Motor Handpiece and Control Unit (SDI10)

K251407 · Saeshin Precision Co., Ltd. · EBW · Jan 30, 2026 · Dental

Device Facts

• Record ID: K251407
• Device Name: Motor Handpiece and Control Unit (SDI10)
• Applicant: Saeshin Precision Co., Ltd.
• Product Code: EBW · Dental
• Decision Date: Jan 30, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

SDI10 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.

Device Story

SDI10 is a sensorless micro-motor system for dental handpieces; connects to dental unit chair (air unit). System comprises control unit, micro-motor, and AC/DC adapter. Device converts pneumatic output from dental treatment center into electrical control for motorized handpieces. Used in dental clinics by dental professionals for restoration, prophylaxis, and endodontic procedures. Provides rotational control (clockwise/counterclockwise), irrigation, and LED illumination. Enables precise control of handpiece speed and torque during dental procedures; benefits patient by facilitating efficient and accurate dental treatment.

Clinical Evidence

No clinical performance testing was performed. Substantial equivalence is supported by non-clinical bench testing, including biocompatibility (ISO 10993 series), electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and performance testing per ISO 14457.

Technological Characteristics

Brushless micro-motor system; internal coolant air; DC 40V power supply. Speed range 2,000–40,000 rpm; max torque 3Ncm. Complies with ISO 3964 for shanks. Includes irrigation system and LED optic attachment. Sterilization via moist heat (ISO 17665-1).

Indications for Use

Indicated for use in dentistry for restoration, prophylaxis, and endodontic procedures in patients requiring motorized dental handpiece intervention.

Regulatory Classification

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.

Predicate Devices

• ELEC-LED (EL-B40S, EL-B40L, EL-B40M, EL-B40I) (K201191)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

January 30, 2026

Saeshin Precision Co., Ltd.
% Sanghwa Myung
Regulatory Affair Specialist
E&M
D1474, PyeongCheon Arco Tower, 230, Simin-Daro, Dongan-gu
Anyangsi, Gyeonggido 14067
SOUTH KOREA

Re: K251407
Trade/Device Name: Motor Handpiece and Control Unit (SDI10)
Regulation Number: 21 CFR 872.4200
Regulation Name: Dental Handpiece And Accessories
Regulatory Class: Class I, reserved
Product Code: EBW
Dated: December 29, 2025
Received: December 29, 2025

Dear Sanghwa Myung:

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 (the 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 available 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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K251407 - Sanghwa Myung
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K251407 - Sanghwa Myung
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

MICHAEL E. ADJODHA -S

Michael E. Adjodha, MChE, RAC, CQIA
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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Motor Handpiece and Control Unit
Page 10 of 56

| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K251407 | ? |
| Please provide the device trade name(s). | | ? |
| Motor Handpiece and Control Unit (SDI10) | | |
| Please provide your Indications for Use below. | | ? |
| SDI10 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. | | |
| Please select the types of uses (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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SAESHIN

# 510(k) Summary

# K251407

Submitter: Saeshin Precision Co., Ltd.
# 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun, Daegu, 42921, Republic of Korea
Telephone: [phone]
Fax: [phone]
Email: [e-mail]

Contact: E&M
Regulatory Affair/Sang Hwa Myung Telephone: [phone]
FAX: [phone]
Cellphone: [phone]
E-mail: [e-mail]
Primary Contact: Sanghwa Myung

Date 510(k) summary prepared: January 29, 2026

Common Name: Motor Handpiece and Control Unit
Trade Name: Motor Handpiece and Control Unit (SDI10)
Classification: I
Product Code: EBW
Classification Panel: Dental
Regulation Numbers: 21 CFR 872.4200
Regulation Name: Dental handpiece and accessories

# Description of Device:

SDI10 can be connected to a handpiece and a dental unit chair. This device is a LED Optic attachment sensorless micro motor system that can be connected and used with a dental unit (air unit). It consists of a control unit, micro-motor and AC/DC adapter.

# Indication for use:

SDI10 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.

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# Predicate Device:

Manufacturer: MICRO-NX Co., Ltd.

510(k) Number: K201191

Trade/Device Name: 21 CFR 872.4200

Regulation Name: Dental handpiece and accessories

Regulatory Class: Class I

Product Code: EBW

Substantial Equivalence: Comparison table is as follows.

