N2 is intended to supply power to and serve as a base for dental devices and accessories. This includes a dental chair and is intended for use in the dental clinic environment and is designed for use by trained dental professionals, dentists and/or dental assistants.

Device Description

The N2 is an AC-powered dental operative unit with accessories, intended to supply power to and serve as a base for dental devices and accessories by providing air, water, vacuum and low voltage electrical power to dental instruments and dental handpieces. It includes a treatment chair, dentist element, assistant element and a dental light as offering several additional options and electronicallycontrolled chair movements with software and water unit functions.

AI/ML Overview

This document describes the N2, a dental operative unit, and its substantial equivalence to a predicate device (K183347), K3. The submission focuses on non-clinical testing for safety and performance rather than AI-driven image analysis. Therefore, many of the requested fields regarding AI performance, such as sample size for test/training sets, data provenance, number and qualification of experts, adjudication methods, MRMC studies, and ground truth types, are not applicable in this context.

The document details the device's technical characteristics, intended use, and indicates that no clinical studies were deemed necessary. The acceptance criteria and "reported device performance" are primarily demonstrated through compliance with various international standards and specific bench tests, rather than metrics like sensitivity, specificity, or accuracy which would be typical for an AI-enabled diagnostic device.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard/Test)	Reported Device Performance (Compliance/Result)
Biocompatibility Testing
FDA Guidance Document	Evaluation conducted in accordance with FDA Guidance.
ISO 10993-1 (Biological Evaluation)	Evaluation conducted in accordance with ISO 10993-1.
ISO 10993-5 (Cytotoxicity)	Testing performed.
ISO 10993-10 (Skin sensitization, Oral Mucosa Irritation, or Skin Irritation)	Testing performed.
Cleaning and Sterilization Validation
FDA Guidance for Reprocessing Medical Devices	Cleaning of 3-way syringe tip validated according to FDA Guidance.
ISO 17665-1, 2 (Sterilization)	Sterilization testing for steam sterilization performed, acceptable sterility assurance level (10⁻⁶) achieved for reusable 3-way Syringe.
ISO 16954:2015 (Dental Unit Waterline Biofilm Treatment)	Cleaning/disinfection method effectively cleaned the waterline. Routine (Daily) and shock treatment (2 weeks) performed and verified.
Electrical Safety and EMC
IEC 60601-1:2005 + A1:2012 (Basic Safety)	Complied with IEC 60601-1.
IEC 80601-2-60:2012 (Dental Equipment Safety)	Complied with IEC 80601-2-60.
IEC 60601-1-2:2014 (EMC)	Complied with IEC 60601-1-2.
Usability Testing
IEC 60601-1-6 Edition 3.1 2013-10 (Usability)	Usability testing conducted.
IEC 62366:2015 (Usability Engineering)	Usability testing conducted.
Software Validation
FDA Guidance for Software in Medical Devices	Software (firmware, MODERATE level of concern) designed, developed, verified, and validated according to a software development process. Documentation provided.
Performance Test (Bench Test)	Performed, and test results met pre-set criteria. (Specific criteria not detailed in this summary, but generally implies functional performance as an operative dental unit, e.g., air/water pressure, chair movements, etc., as per the comparison table and functional description). The differences in Water Pressure, Patient Load, Chair Height, Back Rest, and unit type compared to the predicate device do not affect substantial equivalence, and safety was verified.

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

This information is not applicable as the submission describes a physical dental operative unit, not an AI/software device that processes medical image data or other patient-specific data for diagnostic or prognostic purposes. The "testing" refers to bench testing and compliance with electrical, mechanical, and safety standards for the device itself.

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 is not applicable. Ground truth, in the context of expert consensus, is typically established for diagnostic tasks where human interpretation is the gold standard. For this device, "ground truth" would relate to the physical and functional parameters meeting engineered specifications and safety standards, validated through direct measurement and compliance testing (e.g., measuring current, pressure, chair movement ranges).

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

This is not applicable. Adjudication methods are used to resolve discrepancies in expert interpretations, which is not relevant for the testing described here.

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

This is not applicable. MRMC studies are conducted for systems that assist human readers in tasks like image interpretation. The N2 is a dental operative unit, not an AI-assisted diagnostic or interpretative tool.

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

This is not applicable. The N2 is a physical device with some electronic controls (firmware), not a standalone algorithm.

