Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or any related technologies in the device description, intended use, or performance studies. The device appears to be a standard motorized handpiece with root canal measurement capabilities.

Therapeutic

Yes
The device is used for "preparation and enlargement of root canals" and "enlarge the canals while monitoring the file tip inside the canal," which are therapeutic interventions.

Diagnostic

Yes

The device is described as having "root canal measurement capability" and can be used for "measuring the canal length" and "monitoring the file tip inside the canal," which are diagnostic functions.

SaMD (Software as a Medical Device)

No

The device description explicitly states it includes a "cordless hand-piece with charging adapter" and a "chuck for holding rotary instruments," indicating it is a physical device with hardware components, not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is for "preparation and enlargement of root canals, or measuring the canal length." This is a surgical/procedural use, not a diagnostic test performed on samples taken from the body.
Device Description: The description focuses on the mechanical function of the device (holding files, rotating, adjusting speed and torque) for physically altering the root canal.
Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition. The "measuring the canal length" is a physical measurement within the body, not a diagnostic test.
Performance Studies: The performance studies listed are related to the device's safety, electrical performance, software validation, usability, sterilization, and mechanical performance in a dental context. There are no studies related to diagnostic accuracy (sensitivity, specificity, etc.).

In summary, the device is a tool used for a dental procedure (endodontic treatment), not a device used to perform diagnostic tests on samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Endo Motor, Ai-Motor and Endo Radar Plus are cordless endodontic treatment motorized handpiece with root canal measurement capability. It can be used for preparation and enlargement of root canals, or measuring the canal length. And it can be used to enlarge the canals while monitoring the file tip inside the canal.

Product codes (comma separated list FDA assigned to the subject device)

EKX

Device Description

The Endo Motor Series includes a cordless hand-piece with charging adapter. The device has a chuck for holding rotary instruments such as dental files, and is mainly used in Endodontic surgeries. The device can enlarge the root canal by filing the dentin and measuring the root canal length, and may also be used for cutting and grinding for the preparation of root canal surgery. The rotary speed and the torque range can also be adjusted.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Root canal Softened dentin

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Dental Clinic University Hospital The other clinical settings

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 Testing: Woodpecker completed the following non-clinical tests to demonstrate substantial equivalence in safety and effectiveness of Endo Motor Series to the predicate device. Results confirm that the design inputs and performance specifications for the device are met. The Endo Motor Series passed the testing in accordance with internal requirements, and international standards shown below, supporting its safety and its substantial equivalence to the predicate device:

Cytotoxicity testing per ISO 10993-5 Passed
Sensitization testing per ISO 10993-10 Passed
Electrical safety testing per IEC 60601-1 Passed
Electromagnetic Disturbance (EMD) testing per IEC 60601-1-2 Passed
Software verification and validation per IEC 62304/FDA Guidance - Met Requirements
Usability per IEC 62366-1 - Met specifications
Shipping Containers and Systems Performance, per ASTM D4169 Demonstrates package integrity maintained
Dental Performance Requirements, per IEC 80601-2-60 Passed
Processing of Medical Device, per ISO 17664 - Passed
Development, Validation and Routine Control of Sterilization Process, per ISO 17665-1 Passed
Moist Heat Sterilization, per ISO TS 17665-2 - Passed
Dentistry - Handpieces and Motors, per ISO 14457 - Passed
Performance Comparison Testing of Root Canal Measurement Passed

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.

K170275

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.

K161213

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

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.

Summary

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Image /page/0/Picture/0 description: The image shows 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 is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".

May 10, 2021

Guilin Woodpecker Medical Instrument Co., Ltd. % Giselle Zhang Regulatory Consultant Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, Texas 78746

Re: K203320

Trade/Device Name: Endo Motor Regulation Number: 21 CFR 872.4200 Regulation Name: Dental handpiece and accessories Regulatory Class: Class I, reserved Product Code: EKX Dated: April 13, 2021 Received: May 10, 2021

Dear Giselle Zhang:

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

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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 (OS) 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,

For Michael Adjodha 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

Enclosure

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Indications for Use

510(k) Number (if known) K203320

Device Name

Endo Motor

Indications for Use (Describe)

Endo Motor, Ai-Motor and Endo Radar Plus are cordless endodontic treatment motorized handpiece with root canal measurement capability. It can be used for preparation and enlargement of root canals, or measuring the canal length. And it can be used to enlarge the canals while monitoring the file tip inside the canal.

