(592 days)
No
The description details a standard electric motor system with manual controls for speed, direction, and memory settings. There is no mention of adaptive learning, pattern recognition, or any other characteristic typically associated with AI/ML. The performance studies are based on standard electrical and mechanical safety standards, not data-driven performance metrics.
Yes.
The device operates electrically-driven dental handpieces used in general dental applications, indicating its role in dental procedures that can be considered therapeutic (e.g., drilling, polishing).
No
Explanation: The device is described as a dental electric motor intended to convert pneumatic output to electrical energy to drive an electric micro motor and operate electrically-driven dental handpieces. Its function is to power tools used in general dentistry, not to diagnose medical conditions or diseases.
No
The device description explicitly lists hardware components such as a Control Unit, Micromotor, Motor Cable, and AC Adaptor. The performance studies also include testing against hardware standards like IEC 60601-1 and ISO 14457.
Based on the provided information, the Dental Electric Motor NL400-1 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for converting pneumatic output to electrical energy to drive a motor and operate dental handpieces for general dental applications. This is a mechanical/electrical function performed directly on the patient's teeth and surrounding tissues.
- Device Description: The description details the components and their functions, all related to powering and controlling a dental handpiece. There is no mention of analyzing samples from the human body (like blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
- Lack of IVD Characteristics: IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform any such analysis.
- Performance Studies: The performance studies listed focus on safety, electrical compatibility, mechanical standards for handpieces and motors, software documentation, sterilization, and biological evaluation (cytotoxicity and irritation). These are typical evaluations for medical devices used directly on patients, not for IVD devices.
- Predicate and Reference Devices: The predicate and reference devices listed are also electric motor systems for dental handpieces, further supporting that this device falls under the category of general dental equipment, not IVD.
In summary, the Dental Electric Motor NL400-1 is a medical device used in a clinical setting for performing dental procedures, but it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Dental Electric Motor NL400-1 is intended to convert pneumatic output from a dental treatment center to electrical energy to drive an electric micro motor and to operate electrically- driven dental handpieces.it is for use in general dental applications with use of a straight, right-angle, ISO E-type handpiece attachment of equal, gear-reducing, or gear-increasing speed. This system is designed for use by a trained professional in the field of general dentistry.
Product codes
EBW
Device Description
Dental Electric Motor NL400-1 is a system attached to dental treatment center to operate electrically driven low speed handpieces. It consists of the components Control Unit, Micromotor, Motor Cable, and AC Adaptor. The common gear ratio is 1:1, 16:1 and 1:5, the speed range is from 2000 to 40,000 rpm.
The Control Unit provides the operation panel to achieve different operation functions, such as turn on/off the motor, adjust the motor speed, select memory setting, choose the motor work ratio, and the motor rotate direction.
The Motor Cable is connected to the Control Unit and the Micromotor, and contains lead wires to power the motor and tubing to transmit air/water/spray provided and controlled by the dental treatment center.
The Micromotor is built in with a three-phase DC motor and an LED light, and contains air and water outlet, which can drive the electrically-driven handpiece with the set output parameters and transmits the air/water/spray and lights.
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
This system is designed for use by a trained professional in the field of general 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)
Dental Electric Motor has been evaluated the safety and performance by lab bench testing according to the following standards:
- IEC 60601-1, Medical electrical equipment Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005+ A12)
- IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests, 2014
- ISO 14457, Dentistry Handpieces and motors, First edition 2012-09-15
- Moderate level of software documentation and verification per the FDA Guidance Document for Software Contained in Medical Devices
- Sterilization and cleaning validation per ISO 17665-1, and FDA Guidance Document for Reprocessing of Medical Device
- ISO 10993-5:2009 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity.
- ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
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Foshan CICADA Dental Instrument Co, Ltd. % Jet Li Manager Guangzhou KEDA Biological Technology Co., Ltd 6F, No.1 TianTai Road, Science City, LuoGang District Guangzhou, Guangdong 510010 CHINA
Re: K202075
Trade/Device Name: Dental Electric Motor Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EBW Dated: February 12, 2021 Received: February 14, 2021
Dear Jet Li:
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 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
1
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.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) K202075
Device Name Dental Electric Motor
Indications for Use (Describe)
Dental Electric Motor NL400-1 is intended to convert pneumatic output from a dental treatment center to electrical energy to drive an electric micro motor and to operate electrically- driven dental handpieces.it is for use in general dental applications with use of a straight, right-angle, ISO E-type handpiece attachment of equal, gear-reducing, or gear-increasing speed. This system is designed for use by a trained professional in the field of general dentistry.
| 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 K202075
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR 872.6070, and there were no prior submissions for the subject device.
Submitter Information 1.
Sponsor: Foshan CICADA Dental Instrument Co, Ltd Address: B5-2F, Guangdong New Light Source Industrial Base, Nanhai District, Foshan, Guangdong, China Contact Person: Juan Liu Title: Deputy Manager Phone: +86-0757-85775667 E-mail: info@cicadadental.com
Application Correspondent: Jet Li Company: Guangzhou KEDA Biological Technology Co., Ltd E-mail: med-jl@foxmail.com Phone: 86-18588874857 Address: 6F, No.1 TianTai road, Science City, LuoGang District, GuangZhou City, China
Subject Device Information 2.
- � Type of 510(k) submission: Traditional
- � Classification Name: Dental Handpiece and Accessories
- Trade Name: Dental Electric Motor �
- Model: NL400-1 �
- Review Panel: Dental �
- Product Code: EBW �
- Regulation Number: 21 CFR 872.4200 �
- Regulation Class: 1 �
Predicate and Reference DevicesInformation 3.
Predicate Device
- � Sponsor: Nakanishi, Inc.
- Classification Name: Dental Handpiece and Accessories �
- Trade Name: A-dec NLZ Electric Motor System �
- 510(k) number: K163131 �
- Review Panel: Dental �
4
- � Product Code: EBW
- Regulation Number: 21 CFR 872.4200 �
- Regulation Class: 1 �
Reference Device
- � Sponsor: HANDPIECE HEADQUARTERS.
- Classification Name: Dental Handpiece and Accessories �
- Trade Name: Maxima Electric System �
- � 510(k) number: K180845
- Review Panel: Dental �
- � Product Code: EBW
- Regulation Number: 21 CFR 872.4200 �
- Requlation Class: 1 �
Device Description 4.
Dental Electric Motor NL400-1 is a system attached to dental treatment center to operate electrically driven low speed handpieces. It consists of the components Control Unit, Micromotor, Motor Cable, and AC Adaptor. The common gear ratio is 1:1, 16:1 and 1:5, the speed range is from 2000 to 40,000 rpm.
The Control Unit provides the operation panel to achieve different operation functions, such as turn on/off the motor, adjust the motor speed, select memory setting, choose the motor work ratio, and the motor rotate direction.
The Motor Cable is connected to the Control Unit and the Micromotor, and contains lead wires to power the motor and tubing to transmit air/water/spray provided and controlled by the dental treatment center.
The Micromotor is built in with a three-phase DC motor and an LED light, and contains air and water outlet, which can drive the electrically-driven handpiece with the set output parameters and transmits the air/water/spray and lights.
Indications for UseDental Electric Motor NL400-1 is intended to convert pneumatic output from a dental treatment center to electrical energy to drive an electric micro motor and to operate electrically- driven dental handpieces. It is for use in general dental applications with use of a straight, right-angle or contra-angle, ISO E-type handpiece attachment of equal, gear-reducing, or gear-increasing speed. This system is designed for use by a trained professional in the field of general dentistry.
Test Summary 5.
Dental Electric Motor has been evaluated the safety and performance by lab bench testing according to the following standards:
5
- IEC 60601-1, Medical electrical equipment Part 1: General requirements for basic 区 safety and essential performance (IEC 60601-1:2005+ A12)
- 区 IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests, 2014
- ISO 14457, Dentistry Handpieces and motors, First edition 2012-09-15 区
- Moderate level of software documentation and verification per the FDA Guidance ಸ Document for Software Contained in Medical Devices
- Sterilization and cleaning validation per ISO 17665-1, and FDA Guidance 风 Document for Reprocessing of Medical Device
- 区 ISO 10993-5:2009 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity.
- ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for 区 irritation and skin sensitization
Comparison to Predicate De vice 6.
Compare with predicate device, the subject device is very similar in design principle, intended use, indications for use, functions, material and the applicable standards. The differences between subject device and predicate device do not raise any new
| Elements of
| Comparison | Subject Device | Predicate Device | Reference Device | Verdict |
|---|---|---|---|---|
| Manufacturer | Foshan CICADA Dental | |||
| Instrument Co, Ltd | Nakanishi, Inc. | Handpiece Headquarters - | ||
| HPR Inc | -- | |||
| Product Name | Dental Electric Motor | A-dec NLZ Electric Motor | ||
| System | Maxima Electric System | -- | ||
| 510K number | TBD | K163131 | K180845 | -- |
| Classification Name | Dental Handpiece and | |||
| Accessories | Dental Handpiece and | |||
| Accessories | Dental Handpiece and | |||
| Accessories | -- | |||
| Regulation Class | Class I | Class I | Class I | -- |
| Product Code | EBW | EBW | EBW | -- |
| Regulation Number | 21 CFR 872.4200 | 21 CFR 872.4200 | 21 CFR 872.4200 | -- |
| OTC & Rx | Rx | Rx | Rx | -- |
| Indications for Use | ||||
| Elements of | ||||
| Comparison | Subject Device | Predicate Device | Reference Device | Verdict |
| Indications for Use | Dental Electric Motor NL400-1 | |||
| is intended to convert | ||||
| pneumatic output from a | ||||
| dental treatment center to | ||||
| electrical energy to drive an | ||||
| electric micro motor and to | ||||
| operate electrically- driven | ||||
| dental handpieces.it is for use | ||||
| in general dental applications | ||||
| with use of a straight, right- | ||||
| angle or contra-angle, ISO E- | ||||
| type handpiece attachment of | ||||
| equal, gear-reducing, or gear- | ||||
| increasing speed. This system | ||||
| is designed for use by a | ||||
| trained professional in the | ||||
| field of general dentistry | The A-dec NLZ electric motor | |||
| system is comprised of a | ||||
| control unit that drives a direct | ||||
| current (DC) electric | ||||
| micromotor that is activated by | ||||
| means of a foot control. It is | ||||
| intended for use in general | ||||
| dental applications such as: | ||||
| cutting a tooth for cavity | ||||
| preparation, crow n preparation, | ||||
| crow n finishing, inlay, filing, | ||||
| polishing, prophylaxis and | ||||
| endodontic treatment, with use | ||||
| of a straight, right-angle or | ||||
| contra-angle ISO E-type | ||||
| handpiece attachment of equal, | ||||
| gear-reducing, or gear- | ||||
| increasing speed. | The Maxima Electric System | |||
| is intended to convert | ||||
| pneumatic output from a | ||||
| dental treatment center to | ||||
| electrical energy to drive an | ||||
| electric micro motor and to | ||||
| operate electrically- driven | ||||
| dental handpieces. This | ||||
| system is designed for use | ||||
| by a trained professional in | ||||
| the field of general dentistry. | SE | |||
| Note 1 | ||||
| Device Design | ||||
| Drive Type | Electronic-micromotor | Electronic-micromotor | Electric micromotor | SE |
| Output voltage of | ||||
| adapter | DC 24V | DC 24V | 36V | SE |
| Mainly Components | Control unit, Motor, Motor | |||
| cable Adapter | Motor controller, Electric | |||
| micromotor, Motor tubing | Motor controller, Electric | |||
| micromotor, Motor tubing, | ||||
| Adapter | SE | |||
| Note2 | ||||
| Dimensions | Control Unit: | |||
| L130×W120×H48mm | ||||
| Motor cable: 92cm | ||||
| Micromotor: L103×Φ15.7mm, | ||||
| tubing length 1530mm | Motor controller: | |||
| D78.5×W148.0×H43.0mm | ||||
| Motor Length: 31 mm | ||||
| Motor Diameter: Φ20.1(Front) | ||||
| Ф22.1(Rear) | ||||
| Motor tubing length: | ||||
