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.

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.

AI/ML Overview

The provided text is a 510(k) summary for a "Dental Electric Motor." This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for an AI/ML powered medical device. Therefore, the information required to answer your questions regarding acceptance criteria and supporting studies for an AI device is largely not present in this document.

Here's an attempt to answer based on the provided text, highlighting what is missing or not applicable:

1. A table of acceptance criteria and the reported device performance

This document does not define specific performance acceptance criteria or report performance in the typical sense for an AI/ML device (e.g., sensitivity, specificity, AUC). Instead, it conducts a comparison to predicate devices, where "performance" is implicitly evaluated by demonstrating that the subject device meets relevant safety and performance standards (like IEC 60601-1, IEC 60601-1-2, ISO 14457).

The closest to "acceptance criteria" for this conventional device are the general safety and performance standards it was tested against. The "reported device performance" would be that it complies with these standards.

Acceptance Criteria (Implied from testing standards)	Reported Device Performance (Implied from Summary)
Compliance with IEC 60601-1 (Medical electrical equipment basic safety and essential performance)	Device has been evaluated for safety and performance by lab bench testing according to IEC 60601-1.
Compliance with IEC 60601-1-2 (Electromagnetic compatibility)	Device has been evaluated for safety and performance by lab bench testing according to IEC 60601-1-2.
Compliance with ISO 14457 (Dentistry Handpieces and motors)	Device has been evaluated for safety and performance by lab bench testing according to ISO 14457. Additionally, specific features like speed and gear ratio are stated to comply with ISO 14457.
Moderate level of software documentation and verification	Performed (stated as "Moderate level of software documentation and verification per the FDA Guidance Document for Software Contained in Medical Devices").
Sterilization and cleaning validation	Performed per ISO 17665-1 and FDA Guidance Document for Reprocessing of Medical Device.
Biological evaluation (in vitro cytotoxicity)	Performed per ISO 10993-5:2009.
Biological evaluation (irritation and skin sensitization)	Performed per ISO 10993-10:2010.
Substantial Equivalence to Predicate Device (in terms of design, intended use, indications for use, functions, material and applicable standards)	Concluded as substantially equivalent, with minor differences not affecting safety and effectiveness.
Speed Range (2000-40000rpm)	Achieved 2000-40000rpm (Subject Device, Technical Specifications).
Speed Ratio (16:1, 1:1, 1:5)	Achieved 16:1, 1:1, 1:5 (Subject Device, Technical Specifications).
Maximum Torque (4.20 N*cm)	Achieved 4.20 N*cm (Subject Device, Technical Specifications).
Torque Range (1-3.0 N*cm)	Achieved 1-3.0 N*cm (Subject Device, Technical Specifications).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided because the submission describes testing of a physical device against standards, not an AI/ML model for which "test sets" of data are typically defined in this manner. The testing described is lab bench testing of the physical hardware.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as there is no AI/ML model and thus no "ground truth" establishment in the context of expert review of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for a physical device substantial equivalence submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a dental electric motor, a piece of hardware, not an AI-assisted diagnostic or treatment planning tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. There is no algorithm or AI component in the device description.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. For a physical device, compliance with standards and functional specifications constitutes the "truth" or verification of its performance.

8. The sample size for the training set

Not applicable. This document pertains to a physical dental electric motor, not an AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established

Not applicable. There is no AI/ML algorithm or training set discussed.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K202075

Device Name Dental Electric Motor

Indications for Use (Describe)

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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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 �

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� 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.

