← Product Code [EFB](/productcode/EFB) · K262144

# DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece (K262144)

_SETAGAYA SEIKI Co., Ltd. · EFB · Sep 23, 2026 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K262144

## Device Facts

- **Applicant:** SETAGAYA SEIKI Co., Ltd.
- **Product Code:** [EFB](/productcode/EFB.md)
- **Decision Date:** Sep 23, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.4200
- **Device Class:** Class 1
- **Review Panel:** Dental

## Indications for Use

DIAMED Handpiece is intended for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations, polishing teeth, and hygiene dentistry work. All the devices are autoclavable. DIAMED Airmotor is used to power various attachments which helps dental clinician perform various dental procedures. All the devices are autoclavable. DIAMED Airmotor Handpiece is an air-powered dental handpiece for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations, polishing teeth, and hygiene dentistry work. All the devices are autoclavable.

## Device Story

Air-powered dental handpieces and airmotors; used by trained dental professionals in clinical settings; input is compressed air; transforms air pressure into mechanical rotation for dental burs or attachments; output is rotational motion for tooth preparation, polishing, and hygiene work; devices are non-sterile and require steam autoclave sterilization between patients; clinical benefit is efficient removal of dental material and facilitation of restorative procedures.

## Clinical Evidence

No clinical data. Substantial equivalence demonstrated through bench testing, including biocompatibility (ISO 10993-1, -5, -10, -23), reprocessing validation (AAMI/ANSI/ISO 17665-1), and performance testing per ISO 14457:2017.

## Technological Characteristics

Air-driven dental handpieces and motors; materials include brass, bronze, aluminum, stainless steel with chrome/nickel plating; ISO 3964 Type E coupling; ISO 9168 Type 1/2 hose connection; steam autoclave sterilization; performance tested per ISO 14457:2017.

## Regulatory 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

- ND LOW SPEED AIRMOTOR AND HANDPIECE, HIGHSPEED AIRTURBINE HANDPIECE, E-TYPE STRAIGHT NOSECONE AND CONTRA ANGLE ([K073652](/device/K073652.md))
- MDK HANDPIECES ([K141886](/device/K141886.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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**FDA** U.S. FOOD & DRUG
ADMINISTRATION

September 23, 2026

SETAGAYA SEIKI Co., Ltd.
% Akiko Dohi
Senior Regulatory Consultant
Ken Block Consulting, LLC
3400 N Central Expy., Suite 100-265
Richardson, Texas 75080

Re: K262144

Trade/Device Name: DIAMED Handpiece; DIAMED Airmotor; DIAMED Airmotor Handpiece
Regulation Number: 21 CFR 872.4200
Regulation Name: Dental Handpiece And Accessories
Regulatory Class: Class I, reserved
Product Code: EFB, EGS
Dated: June 25, 2026
Received: June 25, 2026

Dear Akiko Dohi:

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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K262144 - Akiko Dohi

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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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

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 Management System Regulation (QMSR) (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

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K262144 - Akiko Dohi

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the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/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 -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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|  DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration **Indications for Use** | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 *See PRA Statement below.*  |
| --- | --- |

510(k) Number (if known)

K262144

Device Name

DIAMED Handpiece;

DIAMED Airmotor;

DIAMED Airmotor Handpiece

Indications for Use (Describe)

DIAMED Handpiece is intended for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations, polishing teeth, and hygiene dentistry work. All the devices are autoclavable.

DIAMED Airmotor is used to power various attachments which helps dental clinician perform various dental procedures. All the devices are autoclavable.

DIAMED Airmotor Handpiece is an air-powered dental handpiece for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations, polishing teeth, and hygiene dentistry work. All the devices are autoclavable.

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)

# CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

# *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/23)

Page 1 of 1

PSC Publishing Services (301) 443-6740

EF

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# SETAGAYA SEIKI Co.,Ltd.

