(644 days)
Not Found
No
The description focuses on basic electronic control of a motor based on user input and pre-defined modes, with no mention of learning, adaptation, or complex data processing characteristic of AI/ML.
No.
The device controls dental handpieces used in restoration, prophylaxis, and endodontic procedures, but it does not directly treat or diagnose a disease or condition. It is an accessory device that provides control for other instruments which perform the therapeutic actions.
No
The device is described as a motor controller for dental handpieces used in restoration, prophylaxis, and endodontic procedures, which are treatment-oriented rather than diagnostic.
No
The device description explicitly states it consists of a "micro motor controller and display panel" and receives "AC 24V" input, indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as being for "restoration, prophylaxis and endodontic procedures" in dentistry. These are clinical procedures performed directly on a patient.
- Device Description: The device controls motorized dental handpieces, which are tools used in these clinical procedures.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests or analyze biological samples.
The device is a piece of equipment used in a clinical setting for direct patient treatment, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The ELEC-LED is intended for use in dentistry for restoration, prophylaxis and endodontic procedures. It provides control for motorized dental handpieces by converting pneumatic output from a dental treatment center.
Product codes
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 spinning direction through the motor control circuit inside the controller. Motor speed, motor operating mode, light and spinning direction functions can be set on the display panel. The operating mode of the motor is composed of three modes: HD (Hand control mode), PP (Press pedal mode) and EP (Electric pedal mode).
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
dentistry
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 62366-1, 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
- ANSI AAMI ST79:2017, ISO 17665-1, and ISO TS 17665-2: Sterilization validation
Software documentation for software of moderate level of concern per the FDA Guidance Document for Software Contained in Medical Devices was provided . The test results support that the subject device is substantially equivalent to the predicate device.
Cleaning and Sterilization validation for the motor cable was provided per the FDA Guidance Document for Reprocessing of Medical Device.
Biocompatibility testing (cytotoxicity, sensitization, and oral mucosa irritation) for the direct and indirect patient contacting components was provided per the FDA Guidance Document for the Use of ISO 10993-1.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 7, 2022
MICRO-NX Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 1150 Roosevelt STE 200 Irvine, California 92620
Re: K201191
Trade/Device Name: ELEC-LED Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EBW Dated: November 9, 2021 Received: November 12, 2021
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 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, M.Ch.E. 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K201191
Device Name ELEC-LED
Indications for Use (Describe)
The ELEC-LED is intended for use in dentistry for restoration, prophylaxis and endodontic procedures. It provides control for motorized dental handpieces by converting pneumatic output from a dental treatment center.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
510(k) Summary
(K201191)
This summary of 510(k) is being submitted in accordance with requirements of 21 CFR Part 807.92
Date: February 3, 2022
1. 510K Applicant / Submitter:
MICRO-NX Co., Ltd. 22, Maeyeo-ro 1gil, Dong-gu, 41059 Republic of Korea Tel: +82-53-650-1000 Fax: +82-53-650-1001
2. Submission Contact Person
Priscilla Chung LK Consulting Group USA, Inc. 1150 Roosevelt STE 200 Irvine CA 92620 Tel: 714.202.5789 Fax: 714.409.3357 Email: juhee.c@LKconsultingGroup.com
2. Subject Device
- Proprietary Name -ELEC-LED
- Common Name Motor Handpiece Control Unit .
- . Classification Name -Dental Handpiece and Accessories
- Product Code - EBW
- Classification Regulation 21 CFR 872.4200
3. Predicate Device
- Optima MX INT by Bien air Dental SA (K042759)
4. Description:
This product consists of a micro motor controller and display panel. Receiving rated input of AC 24V, this device controls motor speed, and spinning direction through the motor control circuit inside the controller. Motor speed, motor operating mode, light and spinning direction functions can be set on the display panel. The operating mode of the motor is composed of three modes: HD (Hand control mode), PP (Press pedal mode) and EP (Electric
4
pedal mode).