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:

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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 ofComparison	Subject Device	Predicate Device	Reference Device	Verdict
Manufacturer	Foshan CICADA DentalInstrument Co, Ltd	Nakanishi, Inc.	Handpiece Headquarters -HPR Inc	--
Product Name	Dental Electric Motor	A-dec NLZ Electric MotorSystem	Maxima Electric System	--
510K number	TBD	K163131	K180845	--
Classification Name	Dental Handpiece andAccessories	Dental Handpiece andAccessories	Dental Handpiece andAccessories	--
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 ofComparison	Subject Device	Predicate Device	Reference Device	Verdict
Indications for Use	Dental Electric Motor NL400-1is intended to convertpneumatic output from adental treatment center toelectrical energy to drive anelectric micro motor and tooperate electrically- drivendental handpieces.it is for usein general dental applicationswith use of a straight, right-angle or contra-angle, ISO E-type handpiece attachment ofequal, gear-reducing, or gear-increasing speed. This systemis designed for use by atrained professional in thefield of general dentistry	The A-dec NLZ electric motorsystem is comprised of acontrol unit that drives a directcurrent (DC) electricmicromotor that is activated bymeans of a foot control. It isintended for use in generaldental applications such as:cutting a tooth for cavitypreparation, crow n preparation,crow n finishing, inlay, filing,polishing, prophylaxis andendodontic treatment, with useof a straight, right-angle orcontra-angle ISO E-typehandpiece attachment of equal,gear-reducing, or gear-increasing speed.	The Maxima Electric Systemis intended to convertpneumatic output from adental treatment center toelectrical energy to drive anelectric micro motor and tooperate electrically- drivendental handpieces. Thissystem is designed for useby a trained professional inthe field of general dentistry.	SENote 1
Device Design
Drive Type	Electronic-micromotor	Electronic-micromotor	Electric micromotor	SE
Output voltage ofadapter	DC 24V	DC 24V	36V	SE
Mainly Components	Control unit, Motor, Motorcable Adapter	Motor controller, Electricmicromotor, Motor tubing	Motor controller, Electricmicromotor, Motor tubing,Adapter	SENote2
Dimensions	Control Unit:L130×W120×H48mmMotor cable: 92cmMicromotor: L103×Φ15.7mm,tubing length 1530mm	Motor controller:D78.5×W148.0×H43.0mmMotor Length: 31 mmMotor Diameter: Φ20.1(Front)Ф22.1(Rear)Motor tubing length:NLZ CDAS: 1600mmNLZ CDAL: 2080mm	/	SENote2
Coolant mechanism	Coolant air	Coolant air	/	SE
Function	Motor start/stop	Motor rotation/stop, speed	Speed control, Torque	SE
Elements ofComparison	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, standardmode and endo mode
Allow of Foot switchto 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 andwater channel	Silicone rubber/PU Rubber	-	Silicone rubber	SEComplywith ISO10993-1
Light	LED	LED	LED	SE
Technical Specifications
Range of rotationspeed	2000-40000rpm	standard mode: 1,000-40,000rpmendo mode: 100-5,000 rpm	100-40,000rpm	SENote 3
Speed Ratio	16:1, 1:1, 1:5	/	1:5, 1:1	SENote3
Rotating direction	Forward and Reverse	Forward and Reverse	/	SE
Maximum Torque	4.20 N*cm(Stall torque)	4.00 N*cm(Stall torque)	/	SENote4
Torque Range	1-3.0 N*cm	0.30-3.00 N*cm	3.0 N*cm	SENote4
Sterilization	Sterilized by user (steamsterilization)	Sterilized by user (steamsterilization)	Sterilized by user (steamsterilization)	SE
Available Handpiecetype	E-type (ISO3964)	E-type (ISO3964)	E-type (ISO3964)	SE
FDA-Recognized Standards
Electrical safety,EMC	IEC 60601-1IEC 60601-1-2ISO 14457	IEC 60601-1IEC 60601-1-2ISO 14457	IEC 60601-1IEC 60601-1-2ISO 14457	SE

questions of safety or effectiveness.

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Foshan CICADA Dental Instrument Co, Ltd Sponsor:

Dental Electric Motor, Model: NL400-1 Subject Device:

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Foshan CICADA Dental Instrument Co, Ltd Sponsor:

Dental Electric Motor, Model: NL400-1 Subject Device:

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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

Regulation Number and Section

§ 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.