(947 days)
Not Found
No
The description focuses on basic motor control and display functions, with no mention of AI/ML terms or capabilities.
Yes.
The device's intended uses, such as "cutting a tooth for cavity preparation, crown preparation, crown finishing, inlay, filing, polishing, prophylaxis and endodontic treatment," are all therapeutic procedures in dentistry.
No
This device is described as controlling motor speed and rotation for general dental applications like cutting, polishing, and endodontic treatment, which are therapeutic or procedural, not diagnostic.
No
The device description explicitly states it consists of a "micro motor controller and display panel," which are hardware components. The performance studies also include tests related to electrical safety and physical dimensions, further indicating a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "general dental applications" such as cutting teeth, preparing cavities, etc. These are procedures performed directly on the patient's body.
- Device Description: The description details a motor controller and display panel used to control a dental motor. This is a piece of equipment used in a clinical setting for physical procedures.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are designed to be used in vitro (outside the body) to examine specimens.
Therefore, the ELEC Master & ELEC Master Dual are dental devices used for treatment and procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
ELEC Master & ELEC Master Dual are intended for use in general dental applications such as: cutting a tooth for cavity preparation, crown preparation, crown finishing, inlay, filing, polishing, prophylaxis and endodontic treatment.
Product codes (comma separated list FDA assigned to the subject device)
EBW
Device Description
This product consists of a micro motor controller and display panel. Receiving rated input of AC 24V, this device controls motor speed, and rotation direction through the motor control circuit inside the controller. Motor speed, light and rotation direction functions can be set on the display panel.
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
general dental applications
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical bench tests were performed as followings:
- ISO 3964:2016 Dental Handpieces Coupling dimensions
- ISO 7494-1:2011 Dentistry Dental units -Part 1: General requirements and test methods
- ISO 14457:2017 Dentistry Handpieces and motors
- IEC 60601-1, IEC 60601-1-2: Electrical safety and EMC
- IEC80601-2-60:2012 : Particular Requirements For The Basic Safety And Essential Performance Of Dental Equipment
- IEC 62366 : Application of usability engineering to medical devices
Along with the above tests, sterilization validation, and software validation were also conducted. None of the testing demonstrated any design characteristics that violated the requirements of the standards or resulted in any safety hazard.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 5, 2023
Mgnewton Ltd. % Priscilla Chung Official Correspondent LK Consulting Group USA, Inc. 1150 Roosevelt, Suite 200 Irvine, California 92620
Re: K202963
Trade/Device Name: ELEC Master, ELEC Master Dual Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EBW Dated: April 7, 2023 Received: April 7, 2023
Dear Priscilla Chung:
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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Bobak Shirmohammadi -S
For Michael Adjodha, M.ChE.,COIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic. Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known)
Device Name ELEC Master & ELEC Master Dual
Indications for Use (Describe)
ELEC Master & ELEC Master Dual are intended for use in general dental applications such as: cutting a tooth for cavity preparation, crown preparation, crown finishing, inlay, filing, polishing, prophylaxis and endodontic treatment.
| 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) |
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3
510(k) Summary K202963
This summary of 510(k) is being submitted in accordance with requirements of 21 CFR Part 807.92
Date: SEP 29, 2020
1. 510K Applicant / Submitter:
MGNEWTON LTD. 472, Hanjanggun-ro, Jain-myeon, Gyeongsan-si, Gyeongsangbuk-do, Republic of Korea Tel: +82-53-214-6287 Fax: +82-70-7469-2074
2. Submission Contact Person
LK Consulting Group USA, Inc. 1150 ROOSEVELT, SUITE 200 Irvine , CA 92620 Priscilla Chung Phone: 714 2025789 Ext Email: Juhee.C(@)Lkconsultinggroup.com
3. Subject Device
- -. Trade Name : ELEC Master & ELEC Master Dual
- -. Classification Name : Controller, Foot, Handpiece and Cord
- -. Regulation Number : 21 CFR 872.4200
- -. Regulation Name : Dental handpiece and Accessories
- -. Regulatory Class : I
- -. Product Code : EBW
4. Predicate Device
- -. Trade Name : A-dec NLZ electric motor system
- -. 510(k) Number : K163131
- -. Regulation Number : 21 CFR 872.4200
- -. Regulation Name : Dental handpiece and Accessories
- -. Regulatory Class : I
- -. Product Code : EBW
5. Description:
This product consists of a micro motor controller and display panel. Receiving rated input of AC 24V, this device controls motor speed, and rotation direction through the motor control circuit inside the controller. Motor speed, light and rotation direction functions can be set on the display panel.
| Micromotor Model Name | ELEC Master | ELEC Master Dual |
|---|---|---|
| Optic(White LED) | O | O |
| Torque | Max. 3Ncm | Max. 3Ncm |
| Number of motor(EML40W) | 1 | 2 |
| RPM(Gear 1: 1) | Max. 40,000 | Max. 40,000 |
4
| Direction | Clock / counter clock | Clock / counter clock |
|---|---|---|
| ----------- | ----------------------- | ----------------------- |
6. Indications for Use
ELEC Master & ELEC Master Dual are intended for use in general dental applications such as: cutting a tooth for cavity preparation, crown preparation, crown finishing, inlay, filing, polishing, prophylaxis and endodontic treatment.
