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.

Device Description

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a Class I dental handpiece, meaning it is seeking to demonstrate substantial equivalence to legally marketed predicate devices, rather than proving a specific performance metric against acceptance criteria. Therefore, the information requested in your prompt (acceptance criteria, study details, sample sizes, expert involvement, etc.) is not explicitly available in the provided document in the way it would be for a novel device undergoing clinical trials.

The document focuses on demonstrating that the new dental handpiece is substantially equivalent to existing predicate devices (SMARTmatic (K163239) and ANTHOGYR Contra angles and Handpieces (K093894)). Substantial equivalence is primarily proven by showing similar indications for use and technological characteristics, and by conforming to recognized standards.

Here's an analysis of the provided information relative to your request:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria in the sense of specific thresholds for a novel device's performance metrics (e.g., a specific accuracy or sensitivity). Instead, it lists design verification and performance data tests that were conducted to confirm the device meets pre-determined design requirements and conforms to recognized standards. The "reported device performance" is generally stated as "favorable test results" or "demonstrates conformance."

Here's a table based on the information available, interpreting "acceptance criteria" as meeting the relevant standard and "reported device performance" as the outcome of the testing:

Acceptance Criteria (Interpreted as Conformance to Standard)	Reported Device Performance (as stated in document)
Biocompatibility: Conformance to ISO 10993-1:2009 for tissue/bone/dentin contact with limited <24 hour contact duration	Favorable biocompatibility test results, confirming the biocompatibility profile.
Rotational Speed Testing: Meet pre-determined design requirements	Favorable results, demonstrating conformance.
Noise Testing: Meet pre-determined design requirements	Favorable results, demonstrating conformance.
Water Supplying Testing: Meet pre-determined design requirements	Favorable results, demonstrating conformance.
Light Testing: Meet pre-determined design requirements	Favorable results, demonstrating conformance.
Operation Testing: Meet pre-determined design requirements	Favorable results, demonstrating conformance.
Appearance Testing: Meet pre-determined design requirements	Favorable results, demonstrating conformance.
Risk Management: Conformance to ISO 14971:2012	Appropriate risk mitigation measures implemented and verifications of effectiveness conducted.
Handpiece and Motors Conformance: ISO 14457 (2017)	Compliant with the same standards for dentistry handpiece and motors.
Shanks Conformance: ISO 1797 (2017)	Compliant with the same standards of dentistry shanks.
Coupling Dimensions Conformance: ISO 3964 (1982)	Compliant with the same standards of dentistry coupling dimensions.
Sterilization: Conformance to ISO 17665-1	Conform to the same standards for user sterilization.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes for the "design verification and performance data" tests (e.g., for rotational speed, noise, water supplying, etc.). It only states that these tests were performed.

For Biocompatibility, it states the testing was conducted in 2019, implying prospective testing for the proposed device. The country of origin for the data is not explicitly stated for individual tests, but the manufacturer is Micro-NX Co., Ltd. from the Republic of Korea, suggesting the testing likely occurred there or was contracted to testing facilities globally.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable to the type of submission described. This is a 510(k) for a dental handpiece, not an AI/imaging device requiring expert interpretation for ground truth establishment. The "ground truth" here is adherence to engineering and safety standards, not diagnostic accuracy.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically used in clinical trials or studies where human interpretation of medical data is being evaluated, particularly with AI. This document pertains to the physical and functional characteristics of a medical device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is for a dental handpiece, not an AI or imaging diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is for a dental handpiece, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this device, the "ground truth" is defined by established engineering standards, material safety standards, and functional performance benchmarks (e.g., specific rotational speeds, noise limits, water flow rates). These are objective measurements against recognized international and national standards (ISO, FDA recognized standards).

8. The sample size for the training set

Not applicable. This is for a dental handpiece, not a machine learning model.

9. How the ground truth for the training set was established

Not applicable. This is for a dental handpiece, not a machine learning model.

Summary

{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

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.