Head Office:1945 Onozi,Machida city,Tokyo,195-0064,Japan TEL:81-42-735-1531 FAX:81-42-735-3726
Yamagata Factory:4862-11 5 chome,Hachimanpara,Yonezawa city,Yamagata,992-1128,Japan
TEL:81-238-28-2255 FAX:81-238-28-2355

# 510(k) Summary – K262144

Applicant/ Sponsor: SETAGAYA SEIKI Co., Ltd.

Contact Person: Mr. Shigehiro Sasaki
General Manager
TEL: 81-238-28-2255
FAX: 81-238-28-2355
sasaki@setagayaseiki.co.jp

Date Prepared: September 11, 2026

Subject Device Manufacturer: SETAGAYA SEIKI Co., Ltd.
Trade Name: DIAMED Handpiece;
DIAMED Airmotor;
DIAMED Airmotor Handpiece
Classification Name: Handpiece, Air-Powered, Dental
Classification Product Code: EFB
Subsequent Product Codes: EGS
Regulation Number: 21 CFR 872.4200
Common Name: Dental Handpiece and Accessories
Class: I

Primary Predicate Device: Clearance: K073652, 03/20/2008
Manufacturer: NAKAMURA DENTAL HANDPIECE MFG. CO., LTD.
Trade Name: ND LOW SPEED AIRMOTOR AND HANDPIECE,
HIGHSPEED AIRTURBINE HANDPIECE, E-TYPE
STRAIGHT NOSECONE AND CONTRA ANGLE
Classification Name: Handpiece, Air-Powered, Dental
Classification Product Code: EFB
Subsequent Product Codes: EGS
Regulation Number: 21 CFR 872.4200
Common Name: Dental Handpiece and Accessories
Class: I

Secondary Predicate Device: Clearance: K141886, 05/13/2015
Manufacturer: Modern Korea Co., Ltd
Trade Name: MDK HANDPIECES
Classification Name: Handpiece, Air-Powered, Dental
Classification Product Code: EFB
Regulation Number: 21 CFR 872.4200
Common Name: Dental Handpiece and Accessories
Class: I

Device Description The proposed devices for this submission include the DIAMED Handpiece, DIAMED Airmotor, and DIAMED Airmotor Handpiece. All proposed devices are driven by air and are intended to be used solely by well trained professionals in the field of general dentistry. The subject devices are provided non-sterile and must be cleaned and sterilized prior to first use and after each patient use.

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# SETAGAYA SEIKI Co.,Ltd.

Head Office/1945 Onozi,Machida city,Tokyo,195-0064,Japan TEL 81-42-735-1531 FAX/81-42-735-3726  
 Yamagata Factory/4862-11 5 chome,Hachimanpara,Yonezawa city,Yamagata,992-1128,Japan  
 TEL 81-238-28-2255 FAX/81-238-28-2355

## Indications for Use Statement

DIAMED Handpiece is intended for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations, polishing teeth, and hygiene dentistry work. All the devices are autoclavable.

DIAMED Airmotor is used to power various attachments which helps dental clinician perform various dental procedures. All the devices are autoclavable.

DIAMED Airmotor Handpiece is an air-powered dental handpiece for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations, polishing teeth, and hygiene dentistry work. All the devices are autoclavable.

## Summary of Technological Characteristics:

The proposed device, primary predicate, and secondary predicate have similar technological features. The Indications for Use for all devices describe the same intended clinical purpose, despite minor wording differences. The indications for use statement for the proposed handpieces collectively encompass the clinical procedures represented in that of the predicate handpieces. Additional descriptive elements in the primary predicate’s Indications for Use, such as power source, compatible burs, or gear ratio, do not alter the intended clinical purpose. This difference does not cause new risks. The Indications for Use statement for the proposed and primary predicate airmotors are identical.