7. Substantial Equivalence Discussion:
The subject device is substantially equivalent to A-dec NLZ electric motor system (K163131). The subject device has the same indications for use and the technological characteristics as the predicate device. It also has the equivalent specifications as the predicate device in almost all parameters. The major difference is spray air pressure & spray water pressure. However this differences do not raise a question in substantial equivalence discussion since the user can use water and air spray hoses that are usually provided on a dental chair in the dental office. Since these are optional features, we believe these differences do not raise a new question in safety and effectiveness. Based on the performance test data, we conclude that the subject device is substantially equivalent to the predicate device.
| Candidate Device | Predicate 1 | Comparison | |
|---|---|---|---|
| 510(k) Number | K202963 | K163131 | - |
| Device Name | ELEC Master | ||
| ELEC Master Dual | A-dec NLZ electric motor | ||
| system | - | ||
| Manufacturer | MGNEWTON Ltd. | NAKANISHI INC. | - |
| Indications for Use | ELEC Master & | ||
| ELEC Master Dual | |||
| are intended for use in | |||
| general dental | |||
| applications such as: | |||
| cutting a tooth for | |||
| cavity preparation, | |||
| crown preparation, | |||
| crown finishing, inlay, | |||
| filing, polishing, | |||
| prophylaxis and | |||
| endodontic treatment. | A-dec NLZ electric motor | ||
| system is intended for use | |||
| in general dental | |||
| applications such as: | |||
| cutting a tooth for cavity | |||
| preparation, crown | |||
| preparation, crown | |||
| finishing, inlay, filing, | |||
| polishing, prophylaxis and | |||
| endodontic treatment. | Substantially | ||
| Equivalent | |||
| Drive | Electronic-micromotor | Electronic-micromotor | Substantially |
| Equivalent | |||
| Device components | Control unit with hose | ||
| and electrical motor | Control unit with hose and | ||
| electrical motor | Substantially | ||
| Equivalent | |||
| Light (Motor LED) | Yes | Yes | Substantially |
| Equivalent | |||
| Range of rotation speed | 1,000-40,000 rpm | 1,000- 40,000 rpm | Substantially |
| Equivalent | |||
| Rotation Direction | Forward and Reverse | Forward and Reverse | Substantially |
| Equivalent | |||
| Max. Torque | 3Ncm | 3Ncm | Substantially |
| Equivalent | |||
| Spray Air Pressure | 44 psi (0.3 MPa) | 29psi (0.2 MPa) | Different #1 |
| Spray Water Pressure | 22 psi (0.15 MPa) | 29psi (0.2 MPa) | Different #2 |
| Coolant mechanism | Coolant air | Coolant air | Substantially |
| Equivalent |
5
| Sterilization | Sterilized by user
(Steam Sterilization) | Sterilized by user
(Steam Sterilization) | Substantially
Equivalent |
|---------------------------------------------------------------------------|---------------------------------------------|---------------------------------------------|-----------------------------|
| Conformance with
standards for shanks
(Available Handpiece
Type) | E-type
Comply with
ISO 3964 | E-type
Comply with
ISO 3964 | Substantially
Equivalent |
8. Performance Tests (Non-clinical)
Non-clinical bench tests were performed as followings:
-
ISO 3964:2016 Dental Handpieces Coupling dimensions
-
ISO 7494-1:2011 Dentistry Dental units -Part 1: General requirements and test methods
-
ISO 14457:2017 Dentistry Handpieces and motors
-
IEC 60601-1, IEC 60601-1-2: Electrical safety and EMC
-
IEC80601-2-60:2012 : Particular Requirements For The Basic Safety And Essential Performance Of Dental Equipment
-
IEC 62366 : Application of usability engineering to medical devices
Along with the above tests, sterilization validation, and software validation were also conducted. None of the testing demonstrated any design characteristics that violated the requirements of the standards or resulted in any safety hazard.
9. Conclusions:
Based on the information provided in this premarket notification, MGNEWTON Ltd. concludes that the ELEC Master & ELEC Master Dual are substantially equivalent to the predicate device as described herein in safety and effectiveness.