N2

{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) 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. | 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 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. #### . Technological Characteristics 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. #### ● 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 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. #### 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 for<br>Use | N2 is intended to supply power to and serve as a<br>base for dental devices and accessories. This<br>includes a dental chair and is intended for use in<br>the dental clinic environment and is designed for<br>use by trained dental professionals, dentists and/or<br>dental assistants. | N2 is intended to supply power to and serve as a base<br>for dental devices and accessories. This includes a<br>dental chair and is intended for use in the dental clinic<br>environment and is designed for use by trained dental<br>professionals, dentists and/or dental assistants. | | Product Name | N2 | N2 | | Product Code | EIA | EIA | | Model Type | Mount B Type, Cart B Type,<br>Continental Type | Mount A Type, Cart A Type,<br>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),<br>Scaler<br>- Control of water supply, scaler vibration power,<br>table height, Patient Chair Positioning, timer,<br>Handpiece function, LED Display | - Accessories: 3-way syringe, Handpiece (high, low),<br>Scaler<br>- Control of water supply, scaler vibration power, table<br>height, Patient Chair Positioning, timer, Handpiece<br>function, LED Display | | Assist Table | - Accessories: Saliva Ejector, HVE (Small, Large), 3-<br>way Syringe<br>- Second Assi Power Switch, Waterline power<br>switch, Control of water, Light On/Off, Position<br>memories, Spittoon wash | - Accessories: Saliva Ejector, HVE (Small, Large), 3-way<br>Syringe<br>- Second Assi Power Switch, Waterline power switch,<br>Control of water, Light On/Off, Position memories,<br>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 of<br>water and air | Uses pneumatically controlled vales to water<br>control the flow of air and water.<br>On/off and intensity controlled by foot pedal. | Uses pneumatically controlled vales to water control<br>the flow of air and water.<br>On/off and intensity controlled by foot pedal. | | Water System | City water supply | City water supply | | Cleaning | Waterline cleaning according to ISO 16954<br>Waterline: Routine (Daily), Shock treatment<br>(2weeks),<br>Water Flushing (each patient) | Waterline cleaning according to ISO 16954<br>Waterline: Routine (Daily), Shock treatment (2weeks),<br>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 | | | | | | Water<br>Sanitation<br>System | Distilled water container added. | Distilled water container added. | | Suction | HVE (High volume evacuator), Saliva Ejectors,<br>Second Assi | HVE (High volume evacuator), Saliva Ejectors, Second<br>Assi | | 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°<br>- Posterior angle: less than 90± 5°<br>- Anterior angle: less than 150± 5°<br>- 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 | | Electromagnetic<br>Compatibility | 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 +<br>GF25%, Stainless steel, C3604, Silicon | - Waterline: Polyurethane resin, Polyamide 66 +<br>GF25%, Stainless steel, C3604, Silicon | | | - Airline: Polyurethane, Polyamide 66 + GF25%,<br>Aluminum Alloy | - Airline: Polyurethane, Polyamide 66 + GF25%,<br>Aluminum Alloy | | Patient<br>contacting<br>components | - HVE: Aluminum Alloy | - HVE: Aluminum Alloy | | | - 3-Way Syringe: C3604(Chromium plated),<br>Aluminum Alloy | - 3-Way Syringe: C3604(Chromium plated), Aluminum<br>Alloy | | | - Saliva Ejector: Aluminum Alloy<br>- Warmer: Stainless Steel 304 (Chromium plated) | - Saliva Ejector: Aluminum Alloy<br>- 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 activated<br>and the chair is hydraulically operated. | The chair is operated, the rising S/W is activated and<br>the chair is hydraulically operated. | | | The handpiece is operated, pressing the foot<br>control pedal opens the air supply valve to rotate<br>the handpiece turbine. | The handpiece is operated, pressing the foot control<br>pedal opens the air supply valve to rotate the<br>handpiece turbine. | | Principle of<br>Operation | The 3-way syringe is operated by air pressure or | The 3-way syringe is operated by air pressure or<br>electronic 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.