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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5. 510(k) Summary

The following information is provided in accordance with 21 CFR 807.92 for the Premarket 510(k) Summary:

5.1 Submitter Information

Company:	Alex Wang
	Registration & Certification
	GUILIN WOODPECKER MEDICAL
	INSTRUMENT CO., LTD
	Information Industrial Park, Guilin National High
	Tech Zone
	Guilin, Guangxi 541004 P.R. China
	Telephone: 0086-773-2350532
	Fax: 0086-773-5822450
	zmnbg03@glwoodpecker.com
Contact:	Giselle Zhang
	Regulatory Consultant
	Emergo Global Consulting, LLC
	2500 Bee Cave Road, Building 1, Suite 300
	Austin, Texas 78746 USA
	Telephone: (512) 327-9997
	Fax: (512) 327-9998
	LST.AUS.ProjectManagement@ul.com
Date Summary Prepared:	March 29, 2021

5.2 Device Name and Regulatory Information

Trade Name:	Endo Motor
Common Name:	Dental handpiece and accessories
Classification Name:	Dental
Review Panel:	Dental (DE)
Regulation:	872.4200
Class:	Class I
Product Code:	EKX

5.3 Equivalence Claimed to PredicateDevice

The Endo Motor is equivalent to the Tri Auto ZX2 (K170275), manufactured by J. MORITA USA, INC.. XSmart iQ (K161213) is provided as a reference device.

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5.4 Device Description

The Endo Motor Series includes a cordless hand-piece with charging adapter. The device has a chuck for holding rotary instruments such as dental files, and is mainly used in Endodontic surgeries. The device can enlarge the root canal by filing the dentin and measuring the root canal length, and may also be used for cutting and grinding for the preparation of root canal surgery. The rotary speed and the torque range can also be adjusted.

5.5 Intended Use Statement

Endo Motor, Ai-Motor and Endo Radar Plus are cordless endodontic treatment motorized handpiece with root canal measurement capability. It can be used for preparation and enlargement of root canals, or measuring the canal length. And it can be used to enlarge the canals while monitoring the position of the tip inside the canal.

5.6 Non-Clinical Testing

To demonstrate substantial equivalence in safety and effectiveness of Endo Motor Series to the predicate device, Woodpecker completed the following non-clinical tests. Results confirm that the design inputs and performance specifications for the device are met. The Endo Motor Series passed the testing in accordance with internal requirements, and international standards shown below, supporting its safety and its substantial equivalence to the predicate device :

Cytotoxicity testing per ISO 10993-5 Passed .
Sensitization testing per ISO 10993-10 Passed ●
Electrical safety testing per IEC 60601-1 Passed ●
Electromagnetic Disturbance (EMD) testing per IEC 60601-1-2 Passed ●
Software verification and validation per IEC 62304/FDA Guidance - Met Requirements
. Usability per IEC 62366-1 - Met specifications
Shipping Containers and Systems Performance, per ASTM D4169 Demonstrates package integrity ● maintained
Dental Performance Requirements, per IEC 80601-2-60 Passed Processing of Medical Device, per ISO ● 17664 - Passed
Development, Validation and Routine Control of Sterilization Process, per ISO 17665-1 Passed Moist . Heat Sterilization, per ISO TS 17665-2 - Passed
Dentistry - Handpieces and Motors, per ISO 14457 - Passed
Performance Comparison Testing of Root Canal Measurement Passed ●

5.7 Substantial Equivalence Discussion

Both Tri Auto ZX2 and Endo Motor Series are battery-driven handpieces with a motor, equipped with a chuck for holding rotary instruments such as a dental file. Both devices can be used for cutting and grinding teeth by transferring rotary movement to a rotary instrument attached to the head. Cutting and grinding of teeth can be done depending on switching/reversing the rotation direction. Rotation speed is acceleratedaccording to the user's preference, rotation control is based on torque detection, or pre-set time. These controls enable the cutting, grinding, enlargement, and preparation of root canals. Both devices can be used as an apex locator, and the measured value can be used for rotation control. Also both devices are intended to be sterilized prior touse.

The Tri Auto ZX2 can be used for the removal of extraneous materials such as gutta-percha points, and for professional mechanical tooth cleaning.

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The XSmart iQ is used as a reference device. As for the XSmart iQ, the Endo Motor series includes cordless motor hand-pieces, and both devices have a console. The Endo Radar Plus has integrated the display on the base but XSmart iQ is based on an Apple iPad Mini®. The motor parameters can be transferred, stored and displayed via the base on the Endo Radar Plus, but XSmart iQ uses iPad Mini® application (Endo iQ app).