The proposed and primary or secondary predicate devices are equivalent or similar across all key technological characteristics. All devices use the same operational mode, lack fiber optics (where applicable), and include equivalent chuck types (where applicable). Material composition was confirmed biocompatible per ISO 10993. The chuck mechanism, bur retention force, and maximum rotation speed are slightly different, and these differences were evaluated through ISO 14457 testing and shown to be as safe and as effective as the predicate devices.

Based on the similarities and the differences that were evaluated through FDA-recognized standards and determined not to introduce new risks, the proposed, primary predicate, and secondary predicate handpieces are considered substantially equivalent.

A brief summary of the regulatory and technological characteristics in comparison to those of the primary and secondary predicate devices is as follows:

|   | Subject Device | Primary Predicate Device | Secondary Predicate Device  |
| --- | --- | --- | --- |
|   | DIAMED Handpiece DIAMED Airmotor DIAMED Airmotor Handpiece | K073652 ND Low Speed Airmotor and Handpiece, Highspeed Airturbine Handpiece, E-Type Straight Nosecone and Contra Angle | K141886 MDK handpieces – Low speed handpieces  |
|  **Regulatory Characteristics**  |   |   |   |
|  Classification Name | Handpiece, Air-Powered, Dental | Handpiece, Air-Powered, Dental | Handpiece, Air-Powered, Dental  |
|  Regulation Number | 872.4200 | 872.4200 | 872.4200  |
|  Classification Product Code | EFB | EFB | EFB  |
|  Subsequent Product Code | EGS | EGS | N/A  |
|  Medical Specialty | Dental | Dental | Dental  |
|  Rx or OTC Use | Rx Only | Rx Only | Rx Only  |
|  Clinical Area | General Dentistry and Dental Hygiene | General Dentistry and Dental Hygiene | General Dentistry and Dental Hygiene  |
|  Indications for Use Statement | DIAMED Handpiece is intended for removing carious material and excess filling material, cavity and crown preparation, root canal | ND E-type contra angle is powered by either low speed airmotor or electric micromotor for removing carious material and excess filling | MDK low-speed handpieces used for teeth cutting, cavity and crown preparation, restorations and polishing teeth.  |

510(k) Summary – K262144

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# SETAGAYA SEIKI Co.,Ltd.

Head Office/1945 Onozi,Machida city,Tokyo,195-0064,Japan TEL 81-42-735-1531 FAX/81-42-735-3726

Yamagata Factory/4862-11 5 chome,Hachimanpara,Yonezawa city,Yamagata,992-1128,Japan

