K Number

Device Name

Pro M Class

Manufacturer

Saeyang Microtech Co., Ltd.

Date Cleared

2022-09-19

(279 days)

Product Code

EKX

Regulation Number

872.4200

Intended Use

The PRO M CLASS is used by dental professionals for orthodontic procedures using a root canal instrument and tightening and loosening an abutment screw to fix and remove the abutment on a dental implant in prosthodontic treatment.

Device Description

The PRO M CLASS is an AC-powered device that includes a 'Motor Handpiece', 'Contra angle Handpiece', 'Charger unit' and 'AC/DC Adaptor' for grinding, cutting, polishing and screw driver work in dental oral use. The PRO M CLASS uses the battery inside the motor handpiece as a power source to rotate the micromotor to transmit the generated rotational power to the contra angle. Dental treatment is performed using the rotational power obtained by this. The motor turned by the power converted into DC 5.0V by controller delivers its turning power to the file through spin to perform punching, cutting and removing functions. The hand-piece can be operated, stopped and set/adjusted on/in its speed, torque and turning direction by handling of the controller.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K111616

Reference Devices

K161500, K110278

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on mechanical and electrical components for dental procedures, with no mention of AI/ML terms or functionalities.

Therapeutic

No.
The device is used for mechanical procedures like grinding, cutting, polishing, and tightening/loosening screws, not for treating or diagnosing a disease or condition.

Diagnostic

No
The device description states it is used for "grinding, cutting, polishing and screw driver work" and "punching, cutting and removing functions" in dental oral use, which are all therapeutic or procedural actions, not diagnostic ones.

SaMD (Software as a Medical Device)

The device description explicitly lists multiple hardware components (Motor Handpiece, Contra angle Handpiece, Charger unit, AC/DC Adaptor) and describes their physical functions and power source.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly states that the device is used by dental professionals for procedures within the mouth (orthodontic and prosthodontic treatments). IVD devices are used to examine specimens outside the body (in vitro) to provide information about a patient's health.
Device Description: The description details a device that performs mechanical actions (grinding, cutting, polishing, screw driver work) directly on teeth and dental implants. This is a therapeutic or procedural device, not a diagnostic one.
Anatomical Site: The anatomical site is "dental oral use," which is within the body.
Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory tests.

The PRO M CLASS is a dental handpiece system used for performing dental procedures, which falls under the category of medical devices, but not specifically In Vitro Diagnostic devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

EKX

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Dental oral use / dental implant

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Dental professionals

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)

Electrical safety and performance testing was performed, complying with IEC 60601-1, IEC 80601-2-60, and IEC 62133-2. The testing results indicated that differences in external design, technological characteristics, and battery voltage compared to the predicate device do not raise new safety or effectiveness issues.

Sterilization validation was performed per ISO 17665-1. The differences in sterilization methods compared to the predicate device do not raise new safety or effectiveness issues.

A performance test (Bench test) was conducted according to ISO 14457. The testing results showed that differences in motor rotation speed do not raise any problems in safety and effectiveness.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K111616

Reference Device(s)

K161500, K110278

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

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.

September 19, 2022

Saeyang Microtech Co., Ltd. % DongHa Lee RA Consultant KMC, Inc Room no. 1709, 123, Digital-ro 26-gil, Guro-gu, Seoul 08390 SOUTH KOREA

Re: K213897

Trade/Device Name: Pro M Class Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EKX Dated: June 16, 2022 Received: June 21, 2022

Dear Yeon Woo:

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 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,

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

Indications for Use

510(k) Number (if known) K213897

Device Name

PRO M CLASS

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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V. 510(k) Summary (K213897)

This summary of 510(K) - substantial equivalence information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: June 16, 2022

1. Applicant / Submitter

Saeyang Microtech Co., Ltd. 348, Seongseo-ro, Dalseo-gu, Daegu, Republic of Korea, Tel: +82-53-582-9000~2

2. Submission Correspondent

DongHa Lee (Consultant, KMC, Inc.) Address: Room no. 1709, 123, Digital-ro 26-gil, Guro-gu, Seoul, 08390, South Korea Tel: +82-70-8965-5554 Fax: +82-2-856-5904 Email: dhlee@kmcerti.com

3. Device

■ Trade Name:	PRO M CLASS
■ Common Name:	AC-Powered Direct Drive Handpiece
■ Classification Name:	Dental handpiece and accessories
■ Classification Product Code:	EKX
■ Classification Regulation:	21 CFR 872.4200
■ Device Class:	Class I

4. Predicate Device

Predicate Devices: (K111616) E-CUBE

■ Reference Devices: (K161500) MEG-TORQ (K110278) Cordless Prosthodontic Screwdriver with Torque Calibration System, Model iSD900

5. Description

■ General

[Note] The Dental Bur is not provided with the subject device.