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 finaldental bur
Middle GearAssembly	Transmitting the rotational force from being Housing Assembly alsodelivering 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 HousingAssembly, and the Button Assembly is assembled
HeadAssembly	The component that is assembled Spindle Assembly, Middle Gear Assembly,Button Assembly, Head Assembly
HousingAssembly	Transmits the torque received from Joint Assembly to Middle Gear Assembly
JointAssembly	Transmits the torque received from the motor to the Housing Assembly
Inner Handle	Case to fix Joint Assembly
Planetary GearAssembly	The component that is assembled Housing Assembly, Joint Assembly, InnerHandle
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 thehandpiece head
Angle Handle	The case of Planetary Gear Assembly, Optic, HeadAssembly
Angle BodyAssembly	The case is installed in Handle Assembly and has two parts where the lightpassing through the optical fiber comes out and the part where the Pipe Clipcan 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 andoutside 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 BodyAssembly	The case is installed in Handle Assembly and has two parts where the lightpassing through the optical fiber comes out and the part where the pipe clip canbe fixed
Angle Handle	The case of Planetary Gear Assembly, Optic, HeadAssembly
Irrigation PipeAssembly	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 HandleAssembly	An outer case that is assembled Nose Cap, Angle Handle.
Angle Handle	An outer case assembled the back part of Cam Handle Assembly
Irrigation PipeAssembly	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 thehandpiece head
-------	----------------------------------------------------------------------------------------------------

V. INDICATIONS FOR USE/INTENDED USE

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.