Table 1: Substantial equivalence comparison
1) Predicate Device

| Descriptive Information | Subject Device | Predicate Device | Comparison Comment |
| --- | --- | --- | --- |
| Manufacturer | Saeshin Precision Co., Ltd. | MICRO-NX Co., Ltd. | - |
| Device Name | SDI10 | ELEC-LED (EL-B40S, EL-B40L, EL-B40M, EL-B40I) | - |
| 510(k) number | K251407 | K201191 | - |
| Classification Product Code / Regulatory Number | EBW | EBW | - |
| Regulatory Class | Class I | Class I | - |
| Indications for Use | SDI10 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. | 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. | Same |
| Type of motor | Brushless, internal coolant air | Brushless, internal coolant air | Same |
| Device components | Control unit with hose and electrical motor | Control unit with hose and electrical motor | Same |
| Power supply voltage | DC 40V | AC 24V | Different #1 |
| Speed | 2,000 – 40,000 rpm | 1,000-40,000 rpm | Substantially Equivalent |
| Max. Torque | 3Ncm | 3Ncm | Same |

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| Rotation direction | clockwise / counterclockwise | clockwise / counterclockwise | Same |
| --- | --- | --- | --- |
| Spray Air Pressure | 2.5bar | 2.5bar | Same |
| Spray Water Pressure | 2bar | 2bar | Same |
| Irrigation system | Yes | 1) EL-B40S, EL- B40S, EL-B40I (Irrigation system, motor cooling air)
2) EL-B40M (only motor cooling air) | Substantially Equivalent |
| Light (Motor LED) | Yes | 1) Yes (EL-B40S, EL-B40L)
2) No (EL-B40I, EL-B40M) | Substantially Equivalent |
| Conformance with standards for shanks | Comply with ISO 3964 | Comply with ISO 3964 | Same |
| Rotation | Clockwise, Counterclockwise | Clockwise, Counterclockwise | Same |

## Differences between Subject and Predicate Device

Different #1 Power supply voltage

The input voltage of the subject device is DC 40V, while the input voltage of predicate device is AC 24V. The device safety and performance test were conducted according to IEC 60601-1 and IEC 60601-1-2. The differences do not raise different questions of safety and effectiveness.

## Discussion

The subject device is substantially equivalent to the predicate device with respect to indications for use, type of motor, device components, speed, max torque, rotation direction, spray air and water pressure.

## Biocompatibility:

Biocompatibility testing (cytotoxicity, sensitization, irritation) was conducted on the direct and indirect tissue contacting components in accordance with ISO 10993-1. The device materials have been confirmed to be biologically safe.

1) ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
2) ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
3) ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
4) ISO 10993-12 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
5) ISO 10993 -23 Biological evaluation of medical devices - Part 23: Tests for irritation
6) Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"

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# Non-clinical Performance Data:

- IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
- IEC 62366-1 Medial devices – Part 1: Application of usability engineering to medical devices
- IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
- IEC 80601-2-60 Medical electrical equipment – Part 2-60: Particular Requirements for The Basic Safety and Essential Performance of Dental Equipment
- ISO 14457 Dentistry – Handpieces and motors
- ISO 17665-1 Sterilization of health care products – moist heat – Part 1: requirements for the development, validation and routine control of a sterilization process for medical devices
- ISO 17664-1 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 1: Critical and semi-critical medical devices
- ISO 17664-2 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 2: Non-critical medical devices
- Cleaning, Sterilization, and Disinfection validation was provided per the FDA guidance document, “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling”
- Electromagnetic Compatibility testing and labeling was provided per the FDA guidance document, “Electromagnetic Compatibility (EMC) of Medical Devices”
- Software documentation was prepared per the FDA guidance document, “Content of Premarket Submissions for Device Software Functions”
- Use of International Standard ISO 10993-1, “Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process”

Clinical Data: No clinical performance testing was performed.

# Conclusion

The performance of SDI10 meets the requirements of the non-clinical bench testing conducted to support substantial equivalence. The subject device and the predicate device have the same indications for use, and similar operational principal, performance data. We conclude that the subject device is substantially equivalent to the predicate device.