■ Technological Characteristics

The PRO M CLASS uses the battery inside the motor handpiece as a power source to rotate the micromotor to transmit the generated rotational power to the contra angle. Dental treatment is performed using the rotational power obtained by this.

. Principle of Operation

The motor turned by the power converted into DC 5.0V by controller delivers its turning power to the file through spin to perform punching, cutting and removing functions. The hand-piece can be operated, stopped and set/adjusted on/in its speed, torque and turning direction by handling of the controller.

6. Indication for use

7. Basis for Substantial Equivalence

The PRO M CLASS is substantially equivalent to the predicate device in terms of intended use, technical & performance characteristic, electrical power, design, and function.

Also, the Indications for Use for the subject devices is identical to the predicate device (K111616) for endodontic and orthodontic procedure in dental oral use, and the reference devices (K161500, K110278) for screw-driver function in dental implant in prosthodontic treatment.

The electrical safety and performance testing performed on the subject device demonstrate that the difference in external design and some technological characteristics compared predicate device does not raise any new issues.

The sterilization validation performed on the subject device demonstrates that the difference in sterilization method does not raise any new issues. Any of difference (chuck design and lubricant) also does not raise any new issues of safety and effectiveness as compared to the predicate device.

Based on the comparison charts below and test results provided in this submission, we conclude that the subject device is substantially equivalent to the predicate device.

510(k) No.	Subject Device	Predicate Device	Reference Device 1	Reference Device 2	Comparison
	Not yet	K111616	K161500	K110278
Device Name	PRO M CLASS	E-CUBE	MEG-TORQ	Cordless Prosthodontic
Screwdriver with Torque
Calibration System, Model
iSD900
Manufacturer	Saeyang Microtech Co., Ltd.	Saeshin Precision Co., Ltd.	MICRO-NX Co., Ltd.	Nakanishi, Inc.
Regulation
Number	21 CFR 872.4200	21 CFR 872.4200	21 CFR 872.4200	21 CFR 872.4200	Same
Product Code	EKX	EKX	EKX	EKX	Same
Regulatory Class	Class I	Class I	Class I	Class I	Same
Use	RX only	RX only	RX only	RX only	Same
Indications for
Use Statement	The PRO M CLASS is used by dental
professionals for orthodontic and
endodontic procedures using a root
canal instrument and tightening and
loosening an abutment screw to fix and
remove the abutment on a dental
implant in prosthodontic treatment.	The E-CUBE is indicated for
use by dentists in standard
endodontic procedures
using rotary endodontic
files and rotary endodontic
drills (Gates-Glidden).	This product is a cordless
motor handpiece system
intended for tightening and
loosening an abutment
screw to fix and remove the
abutment on a dental
implant in prosthodontic
treatment.	This product is a cordless
motor handpiece system
intended for tightening and
loosening an abutment
screw to fix and remove the
abutment on a dental
implant in prosthodontic
treatment.	Similar 1)
Component	Contra-Angle Handpiece
Motor Handpiece
Charger
Adapter	Contra-Angle Handpiece
Motor Handpiece
Controller,
Adapter	Contra-Angle Handpiece
Motor Handpiece
Charger
Adapter	Contra-Angle Handpiece
Motor Handpiece
Charger	Same
Operational
Mode	Speed control, Torque control, Rotate
both forward/reverse operation	Speed control, Torque
control, Rotate both
forward/reverse operation	Speed control, Torque
control, Rotate both
forward/reverse operation	Speed control, Rotate both
forward/reverse operation	Same
Principle of
Operation	The motor turned by the power
converted into DC voltage by controller
delivers its turning power to the file
through spin to perform punching,
cutting and removing functions. The
hand-piece can be operated stopped
and set/adjusted on/in its speed,
torque and turning direction by
handling of the controller.	The motor turned by the
power converted into DC
voltage by controller
delivers its turning power to
the file through spin to
perform punching, cutting
and removing functions.
The hand-piece can be
operated stopped and
set/adjusted on/in its
speed, torque and turning
direction by handling of the
controller.	The motor turned by the
power converted into DC
voltage by controller
delivers its turning power
to the file through spin to
perform punching, cutting
and removing functions.
The hand-piece can be
operated stopped and
set/adjusted on/in its
speed, torque and turning
direction by handling of the
controller.	The motor turned by the power
converted into DC voltage by
controller delivers its turning power
to the file through spin to perform
punching, cutting and removing
functions. The hand-piece can be
operated stopped and
set/adjusted on/in its speed, torque
and turning direction by handling of
the controller.	Same
Electrical Safety	Complied with IEC 60601-1	Complied with IEC 60601-1	Complied with IEC 60601-1	Complied with IEC 60601-1	Same

ectromagnet Compatibility		omplied with IEC 60601-1-2				omplied with IEC 60601-1	omplied with IEC 60601-	Complied with IEC 60601	Same

