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 a dental treatment unit in accordance with IEC 80601-2-60 and designed for dental treatment of children and adults. 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.

The N2 is an AC-powered dental operative unit with accessories, 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 handpieces. It includes a treatment chair, dentist element, assistant element and a dental light as offering several additional options and electronically-controlled chair movements with software and water unit functions.

The subject device has three types, Cart type, Mount type and Continental type which consists of chairs, unit, table, seat, stool, 3-way syringe, monitor arm, foot control and console.

AI/ML Overview

The N2 dental operative unit is primarily evaluated against safety and performance standards for dental equipment and medical electrical equipment. As such, the acceptance criteria and study designs differ significantly from those for AI-powered diagnostic or prognostic devices.

Here's an analysis of the provided information, structured to address your specific points where applicable, and noting where the information is not relevant to this type of device:

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

For the N2 dental operative unit, the "acceptance criteria" are compliance with established international and FDA-recognized standards for electrical safety, electromagnetic compatibility, biocompatibility, cleaning/sterilization validation, and software validation. The reported device performance is that it complied with these standards.

Acceptance Criteria Category	Reported Device Performance	Reference Standard(s)
Biocompatibility	Not required; subject device uses same materials and patient-contacting parts as previously cleared predicate.	ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Cleaning and Sterilization Validation	Conducted on waterlines and 3-way syringe components. Verified that the reusable 3-way Syringe can be sterilized to reach an acceptable sterility assurance level.	ISO 16954: Dentistry-Test methods for dental unit waterline biofilm treatment. 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. ISO 17665-2: Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1. FDA Guidance: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.
Electrical Safety	Complied with standards.	IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. IEC 80601-2-60: Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment.
Electromagnetic Compatibility (EMC)	Complied with standards.	IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
Usability	Testing conducted in accordance with standards.	IEC 60601-1-6: Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance- Collateral Standard: Usability. IEC 62366: Medical device- Application of usability engineering to medical devices.
Software Validation	Software verification and validation testing conducted. Software designed and developed according to a software development process and verified/validated.	FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Performance Test – Bench Test	Test results met pre-set criteria.	Specific criteria for each bench test are not detailed but are implied to be part of the product development and verification process.

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

For this type of device, "test set" and "data provenance" don't apply in the way they do for AI/diagnostic devices. The evaluation of N2 relies on bench testing and compliance with recognized standards.

Bench Testing: This involves testing the physical device and its components in a controlled laboratory environment against specified parameters (e.g., electrical measurements, pressure limits, temperature control, mechanical movements). The "sample size" would typically be a representative number of units from a production batch or prototypes. The document doesn't specify the exact number of units tested for each standard, but it's understood to be sufficient for demonstrating compliance.
Data Provenance: This is not relevant. The testing is performed in accordance with international standards, and the results are primarily engineering and performance measurements, not patient data.

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 to the N2 device. "Ground truth" in the context of diagnostic performance (e.g., presence/absence of a disease) is established by expert consensus, pathology, or outcomes data. For a dental operative unit, the "ground truth" is adherence to engineering specifications and safety standards, which is verified through objective measurements and test procedures, not expert interpretation of clinical data.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies where human readers interpret medical images or data and their decisions need to be reconciled to establish a consensus ground truth. For equipment like N2, compliance is determined by passing objective tests against defined standards, not by human interpretation.

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. The N2 is a dental operative unit (a piece of hardware for dental procedures), not an AI-assisted diagnostic or therapeutic device that would involve human readers or image interpretation. Therefore, an MRMC study is completely irrelevant.

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

This is not applicable. The N2 device is not an algorithm. Its "standalone performance" is its ability to function safely and effectively as a dental operative unit, which is demonstrated through component testing, system integration testing, and compliance with the listed standards. The software components are for controlling the unit's functions, not for standalone diagnostic or analytical tasks.

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

As mentioned in point 3, the concept of "ground truth" in the context of expert consensus, pathology, or outcomes data is not applicable to this device. The "truth" for this device's safety and effectiveness is its conformance to established engineering and medical device standards through objective measurements and validated processes.