| NLZ CDAS: 1600mm | ||||
| NLZ CDAL: 2080mm | / | SE | ||
| Note2 | ||||
| Coolant mechanism | Coolant air | Coolant air | / | SE |
| Function | Motor start/stop | Motor rotation/stop, speed | Speed control, Torque | SE |
| Elements of | ||||
| Comparison | Subject Device | Predicate Device | Reference Device | Verdict |
| Rotation speed setting | setting value, torque setting | control, Program Memory | Note3 | |
| Rotation direction setting | value, and LED turning | |||
| Rotation ratio setting | ON/OFF, instructed rotation | |||
| Recorded rpm memory | speed and torque, standard | |||
| mode and endo mode | ||||
| Allow of Foot switch | ||||
| to control | YES | YES | YES | SE |
| Internal irrigation | Yes | / | Yes | SE |
| Composition of Materials | ||||
| Motor exterior/Interior | Stainless Steel | Titanium | Stainless Steel | SE |
| Motor Cable/Air and | ||||
| water channel | Silicone rubber/PU Rubber | - | Silicone rubber | SE |
| Comply | ||||
| with ISO | ||||
| 10993-1 | ||||
| Light | LED | LED | LED | SE |
| Technical Specifications | ||||
| Range of rotation | ||||
| speed | 2000-40000rpm | standard mode: 1,000-40,000 | ||
| rpm | ||||
| endo mode: 100-5,000 rpm | 100-40,000rpm | SE | ||
| Note 3 | ||||
| Speed Ratio | 16:1, 1:1, 1:5 | / | 1:5, 1:1 | SE |
| Note3 | ||||
| Rotating direction | Forward and Reverse | Forward and Reverse | / | SE |
| Maximum Torque | 4.20 N*cm(Stall torque) | 4.00 N*cm(Stall torque) | / | SE |
| Note4 | ||||
| Torque Range | 1-3.0 N*cm | 0.30-3.00 N*cm | 3.0 N*cm | SE |
| Note4 | ||||
| Sterilization | Sterilized by user (steam | |||
| sterilization) | Sterilized by user (steam | |||
| sterilization) | Sterilized by user (steam | |||
| sterilization) | SE | |||
| Available Handpiece | ||||
| type | E-type (ISO3964) | E-type (ISO3964) | E-type (ISO3964) | SE |
| FDA-Recognized Standards | ||||
| Electrical safety, | ||||
| EMC | IEC 60601-1 | |||
| IEC 60601-1-2 | ||||
| ISO 14457 | IEC 60601-1 | |||
| IEC 60601-1-2 | ||||
| ISO 14457 | IEC 60601-1 | |||
| IEC 60601-1-2 | ||||
| ISO 14457 | SE |
questions of safety or effectiveness.
6
Foshan CICADA Dental Instrument Co, Ltd Sponsor:
Dental Electric Motor, Model: NL400-1 Subject Device:
7
Foshan CICADA Dental Instrument Co, Ltd Sponsor:
Dental Electric Motor, Model: NL400-1 Subject Device:
8
Note 1
Although there is little difference for illustration about the indication for use, the description of the predicate device is more specified, yet their meanings are the same. This difference does not affect the safety and effectiveness.
Note 2
Although the subject device has a motor build-in a connecting tube, and the control unit of predicate device is contained within external delivery system, the design and functions of subject device are mainly equivalent to the predicate device and reference device. The differences do not affect the safety and effectiveness.
Note 3
Although the Speed and gear ratio of subject device are little different to the predicate devices, the subject device is compiled with ISO 14457. And the subject device provides 16:1 gear ratio to transfer the handpiece speed to lowest speed of 100 rpm. So the minor differences do not affect the safety and effectiveness
Note 4
Although the subject device has not provided torque control, the stall torque of electric mircomotor is similar to the predicate device, the differences do not affect the safety and effectiveness.
7. Summary for clinical test
Clinical performance is not deemed necessary.
8. Conclusion
The subject device Dental Electric Motor has all features of the predicate device and reference device for intended use. Thus, the subject device is substantially equivalent to the predicate device.
9. Summary Prepared Date
Mar 3, 2022