as the predicate, ANTHOGYR (K093894). | | Speed Range (RPM's) | Up to 40,000 rpm | Up to 40,000 rpm | Up to 40,000 rpm | Same Speed Range | | 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 1797-1 (2011) "Dentistry - Shanks for rotary instruments - Part 1: Shanks made of metals" | ISO1797-1(1995) "Dental rotatory instruments - Shanks - Par 1: Shanks made of metal" | Compliant with the same standards of dentistry shanks. | | Conformance Standards (Coupling Dimensions) | ISO 3964 (Dentistry - Coupling dimensions for handpiece connectors - ISO 3964:1982) | ISO 3964 (Dentistry - Coupling dimensions for handpiece connectors - ISO 3964:1982) | ISO 3964 (Dentistry - Coupling dimensions for handpiece connectors - ISO 3964:1982) | Compliant with the same standards of dentistry coupling dimensions. | | Sterilization | Sterilisable 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 | Sterilisable according to ISO 17665-1 (Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a | Sterilisable according to ISO 17665-1 (Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a | Conform to the same standards for user sterilization. | | | on the final, finished device - ISO 176651:2006) | sterilization process for medical devices on the final, finished device - ISO 176651:2006) | sterilization process for medical devices on the final, finished device - ISO 176651:2006) | | | Air / water ports | Internal/ External Spray | No Spray / External Spray | External Spray | Internal spray function added to provide an additional option to the users. Given the favorable test results of the internal spray components, the addition does not raise different questions of safety and effectiveness. | | Gear Ratio | 20:1/ 1:1 | 8:1/32:1/1:1 | 20:1 | Compared to the predicate device of SMARTmatic device, the addition of a gear ratio of 20:1 does not raise different questions of safety and effectiveness given the favorable test results of performance testing of MICRO-NX Dental Handpiece. | Table VI-1. Substantial Equivalence Assessment between MICRO-NX Dental Handpiece and Predicate Devices {9}------------------------------------------------ {10}------------------------------------------------ {11}------------------------------------------------ {12}------------------------------------------------ Overall, design verification testing was 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 Dental Handpiece retains the substantially equivalent profile as the predicate devices of SMARTmatic (K163239) and ANTHOGYR Contra angles and Handpieces (K093894). - ISO 3964 (2016) "Dental Handpieces – Coupling dimensions" (Recognition List Number: 003 Effective Date: 05/03/1999) - 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 instruments" ● {13}------------------------------------------------ ## 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 devices of SMARTmatic (K163239), ANTHOGYR Contra angles and Handpieces (K093894). #### Biocompatibility Testing In accordance with ISO 10993-1: 2009, Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process, the proposed Dental Handpiece is categorized as a device appropriate for biocompatibility testing required for devices with Tissue/bone/dentin contact with limited <24 hour contact duration. This is the same testing classification of the biocompatibility evaluation as the predicates SMARTmatic(K163239) and ANTHOGYR Contra angles and Handpieces (K093894) The biocompatibility testing of the Dental Handpiece listed below has been conducted in 2019 in order to ensure FDA's latest consensus standards with respect to biocompatibility evaluations are met for the proposed device. The favorable biocompatibility test results drawn in 2019 testing confirms the biocompatibility profile of the Dental Handpiece. - 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) ### Design Verification and Validation Testing Design Verification and Validation testing were performed to verify that the proposed Dental Handpiece meets the pre-determined design requirements and demonstrated design input matched with design outputs. Risk management assessment was conducted and appropriate risk mitigation measures were implemented including verifications of the effectiveness of the implemented risk control measures to mitigate the risks identified within the risk management process (per ISO 14971:2012 Medical Devices - Application of Risk Management to Medical Devices). - Rotational Speed Testing ● - Noise Testing - Water Supplying Testing - Light Testing - Operation Testing - . Appearance Testing The favorable results of the biocompatibility, design verification performance, and validation testing demonstrate conformance of the proposed Dental Handpiece to the applicable, recognized standards of FDA. The testing results further demonstrate the substantially equivalent profile as {14}------------------------------------------------ the predicate device, the proposed device are subject to the same applicable test standards under FDA's recognized standards including ISO 10993-1 (2009). ### VII. 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 predicates of SMARTmatic (K163239) and ANTHOGYR Contra angles and Handpieces (K093894). The favorable results of the aforementioned design verification and performance testing demonstrate conformance to the appropriate standards pertinent to dental handpieces, and demonstrate substantial equivalence to the identified predicate devices.