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

The "ground truth" for this device's performance is primarily established by:

Engineering Specifications: The pre-set criteria for bench tests, electrical safety, and mechanical performance are based on design specifications and industry standards.
Regulatory Standards: Compliance with international standards such as IEC 60601-1, IEC 80601-2-60, ISO 10993, ISO 17665, and ISO 16954 forms the basis of "truth" for safety and essential performance.
Manufacturer Recommendations: For cleaning/sterilization, the validation is against the manufacturer's recommended protocols.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of machine learning for this device. The software validation refers to standard software development, verification, and validation (V&V) processes for firmware, not AI model training.

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

This is not applicable for the reasons stated above.

In summary, the provided document describes a 510(k) submission for a dental operative unit, which is a physical device. The "study" mentioned refers to non-clinical bench testing and compliance with various international electrical, mechanical, safety, and biocompatibility standards to demonstrate substantial equivalence to a predicate device. It is not an AI-enabled diagnostic or assistive device, so many of the requested fields regarding AI performance evaluation are irrelevant.

Summary

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April 5, 2023

MegaGen Implant Co., Ltd. Jae Ho Lee Research Engineer 45, Secheon-ro, 7-gil, Dasa-eup, Dalseong-gun, Daegu REPUBLIC OF KOREA

Re: K211556

Trade/Device Name: N2 Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit And Accessories Regulatory Class: Class I, reserved Product Code: EIA Dated: March 12, 2023 Received: March 13, 2023

Dear Jae Ho Lee:

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.

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

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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 (QS) 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 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).

Sincerely,

Michael E. Adjodha -S

Michael E. Adjodha, M.ChE. 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

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Indications for Use

510(k) Number (if known) K211556

Device Name N2

Indications for Use (Describe)

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)

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V. 510(k) Summary - K211556

This 510(k) Summary is being submitted in accordance with the requirements of 21 CFR 807.92.

Date: Apr, 03, 2023

1. Applicant / Submitter

MegaGen Implant Co., Ltd. 45, Secheon-ro, 7-gil, Dasa-eup, Dalseong-gun, Daegu, Republic of Korea Tel: +82-53-222-2828

2. Submission Correspondent

Jae Ho Lee MegaGen Implant Co., Ltd. 45, Secheon-ro, 7-gil, Dasa-eup, Dalseong-gun, Daegu, Republic of Korea Tel: +82-53-222-3856 Fax: +82-53-289-3414 Email: ra5@imegagen.com

3. Device

Trade Name: N2
Common Name: Unit, Operative Dental
Classification Name: Dental Operative unit and Accessories
Product Code: EIA
Regulation number: 21 CFR 872.6640
Device class: I

4. Predicate Device

510(k) number: K183347
Product name: K3

5. Description

l General
The N2 is a dental treatment unit tested in accordance with IEC 80601-2-60. This product is used in dentistry only and may only be used by trained medical personnel and trained professional in the field of general dentistry.

. Technological Characteristics

Page 1 of 6

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" Type

The subject device has two types, Cart type and Mount type which consists of chairs, unit, table, seat, stool, 3-way syringe, monitor arm, foot control and console. Each type has Type B depending on the design of cup filling water and a cuspidor for rinsing the patient's mouth. User can select Type A and Type B.

י Principle of Operation

The chair is operated, the rising S/W is activated and the chair is hydraulically operated. The dental device (e.g. handpiece) is operated, pressing the foot control pedal opens the air supply valve to rotate the handpiece turbine. The 3-way syringe is operated by air pressure or electronic circuit S/W.

[Note] The assist device, such as dental handpiece and scaler is not included with this subject device N2. These optional device and accessories are not supplied by manufacturer, and are installed by the end-users using the recommended installation method described in the user manual provided by the manufacturers of these accessories. Also, the HVE Tip and Saliva Ejector Tip are not include with the subject device, N2 and not provided by the manufacturer.

6. Intended Use

The N2 is intended to supply power to and server as a base for dental devices and accessories by providing air, water, vacuum and low voltage electrical power to dental instruments and dental handpiece.

7. Indications for Use

8. Basis for Substantial Equivalence

The N2 is substantially equivalent to the predicate device in terms of intended use, technical & performance characteristic, electrical power, design and function.

Also, the Indications for Use for the subject devices is identical to the primary predicate, K183347.

The performance testing and data performed on the subject device demonstrate that the difference in external design and some technological characteristics compared to the predicate device does not raise any new questions of safety and effectiveness.

Based on the comparison charts below and test results provided in this submission, we conclude that the subject device is substantially equivalent to the predicate device.