Table 5.1: Substantial Equivalence Discussion
Attribute	Endo Motor, Ai- Motor	Endo Motor, Endo Radar Plus	Tri-Auto ZX2 K170275 (Primary)
Manufacturer	GUILIN WOODPECKER
MEDICAL INSTRUMENT
CO., LTD	GUILIN WOODPECKER
MEDICAL INSTRUMENT
CO., LTD	J. MORITA USA, INC.
Intended Use	Canal Enlargement Root
Canal Length Measurement	Canal Enlargement Root
Canal Length Measurement	Canal Enlargement Root
Canal Length Measurement
Indication for Use	Endo Motor, Ai- Motor is a
cordless endo motor with
root canal measurement
capability. It can be used as
a endo motor for
preparation and
enlargement of root canals,
or device for measuring
canal length. It can be used
to enlarge the canals while
monitoring the position of
the file tip inside the canal.	Endo Motor, Ai- Motor and
Endo Radar Plus are
cordless endodontic motor
with root canal
measurement capability. It
can be used as a endo motor
for preparation and
enlargement of root canals,
or device for measuring
canal length. It can be used
to enlarge the canals while
monitoring the position of
the file tip inside the canal.	The Tri Auto ZX2 device is
a cordless endodontic
treatment motorized
handpiece with root canal
measurement capability. It
can be used to enlarge
canals while monitoring the
position of the file tip
inside the canal. It can be
used as a low-speed
motorized handpiece and
device for measuring canal
length.
Target Population	Patients in need of root
canal surgery	Patients in need of root
canal surgery	Patients in need of root
canal surgery
Anatomical Sites	Root canal Softened dentin	Root canal Softened dentin	Root canal Softened dentin
Where Used	Dental Clinic
University
Hospital
The other clinical settings	Dental Clinic
University
Hospital
The other clinical settings	Dental Clinic
University
Hospital
The other clinical settings
Dimension	Motor Handpiece: 28 mm x
33.7 mm
x 199.2 mm	Motor Handpiece:
27.8 mm x 29 mm
x 212 mm	Motor Handpiece: 30 mm x
30 mm x
200 mm
Weight	150g	151g	140g
User Interface	Four push buttons:
ON/OFF
Setting button
Adjusting button "+"
Adjusting button "-"	Push Button of Handpiece:
ON/OFF
Touch Button of Base:
"Power" button: Control
the power on or off.
"Auto Rev" button
"REV" button
"En-Ap" button
"SET" button
"SYSTEM" adjusting
button
"FILE" button
"TORQUE" button
"SPEED" button
"ANGLE" button	Four push buttons:
ON/OFF
Setting button
Adjusting button “+”
Adjusting button "-"
Materials of Motor
Handpiece	PC/PBT blend (PC-
Polycarbonate, PBT-
polybutylene terephthalate)	PC/PBT blend (PC-
Polycarbonate, PBT-
polybutylene terephthalate)	PC/PBT blend (PC-
Polycarbonate, PBT-
polybutylene terephthalate)
	lithium battery (3.7V)	3.7 V)
Charger Power Supply	AC100V-240V	AC100V-240V	AC100V-240V
Frequency of Supply
Voltage	50Hz ~ 60Hz	50Hz ~ 60Hz	50Hz ~ 60Hz
Components	Measuring wire
File clip Lip hook
Touch probe
Silicon Cover
Tester
Spray Nozzle	Measuring wire
File clip Lip hook
Touch probe
Silicon Cover
Tester
Spray Nozzle	Tester
Spray Nozzle
Safety Mechanism	Automatically stops or
reversely rotates as soon as
the file reaches the apical
stop, so as to prevent
perforation.	Automatically stops or
reversely rotates as soon as
thefile reaches the apical
stop, so as to prevent
perforation.	Auto Torque Reverse:
The OTR (Optimum
Torque Reverse) function
enables the file to reverse
its rotational direction upon
reaching a certain torque.
After rotating in reverse by
90 degrees, the file returns
to the cutting direction.
Battery Indicator	When the blue indicator on
the charging base flashes, it
is charging.
When the motor handpiece
is fully charged, the blue
indicator on the charging
base would be always on.	Motor hand-piece battery
level is displayed on base.

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5.8 Conclusion

The Endo Motor Series has the same intended use and the same or similar technological characteristics and functionality as the predicate, and therefore is substantially equivalent to the predicate device. The differences are minor and supported by the reference device to demonstrate they do not raise new questions of safety and effectiveness as compared to the predicate device.