evice Design – Motor Handpiece Battery Type		Li-Ion (DC 3.7 V, 800	nAH			None	i-Polyme	hium (DC 2.4V, 0.3V	Different 2)
		4:1			1:1	4:1
ាន សាសនា សាសនា សាសនា ន ការបោយសារ ប្រជាជាតិ ស្រុកស្រុក ប្រចាំប្រជាជាតិ	00010 5000 z	5 1901 EOO			3,000	3,250
				-		1.3
			160:1	-	-	-	None	-
			15-70	-	-	-	15-60	-
שלו או האירופי מערשים של מערכת משום של מערכת של המונים של המועד של המושב של המושב של המושב של המושב של המושב של המושב של המושב של המושב של המושב של המושב של המושב של המושב ש			5-35	।			5-35
	I			320:1	-	-		None
				15-25	1	1	-	15-25
וני שנים מורים חיצוניים				10-40	1			10-40

evice Design – Contra-Angle Handpier		JS303F, SUS420 Head and Chuck	(는
(			S303F, SUS42 ead and Chuc	Jnknowi	Jnknowi	Same
huk Desig			ype 1 by ISO 1797-1 ype 3 by ISO 1797-1 ype 3 by ISO 1797-1			ype 1 by ISO 1797-	ype 1 by ISO 1797-	ype 1 by ISO 1797	Same
Coupling Dimensio			omplied with ISO 3964			omplied with ISO 396	omplied with ISO 39	omplied with ISO 396	Same
terilizatic		utoclave by User at 135℃ for	Non-sterile			32°C for 4min		Non-sterile Lutoclave by User 1℃ for 20min or
32°C for 15mir	Different
evice Design – Charger & Adapte
Input		AC 100-240V, 50~60 Hz, 0.6A				100-240V, 47-63H	AC 100 ~ 240V, 50~60	AC 100 ~ 240V, 50~60 H	Different
ubrican
ាក កន្លង់ អ្នកន្ទនា រហូត ក្រុងប្រទេ ការចេញពី ព្រះបាទប្រយោ ។ សាខា សាសនា របស់ប្រយោ ។		na-Spray made by		K052700		Inknow	Jnknow	Jnknow	Different

Substantial Equivalence Discussion
Discussion
Similar 1)
The subject device has two main indications for use. The indications for use is based on the motor rotation speed and torque according to the gear ratio.
First indication for use is for orthodontic and endodontic procedures is the same as the predicate device (K111616)
Second indication for use is for tightening and loosening an abutment screw to fix and remove the abutment on a dental implant in prosthodontic treatment is the same as the reference devices (K161500, K110278).
Different 2)
The motor handpiece is supplied power from the internal rechargeable battery and battery voltage is the different.
The different was verified according to IEC 60601-1, IEC 80601-2-60 and IEC 62133-2. The testing results show that the difference does not raise any problems in the safety and effectiveness.
Similar 3)
Motor rotation speed as 2,000-10,000 rpm (on gear ratio 1:1) and 500-2,500 rpm (on gear ratio 4:1) are for orthodontic and endodontic procedures. It is similar to the predicate device (K111616).
Motor rotation speed as 15-70 rpm (torque 5-35 on gear ratio 160:1) is for prosthodontic treatment as tightening and loosening an abutment screw to fix and remove. It is similar to the reference device1 (K161500).
Motor rotation speed as 15-25 rpm (torque 10-40 on gear ratio 320:1) is for prosthodontic treatment as tightening and loosening an abutment screw to fix and remove. It is the same as the reference device2 (K110278).
Performance test (Bench test) according to ISO 14457 also was conducted. The testing results show that the difference does not raise any problems in the safety and effectiveness.
Different 4)
The Sterilization method is slightly different from the predicate device (K111616). The sterilization was validated according to ISO 17665-1 and the differences in sterilization methods show that it does not raise any problems in the safety and effectiveness.
Different 5)
The charger is supplied power from an AC/DC adapter. The power input of the AC/DC adapter is different from the predicate device (K111616). The different was verified according to IEC 60601-1, IEC 80601-2-60 and IEC 60601-1-2. The testing results show that the difference does not raise any problems in the safety and effectiveness.
Different 6)
The subject device uses a legally-marketed lubricant (K052700). It has been evaluated and cleared by FDA about the safety and effectiveness.
Conclusion
The PRO M CLASS is substantially equivalent to the predicate device and the reference devices in terms of intended use, technical & performance characteristic and function.
Also, the Indications for Use for the subject devices is identical to the predicate device (K111616) for endodontic and orthodontic procedure in dental oral use, and the reference devices (K161500, K110278) for screw-driver function in dental implant in prosthodontic treatment.
The electrical safety and performance testing performed on the subject device demonstrate that the difference in some technological characteristics compared predicate device and reference devices does not raise any new issues

The steriizitor perforned on the subject eleves that the diference in take an taise any niel ifse any nifaste, any nifines any nifines any nifines any nifines any nifine is c