5. Indications for Use
The ELEC-LED is intended for use in dentistry for restoration, prophylaxis and endodontic procedures. It provides control for motorized dental handpieces by converting pneumatic output from a dental treatment center.
Substantial Equivalence Discussion: 6.
The subject device is substantially equivalent to Optima MX INT SI0915/923(K042759). 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 that the subject device offers a model without water and air spray hoses, and also a model without LED. However, these 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, and lighting system in the dental office. Since these are optional features, we believe these differences do not raise a concern for substantial equivalence. Based on the comparison and the performance test data, we conclude that the subject device is substantially equivalent to the predicate device.
| Subject Device | Predicate Device | Comparison | |
|---|---|---|---|
| 510(k) Number | K201191 | K042759 | - |
| Device Name | ELEC-LED (EL- | ||
| B40S, EL-B40L, | |||
| EL-B40M, EL- | |||
| B40I) | Optima MX INT | - | |
| Manufacturer | MICRO-NX Co., | ||
| Ltd. | Bien air Dental SA | ||
| Intended Use | The ELEC-LED is | ||
| intended for use in | |||
| dentistry for | |||
| restoration, | |||
| prophylaxis and | |||
| endodontic | |||
| procedures. It | |||
| provides control for | |||
| motorized dental | |||
| handpieces by | |||
| converting | |||
| pneumatic output | |||
| form a dental | |||
| treatment center. | The Optima MX is | ||
| intended for use in | |||
| dentistry for | |||
| restoration, | |||
| prophylaxis and | |||
| endodontic | |||
| procedures. It | |||
| provides control for | |||
| motorized dental | |||
| handpieces by | |||
| converting pneumatic | |||
| output form a dental | |||
| treatment center. | Equivalent |
5
| Micromotor type | Brushless, internal
coolant air | Brushless, internal
coolant air | Identical |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device components | Control unit with
hose and electrical
motor | Control unit with
hose and electrical
motor | Identical |
| Power supply voltage | AC 24V | AC 24V | Identical |
| Speed on the motor | 1,000-40,000 rpm | 100- 40,000 rpm | Equivalent |
| Max. Torque | 3Ncm | 3Ncm | Identical |
| Rotation direction | clockwise /
counterclockwise | clockwise /
counterclockwise | Identical |
| Spray Air Pressure | 2.5bar | 2.5bar | Identical |
| Spray Water Pressure | 2bar | 2bar | Identical |
| Irrigation system | 1) EL-B40S, EL-B40S, EL-B40I(Irrigation system, motor cooling air)
-
EL-B40M (only motor cooling air) | Irrigation and motor
Cooling air | The EL-B40M type
does not have water
injection function,
therefore, there is
no water and air
spray hoses.
The user can use
water and air spray
hoses that are
usually provided on
a dental chair. |
| Light(Motor LED) | 1) Yes (EL-B40S, EL-B40L) -
No (EL-B40I, EL-B40M) | Yes | The subject device
has both a model
with an LED and a
model without
LED; however,
since this product is
used in a dental
office which will be
likely to have
lighting system, it
does not pose any
risk. |
| Conformance with
standards for shanks | Comply with
ISO 3964 | Comply with
ISO 3964 | Identical |
| Rotation | Clockwise,
Counterclockwise | Clockwise,
Counterclockwise | Identical |
6
7. 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 62366-1, 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
-
ANSI AAMI ST79:2017, ISO 17665-1, and ISO TS 17665-2: Sterilization validation
Software documentation for software of moderate level of concern per the FDA Guidance Document for Software Contained in Medical Devices was provided . The test results support that the subject device is substantially equivalent to the predicate device.
Cleaning and Sterilization validation for the motor cable was provided per the FDA Guidance Document for Reprocessing of Medical Device.
Biocompatibility testing (cytotoxicity, sensitization, and oral mucosa irritation) for the direct and indirect patient contacting components was provided per the FDA Guidance Document for the Use of ISO 10993-1.
8. Conclusions:
Based on the information provided in this premarket notification, MICRO-NX Co., Ltd. concludes that the ELEC-LED is substantially equivalent to the predicate device as described herein in.