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	Subject Device	Predicate Device
Manufacturer	MegaGen Implant Co., Ltd.	Osstem Implant Co., Ltd.
510(k) number	K211556	K183347
Indications forUse	N2 is intended to supply power to and serveas a base for dental devices and accessories.This includes a dental chair and is intendedfor use in the dental clinic environment andis designed for use by trained dentalprofessionals, dentists and/or dentalassistants.	K3 is intended to supply power to and serveas a base for dental devices and accessories.This device includes a dental chair and isintended for use in the dental clinicenvironment and is designed for use bytrained dental professionals, dentistsand/or dental assistants.
Product Name	N2	K3
Product Code	EIA	EIA
Model Type	Mount Type, Cart Type	Mount Type, Cart Type
Unit Type	A type, B type	Sing type
Power & UtilitySupply	AC 100-120/220-240V,50/60Hz, compressed air and water	AC 100-120/220-240V,50/60Hz, compressed air and water
Table	- Accessories: 3-way syringe- Control of water supply, scaler vibrationpower, table height, Patient ChairPositioning, timer,Handpiece function, LED Display	- Accessories: 3-way syringe- Control of water supply, scaler vibrationpower, table height, patient position,System Power, Film viewer,Patient Chair Positioning,Light On/Off, Handpiece function, Timer,Mode Selection, LED Display
Assist Table	- Accessories: Saliva Ejector, HVE (Small,Large), 3-way Syringe- Second Assi Power Switch, Waterlinepower switch, Control of water, LightOn/Off, Position memories, Spittoon wash	- Accessories: Saliva Ejector (Small, Large),3-way Syringe- Light On/Off, Cup/ Spittoon waterDispenser, Changing the Settings, Positionmemories
MainComponents	Chair, Unit, Table, Seat, Stool, MonitorArm, Operation table	Chair, Unit, Table, Seat, Stool,Monitor Arm, Hanaro Console(Note: K3 Cart* model applied ONLY)
Syringe	3-way syringe	3-way syringe
Control ofwater and air	Uses pneumatically controlled valves towater control the flow of air and water.On/off and intensity controlled by footpedal.	Uses pneumatically controlled valves towater control the flow of air and water.On/off and intensity controlled by footpedal.
Water System	City water supply	City water supply
Cleaning	Waterline cleaning according to ISO 16954Waterline: Routine (Daily), Shocktreatment (2weeks), Water Flushing (eachpatient)	--
Warmer	Heating Method: Heating CoilStorage Container Temperature:Max 40℃Water Temperature: Average 33~35℃Temperature Sensor: Bi-metallicThermostats	--
WaterSanitationSystem	Distilled water container added.	Distilled water container added
Suction	HVE (High volume evacuator)Saliva Ejectors	HVE (High volume evacuator)Saliva Ejectors
	Second Assi
Air Pressure	500kPa(min) / 750kPa(max)	500kPa(min) / 750kPa(max)
Water Pressure	245 kPa(max)	250kPa(min) / 600(kPa)
Patient Load	Max. 150 kg	Max. 135kg
Chair Height	Max. 700±10mm,Min. 400±10mm	Max. 795±10mm,Min. 365±10mm
Back Rest	0°±3° to 68°±3°	0°±5° to 67°±5°
Head Rest	-50° to +14°±2°	-10° to 45°
Rift Motor	Hydraulic electromotor	Hydraulic electromotor
Dental light	Available	Available
Foot control	standard	standard
Electrical Safety	Complied with IEC 60601-1	Complied with IEC 60601-1
ElectromagneticCompatibility	Complied with IEC 60601-1-2	Complied with IEC 60601-1-2
Patientcontactingcomponents	Seat: Polyvinyl Chloride, PolyesterWaterline: Polyurethane resin, Polyamide66 + GF25%, Stainless steel, C3604, SiliconAirline: Polyurethane, Polyamide 66 +GF25%, Aluminum AlloyHVE: Aluminum Alloy3-Way Syringe: C3604 (Chromiumplated), Aluminum AlloySaliva Ejector: Aluminum AlloyWarmer: Stainless Steel 304 (Chromiumplated)Water block : C3604 (Chromium plated)	--
Principle ofOperation	The chair is operated, the rising S/W isactivated and the chair is hydraulicallyoperated.The handpiece is operated, pressing thefoot control pedal opens the air supplyvalve to rotate the handpiece turbine.The 3-way syringe is operated by airpressure or electronic circuit S/W.	The chair is operated, the rising S/W isactivated and the chair is hydraulicallyoperated.The handpiece is operated, pressing thefoot control pedal opens the air supplyvalve to rotate the handpiece turbine.The 3-way syringe is operated by airpressure or electronic circuit S/W.