ComparisonCategory	Proposed Device:Dental Handpiece	PredicateDevice:SMARTmatic(K163239)	PredicateDevice:ANTHOGYRContra angles andHandpieces(K093894)	SubstantialEquivalenceAssessments
Intended Use/Indicationsfor Use	Dental Handpiecewith models ofSG200, SG200L,SA100L, SA100R,CA100L, andCA100R are intendedfor the removal ofcarious material,reducing of hard toothstructure, cavity andcrown preparations,root canalpreparations, removalof fillings, processingand finishing toothpreparations and	The SMARTmatichandpieces areintended for theremoval of cariousmaterial, reducingof hard toothstructure, cavityand crownpreparations, rootcanal preparations,removal of fillings,processing andfinishing toothpreparations,restorations, andfor polishing teeth	ANTH-OGYR'Sfully autoclavablecontra-anglesImplantologyImpulsion aredevices intendedfor a widerange of dentalproceduresincluding:Implant surgerysuch as perforatingthe bone, tappingandthreadingprocedures	Intended use andindications for useare the samebetween DentalHandpiece and thepredicate deviceof SMARTmatichandpieces, for theremoval of cariousmaterial, reducingof hard toothstructure, cavityand crownpreparations, rootcanal preparations,removal of
	restorations forpolishing teeth.In addition, DentalHandpiece withmodels of SG200,SG200L are alsointended for implantsurgery such asperforating the bone,tapping andthreading procedures.Dental Handpiece isdesigned for use by atrained professionalin the field of generaldentistry.	They are designedfor use by a trainedprofessional in thefield of generaldentistry.	fillings,processing andfinishing toothpreparations, andrestorations forpolishing teeth.The intended useof the predicate,ANTHOGYR forimplant surgerysuch asperforating thebone, tapping andthreadingprocedures is thesame as theintended use ofMicro-NX dentalhandpiece formodels of SG200,SG200L.
FunctionalPrinciple	Through the micromotor connected tothe dental treatmentunit, the straight andcontra-anglehandpieces equippedwith a handpiececonnection accordingto ISO 3964(Dentistry - Couplingdimensions forhandpiece connectors- ISO 3964:1982)receive the energy,the cooling water andair for treatment andthe light forillumination theoperating area.	Through the micromotor connected tothe dentaltreatment unit, thestraight andcontra-anglehandpiecesequipped with ahandpiececonnectionaccording to ISO3964 (Dentistry -Couplingdimensions forhandpiececonnectors - ISO3964:1982) receivethe energy, thecooling water andair for treatmentand the light forillumination theoperating area.	Through the micromotor connected tothe dentaltreatment unit, thestraight andcontra-anglehandpiecesequipped with ahandpiececonnectionaccording to ISO3964 (Dentistry -Couplingdimensions forhandpiececonnectors - ISO3964:1982) receivethe energy, thecooling water andair for treatmentand the light forillumination theoperating area.	Same FunctionalPrinciple
Dimensions	Head size-Height: Up to 14mmHead size-Diameter:Up to 9mmLength: Up to95.80mm	Head size-Height:Up to 13.6 mmHead size-Diameter: Up to9.8 mmLength: Up to 93.4mm	Head size-Height:Up to 13.02mmHead size-Diameter: Up to10.07 mmLength: Up to104.84mm	The head size,height, anddiameter ofMICRO-NXDental Handpieceare broadly inalignment with the
				dimensions of the
				predicate,
				SMARTmatic
				handpiece. The
				minute differences
				in the identified
				dimensions do not
				raise different
				questions of safety
				and effectiveness.
Directpatient-contactingportions ofthe device	All materials forMICRO-NX DentalHandpiece models arelisted in the rawmaterial table belowincluding chemicalcomposition of thewaterlines and thepatient-contactingportions of thedevice.Biocompatibleaccording to ISO10993-1 (Biologicalevaluation of medicaldevices - Part 1:Evaluation andtesting within a riskmanagement system -ISO 10993-1:2009)	All materials forthe SMARTmaticmodels are listedin the tables belowincluding chemicalcomposition of thewaterlines and thepatient-contactingportions of thedevice.Biocompatibleaccording to ISO10993-1(Biologicalevaluation ofmedical devices -Part 1: Evaluationand testing withina risk managementsystem - ISO10993-1:2009)	Biocompatibleaccording to ISO10993-1(Biologicalevaluation ofmedical devices -Part 1: Evaluationand testing withina risk managementsystem - ISO10993-1:2009)	All patientcontactingmaterials ofMICRO-NXHandpiece havebeen tested per thesame standards ofISO 10993-1.Given thefavorablebiocompatibilitytest results, thedifferences inpatient contactingmaterials do notraise differentquestions in termsof safety andeffectiveness.
Indirectpatient-contactingportions ofthe device(water / airlines)	All materials forMICRO-NX DentalHandpiece models arelisted in the tablesbelow includingchemical compositionof the waterlines andthe patient-contactingportions of thedevice.Biocompatibleaccording to ISO10993-1 (Biologicalevaluation of medicaldevices - Part 1:Evaluation andtesting within a riskmanagement system -ISO 10993-1:2009)	All materials forthe SMARTmaticmodels are listedin the tables belowincluding chemicalcomposition of thewaterlines and thepatient-contactingportions of thedevice.Biocompatibleaccording to ISO10993-1(Biologicalevaluation ofmedical devices -Part 1: Evaluationand testing withina risk managementsystem - ISO10993-1:2009)	Biocompatibleaccording to ISO10993-1(Biologicalevaluation ofmedical devices -Part 1: Evaluationand testing withina risk managementsystem - ISO10993-1:2009)	All in-directpatient contactingmaterials ofMICRO-NXHandpiece havebeen tested per thesame standards ofISO 10993-1.Given thefavorablebiocompatibilitytest results, thedifferences inpatient contactingmaterials do notraise differentquestions of safetyand effectiveness.
		system - ISO10993-1:2009)
ChuckDesign	Push Button, LatchType	Push Button,Twist-tensionChuck, Snap-on &Screw-in	Push Button, LatchType	The chuck designof MICRO-NXDental Handpieceis the same as thepredicate,ANTHOGYR(K093894).
Speed Range(RPM's)	Up to 40,000 rpm	Up to 40,000 rpm	Up to 40,000 rpm	Same SpeedRange
ConformanceStandards(Handpiecesand Motors)	ISO 14457 (Dentistry- Handpieces andmotors - ISO14457:2012)	ISO 14457(Dentistry -Handpieces andmotors - ISO14457:2012)	ISO 14457(Dentistry -Handpieces andmotors - ISO14457:2012)	Compliant withthe same standardsfor dentistryhandpiece andmotors.
ConformanceStandards(Shanks)	ISO 1797 (2017)"Dentistry - Shanksfor rotary andoscillatinginstruments"	ISO 1797-1 (2011)"Dentistry -Shanks for rotaryinstruments - Part1: Shanks made ofmetals"	ISO1797-1(1995)"Dental rotatoryinstruments -Shanks - Par 1:Shanksmade of metal"	Compliant withthe same standardsof dentistryshanks.
ConformanceStandards(CouplingDimensions)	ISO 3964 (Dentistry -Coupling dimensionsfor handpiececonnectors - ISO3964:1982)	ISO 3964(Dentistry -Couplingdimensions forhandpiececonnectors - ISO3964:1982)	ISO 3964(Dentistry -Couplingdimensions forhandpiececonnectors - ISO3964:1982)	Compliant withthe same standardsof dentistrycouplingdimensions.
Sterilization	Sterilisable accordingto ISO 17665-1(Sterilization ofhealth care products -Moist heat - Part 1:Requirements for thedevelopment,validation and routinecontrol of asterilization processfor medical devices	Sterilisableaccording to ISO17665-1(Sterilization ofhealth careproducts - Moistheat - Part 1:Requirements forthe development,validation androutine control of a	Sterilisableaccording to ISO17665-1(Sterilization ofhealth careproducts - Moistheat - Part 1:Requirements forthe development,validation androutine control of a	Conform to thesame standards foruser 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.

Regulation Number and Section

§ 872.4200 Dental handpiece and accessories.

(a)
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.(b)
Classification. Class I.