(686 days)
No
The summary describes a standard dental operative unit with electronic controls and software for chair movements and water functions, but there is no mention of AI or ML capabilities.
No.
The device description states its purpose is to supply power and serve as a base for other dental devices and accessories by providing air, water, vacuum, and low voltage electrical power. It is not directly involved in treating a disease or condition.
No
The device description indicates that the N2 unit is 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. It is a dental operative unit that includes a treatment chair, dentist and assistant elements, and a dental light. Its function is to support other dental equipment and procedures, not to diagnose medical conditions or diseases.
No
The device description explicitly states it is an "AC-powered dental operative unit with accessories" and includes physical components like a treatment chair, dentist element, assistant element, and dental light. While it mentions electronically controlled chair movements and water unit functions with software, the core device is a hardware system. The software validation section also refers to "Software Contained in Medical Devices," indicating the software is part of a larger hardware device, not a standalone software product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is "intended to supply power to and serve as a base for dental devices and accessories." It facilitates dental procedures but does not perform tests on samples taken from the human body to provide diagnostic information.
- Device Description: The description details a dental operative unit providing power, air, water, vacuum, and electrical power to dental instruments. It includes a chair, elements, and a light. This aligns with equipment used during dental procedures, not for in vitro testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or providing diagnostic results based on such analysis.
The device is a piece of dental equipment used in a clinical setting to support dental procedures.
N/A
Intended Use / Indications 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.
Product codes
EIA
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.
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained dental professionals, dentists and/or dental assistants.
dental clinic environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The performance tests were conducted as bench test and the test results met the pre-set criteria.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
1
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
2
Indications for Use
510(k) Number (if known) K211556
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) | |
|---|---|
| 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
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.
Page 1 of 6
4
" 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
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.
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 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. | K3 is intended to supply power to and serve | |
| as a base for dental devices and accessories. | ||
| This device 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. | ||
| 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 & Utility | ||
| Supply | 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 vibration
power, table height, Patient Chair
Positioning, timer,
Handpiece function, LED Display | - Accessories: 3-way syringe - Control of water supply, scaler vibration
power, 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, Waterline
power switch, Control of water, Light
On/Off, Position memories, Spittoon wash | - Accessories: Saliva Ejector (Small, Large),
3-way Syringe - Light On/Off, Cup/ Spittoon water
Dispenser, Changing the Settings, Position
memories |
| Main
Components | Chair, Unit, Table, Seat, Stool, Monitor
Arm, 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 of
water and air | Uses pneumatically controlled valves to
water control the flow of air and water.
On/off and intensity controlled by foot
pedal. | Uses pneumatically controlled valves to
water control the 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 16954
Waterline: Routine (Daily), Shock
treatment (2weeks), Water Flushing (each
patient) | -- |
| Warmer | Heating Method: Heating Coil
Storage Container Temperature:
Max 40℃
Water Temperature: Average 33~35℃
Temperature Sensor: Bi-metallic
Thermostats | -- |
| Water
Sanitation
System | 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 |
| Electromagnetic
Compatibility | Complied with IEC 60601-1-2 | Complied with IEC 60601-1-2 |
| Patient
contacting
components | Seat: Polyvinyl Chloride, Polyester
Waterline: Polyurethane resin, Polyamide
66 + GF25%, Stainless steel, C3604, Silicon
Airline: Polyurethane, Polyamide 66 +
GF25%, Aluminum Alloy
HVE: Aluminum Alloy
3-Way Syringe: C3604 (Chromium
plated), Aluminum Alloy
Saliva Ejector: Aluminum Alloy
Warmer: Stainless Steel 304 (Chromium
plated)
Water block : C3604 (Chromium plated) | -- |
| Principle of
Operation | The chair is operated, the rising S/W is
activated and the chair is hydraulically
operated.
The 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. | The chair is operated, the rising S/W is
activated and the chair is hydraulically
operated.
The 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. |
6
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
7
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
8
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.