8. The sample size for the training set

This is not applicable. "Training set" refers to data used to train machine learning models. The N2 device is a hardware unit with embedded software for control; it does not utilize machine learning in its described function.

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

This is not applicable for the same reasons as point 8.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 21, 2024

MegaGen Implant Co., Ltd. % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059

Re: K240754

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 19, 2024 Received: March 20, 2024

Dear Dave Yungvirt:

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 (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, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K240754

Device Name N2

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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}------------------------------------------------

510(k) Summary

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

19 Mar 2024

Applicant / Submitter 1.

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

Hyo-Eun, Lee MegaGen Implant Co., Ltd. 45, Secheon-ro, 7-gil, Dasa-eup, Dalseong-gun, Daegu, Republic of Korea Tel: +82-53-222-3860 Fax: +82-53-289-3414 Email: ra7@imegagen.com

3. Device

N2 ● Trade Name:
Common Name: Unit, Operative Dental
Classification Name: Dental Operative unit and Accessories
Primary Product Code: EIA
Class I, 21 CFR 872.6640 ● Classification regulation:

Predicate Device: K211556 – N2 4.

5. Description

. General

. Technological Characteristics

● Type

The subject device has three types, Cart type, Mount type and Continental type which consists of chairs, unit, table, seat, stool, 3-way syringe, monitor arm, foot control and console.

● 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

{4}------------------------------------------------

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. Indication for use

7. 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, K211556.

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.

	Subject Device	Predicate Device
Manufacturer	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.
510(k) number	-	K211556
Indications forUse	N2 is intended to supply power to and serve as abase for dental devices and accessories. Thisincludes a dental chair and is intended for use inthe dental clinic environment and is designed foruse by trained dental professionals, dentists and/ordental assistants.	N2 is intended to supply power to and serve as a basefor dental devices and accessories. This includes adental chair and is intended for use in the dental clinicenvironment and is designed for use by trained dentalprofessionals, dentists and/or dental assistants.
Product Name	N2	N2
Product Code	EIA	EIA
Model Type	Mount B Type, Cart B Type,Continental Type	Mount A Type, Cart A Type,Mount B Type, Cart B Type,
Unit Type	B type	A type, B type
Power	AC 100-120/220-240V, 50/60Hz, compressed air	AC 100-120/220-240V, 50/60Hz, compressed air and
& Utility Supply	and water	water
Table	- Accessories: 3-way syringe, Handpiece (high, low),Scaler- Control of water supply, scaler vibration power,table height, Patient Chair Positioning, timer,Handpiece function, LED Display	- Accessories: 3-way syringe, Handpiece (high, low),Scaler- Control of water supply, scaler vibration power, tableheight, Patient Chair Positioning, timer, Handpiecefunction, LED Display
Assist Table	- Accessories: Saliva Ejector, HVE (Small, Large), 3-way Syringe- Second Assi Power Switch, Waterline powerswitch, Control of water, Light On/Off, Positionmemories, Spittoon wash	- Accessories: Saliva Ejector, HVE (Small, Large), 3-waySyringe- Second Assi Power Switch, Waterline power switch,Control of water, Light On/Off, Position memories,Spittoon wash
Main	Chair, Unit, Table, Seat, Stool, Monitor Arm,	Chair, Unit, Table, Seat, Stool, Monitor Arm, Operation
Components	Operation table	table
Syringe	3-way syringe	3-way syringe
Control ofwater and air	Uses pneumatically controlled vales to watercontrol the flow of air and water.On/off and intensity controlled by foot pedal.	Uses pneumatically controlled vales to water controlthe flow of air and water.On/off and intensity controlled by foot pedal.
Water System	City water supply	City water supply
Cleaning	Waterline cleaning according to ISO 16954Waterline: Routine (Daily), Shock treatment(2weeks),Water Flushing (each patient)	Waterline cleaning according to ISO 16954Waterline: Routine (Daily), Shock treatment (2weeks),Water Flushing (each patient)
	- Heating Method: Heating Coil	- Heating Method: Heating Coil
	- Storage Container Temperature: Max 40°C	- Storage Container Temperature: Max 40°C
Warmer	- Water Temperature: Average 33~35°C	- Water Temperature: Average 33~35°C
	- Temperature Sensor: Bi-metallic Thermostats	- Temperature Sensor: Bi-metallic Thermostats