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1. Similarities

The subject device has the same characteristics compared to the predicate device for the following:

Indications for Use, model type, power & utility supply, main components, syringe, control of water and air, water system, water sanitation system, suction, Rift motor, Dental Light, Foot Control, Electrical Safety, Electromagnetic Compatibility, principle of operation, Assist Table Function, Warmer specification, cleaning.

2. Differences

The subject device has different characteristics for the following compared to the primary predicate device.

Water Pressure, Patient Load, Chair Height, Back Rest, Head Rest -
- Some technical specifications are different compared to the predicate device, but this does not affect substantial equivalence since these differences only include minor differences in specification ranges.
-Unit Type The subject device has the Mount type and Cart Type similar to the predicate device, but each type of

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subject device is divided into Type B depending on the design of cup filler for filling water and a cuspidor for rinsing the patient's mouth.

The unit type of subject device is different compared to the predicate device but this does not affect substantial equivalence since the variety of types widens the range of choices according to user preferences and there is no electrical or performance difference affecting the performance of the device.

-Waterline Cleaning Methods Routine (Daily) and shock treatment were performed as recommended by the manufacturer and verified according to ISO 16954.

-Tissue contacting material Tissue contacting components were included in biocompatibility tests conducted and there is no affect on biological safety.

Discussion

The proposed N2 and predicate device are similar in all the items in the comparison chart except the Water Pressure, Patient Load, Chair Height, Back Rest, unit type, Waterline Cleaning Methods. These differences do not affect substantial equivalence, also the safety was verified with testing according to IEC 60601-1 and IEC 80601-2-60 for the above differences, the performance test (Bench test) and Waterline Cleaning Validation were also conducted. The test result supports that the subject device is substantially equivalent to the predicate device and the differences do not affect substantial equivalence.

On the basis of the discussion above, it is concluded that the substantially equivalent to the predicate device.

9. Summary of Non-Clinical Testing

Biocompatibility Testing

The biocompatibility evaluation for N2 components was conducted in accordance with the FDA Guidance Document and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part1: Evaluation and Testing within a Risk Management Process ", as recognized by FDA.

The N2 components are considered surface medical device or external communicating device (intact skin or mucosal membrane) for a duration of less than 24 hours.

The biocompatibility testing was performed for Cytotoxicity, Skin sensitization, Oral Mucosa Irritation or Skin Irritation according to ISO 10993-5 and ISO 10993-10.

Cleaning and Sterilization Validation

A representative sample of the 3-way syringe components were used to validate the cleaning and sterilization. Cleaning of 3-way syringe tip was conducted according to FDA Guidance titled, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling". Sterilization testing for steam sterilization by the user has been performed in accordance ISO 17665-1, 2 to verify the sterility assurance level (10°). The 3way syringe tip was tested to validate that the components can withstand the steam sterilization process and that acceptable sterility is achieved using the recommended sterilization protocols. The sterilization testing was conducted according to ISO 17665-1:2006 and ISO 17665-2 and it validated that the reusable 3-way Syringe can be sterilized to reach an acceptable sterility assurance level.

Cleaning/disinfection validation was conducted on the subject device. Validation was conducted using the following standard:

. ISO 16954:2015 Dentistry-Test methods for dental unit waterline biofilm treatment

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Cleaning/disinfection method effectively cleaned the waterline.

Cleaning and Intermediate level disinfection vas provided representative of all Non-Critical Device components.

Electrical Safety and Electromagnetic compatibility (EMC)

The Electrical safety and Electromagnetic compatibility tests were performed in accordance with the following standards. Comprehensive performance testing has been conducted on the N2 in accordance FDA recognized standards. EMC testing was conducted in accordance with Standard EN/IEC 60601-1-2. Electrical, mechanical, and environmental safety testing according to Standard EN/IEC 60601-1 was performed. Usability testing was conducted in accordance with Standard EN/IEC 60601-1-6 and EN/IEC 62366.

. IEC 60601-1:2005 + A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
. IEC 80601-2-60:2012, Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
י IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
. IEC 60601-1-6 Edition 3.1 2013-10, Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance- Collateral Standard: Usability
. IEC 62366:2015, Medical device- Application of usability engineering to medical devices

Software Validation

Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

. The N2 contains MODERATE level of concern software (firmware). The software was designed and developed according to a software development process and was verified and validated.

Performance Test – Bench Test

The performance tests were conducted as bench test and the test results met the pre-set criteria.

10. Summary of Clinical Testing

No clinical studies are needed to characterize its performance and establish substantial equivalence.

11. Conclusion

Based upon the mentioned above data and comparison table, the N2 is substantially equivalent to the predicate device as described here in.

Regulation Number and Section

§ 872.6640 Dental operative unit and accessories.

(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.