WaterSanitationSystem	Distilled water container added.	Distilled water container added.
Suction	HVE (High volume evacuator), Saliva Ejectors,Second Assi	HVE (High volume evacuator), Saliva Ejectors, SecondAssi
Air Pressure	500kPa(min) / 750kPa(max)	500kPa(min) / 750kPa(max)
Water Pressure	245 kPa(max)	245 kPa(max)
Patient Load	Max. 150 kg	Max. 150 kg
Chair Height	Max. 700±10mm, Min. 400±10mm	Max. 700±10mm, Min. 400±10mm
Back Rest	0°±3° to 68°±3°	0°±3° to 68°±3°
Head Rest	- General angle: less than 0± 5°- Posterior angle: less than 90± 5°- Anterior angle: less than 150± 5°- Headrest angle: less than 180± 5°	-50° to +14°±2°

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
	- Seat: Polyvinyl Chloride, Polyester	- Seat: Polyvinyl Chloride, Polyester
	- Waterline: Polyurethane resin, Polyamide 66 +GF25%, Stainless steel, C3604, Silicon	- Waterline: Polyurethane resin, Polyamide 66 +GF25%, Stainless steel, C3604, Silicon
	- Airline: Polyurethane, Polyamide 66 + GF25%,Aluminum Alloy	- Airline: Polyurethane, Polyamide 66 + GF25%,Aluminum Alloy
Patientcontactingcomponents	- HVE: Aluminum Alloy	- HVE: Aluminum Alloy
	- 3-Way Syringe: C3604(Chromium plated),Aluminum Alloy	- 3-Way Syringe: C3604(Chromium plated), AluminumAlloy
	- Saliva Ejector: Aluminum Alloy- Warmer: Stainless Steel 304 (Chromium plated)	- Saliva Ejector: Aluminum Alloy- Warmer: Stainless Steel 304 (Chromium plated)
	- Water block: C3604 (Chromium plated)	- Water block: C3604 (Chromium plated)
	The chair is operated, the rising S/W is activatedand the chair is hydraulically operated.	The chair is operated, the rising S/W is activated andthe chair is hydraulically operated.
	The handpiece is operated, pressing the footcontrol pedal opens the air supply valve to rotatethe handpiece turbine.	The handpiece is operated, pressing the foot controlpedal opens the air supply valve to rotate thehandpiece turbine.
Principle ofOperation	The 3-way syringe is operated by air pressure or	The 3-way syringe is operated by air pressure orelectronic circuit S/W.

{5}------------------------------------------------

{6}------------------------------------------------

8. Summary of Non-Clinical Testing

The non-clinical testing data which are submitted, referenced, or relied on in this submission support demonstrating substantial equivalence.

Biocompatibility

The biocompatibility evaluation has been performed in accordance with International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. The additional biocompatibility testing is not required on the subject device since subject device has same material composition, manufacturing process and patient contacting parts as the previously cleared device, FDA-cleared predicate device, N2.

Cleaning and Sterilization Validation

Cleaning/disinfection validation was conducted on the waterlines of the subject device. Validation was conducted using the following standards:

ISO 16954:2015 Dentistry-Test methods for dental unit waterline biofilm treatment Cleaning and Intermediate level disinfection validation was provided representative of all Non-Critical Device components.
A representative sample of the 3-way syringe components were used to validate the cleaning and sterilization. Sterilization validating testing for steam sterilization by the user performed in accordance ISO 17665-1, 2 to verify the sterility assurance level (10-6). The sterilization validation 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. Also, the following FDA guidance documents were referred to:
Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff.

Electrical Safety and Electromagnetic compatibility (EMC)

The Electrical safety and Electromagnetic compatibility tests were performed in accordance with the following standards. Comprehensive 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 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 60601-1:2015, AMD1:2012, AMD2:2020, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
. IEC 80601-2-60:2019, Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
. 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.

{7}------------------------------------------------

Performance Test – Bench Test

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

9. Summary of Clinical Testing

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

10. 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.