TEL 81-238-28-2255 FAX/81-238-28-2355

|   | Subject Device | Primary Predicate Device | Secondary Predicate Device  |
| --- | --- | --- | --- |
|   | DIAMED Handpiece DIAMED Airmotor DIAMED Airmotor Handpiece | K073652 ND Low Speed Airmotor and Handpiece, Highspeed Airturbine Handpiece, E-Type Straight Nosecone and Contra Angle | K141886 MDK handpieces – Low speed handpieces  |
|   | preparations, finishing tooth preparations, restorations, polishing teeth, and hygiene dentistry work. All the devices are autoclavable. DIAMED Airmotor Handpiece is an air-powered dental handpiece for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations, polishing teeth, and hygiene dentistry work. All the devices are autoclavable. | material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations and polishing teeth. EC-20L and EC-30BL are 1:1 ratio, EG-20L is 4:1 ratio, and EGG-20L is 16:1 ratio. All of the devices are autoclavable. ND u-type prophylaxis angle is used mounted on U-type nose attachment powered by either lowspeed airmotor or electric micromotor for hygiene dentistry work. All the devices are fully autoclavable. ND straight nosecone is powered by either lowspeed airmotor or electric micromotor for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations and polishing teeth. ES-30A is E-type 1:1 ratio, ESG-30AR is E-type 4:1 ratio, and MWS-30A is Midwest-type 1:1 ratio. All the devices are autoclavable. They accept 2.35mm (3/32") standard burs and can have prophy angles mounted. ND air powered low speed airmotor is used to power various U-type attachment which helps dental clinician perform the hygiene dentistry work. All the devices are autoclavable. | All the devices are designed for use by a trained professional in the field of general dentistry.  |
|   | DIAMED Airmotor is used to power various attachments which helps dental clinician perform various dental procedures. All the devices are autoclavable. | ND air powered low speed airmotor is used to power various attachment which helps dental clinician perform various dental procedures. All the devices are autoclavable. | N/A  |
|  **Handpieces Technical Characteristics Comparison**  |   |   |   |
|  Model | DIAMED Handpiece E-type contra-angle: • DIAMED Handpiece E-type Push Button Contra Angle (Model: H5AB00, H5AB15, H5AB16, H6AB00, H6AB15, H6AB16) • DIAMED Handpiece E-type Latch Contra Angle (Model: H7AB00, H8AB00, H9AB00, H7AB15, H8AB15, H9AB15, H7AB16, H8AB16, H9AB16) DIAMED Handpiece E-type prophy contra angle: • DIAMED Handpiece E-type Prophy Contra Angle (Model: HHAB00, HHAB16, HHAB16) • DIAMED Handpiece E-type Vertical Reciprocating Contra Angle (Model: HLAB00, HLAB15, HLAB16) | ND E-type Contra Angle (Model: EC-20L, EC-30BL, EG-20L, EGG-20L) ND U-type Prophylaxis Angle (Model: RA-10PS, RA-10PK, RA-50PS, RA-50PK, DC-10L, DU-20L) ND Straight Nosecone (Model: ES-30A, ESG-30AR, MWS-30A) ND Low speed Airmotor Handpiece (Model: MD-50M, MD-50B, MD-20M, MD-20B, MP-40M) | MDK handpieces – Low speed handpieces (10 models)  |

510(k) Summary – K262144

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# SETAGAYA SEIKI Co.,Ltd.

Head Office/1945 Onozi,Machida city,Tokyo,195-0064,Japan TEL 81-42-735-1531 FAX/81-42-735-3726

Yamagata Factory/4862-11 5 chome,Hachimanpara,Yonezawa city,Yamagata,992-1128,Japan

TEL 81-238-28-2255 FAX/81-238-28-2355

|   | Subject Device | Primary Predicate Device | Secondary Predicate Device  |
| --- | --- | --- | --- |
|   |  DIAMED Handpiece DIAMED Airmotor DIAMED Airmotor Handpiece | K073652 ND Low Speed Airmotor and Handpiece, Highspeed Airturbine Handpiece, E-Type Straight Nosecone and Contra Angle | K141886 MDK handpieces – Low speed handpieces  |
|   | DIAMED Handpiece E-type Straight nose cone (Model: S0A) DIAMED Airmotor Handpiece (Model: M4A, MBA, SCAMCA) |  |   |
|  Operational Mode | Air driven | Electric or air driven | Air driven  |
|  Fiber optics | No | No | With or without built-in light system  |
|  Type of chuck | Push-button, latch-type, screw-in, tip-lock, and mechanical (bur-lock-ring) chuck options | Information not available | Push button, latch, screw, snap-on or tip-lock chuck options  |
|  Composition of materials | Brass, Bronze, Aluminum, Stainless Steel, chrome-plating, nickel-plating | Information not available | Stainless steel and titanium  |
|  Bur retention force | 32N | Information not available | 30N  |
|  Maximum rotation speed | Up to 40,000 rpm | Up to 30,000 rpm | Up to 20,000 rpm  |
|  Accessories | Head opener (Head Cap Wrench): H5AB00, H5AB15, H5AB16, H6AB00, H6AB15, H6AB16 Head opener (Cap Wrench) : H7AB00, H8AB00, H9AB00, H7AB15, H8AB15, H9AB15, H7AB16, H8AB16, H9AB16 Connector for inserting lubricant (E-type Spray Nozzle): H5AB00, H5AB15, H5AB16, H6AB00, H6AB15, H6AB16, H7AB00, H8AB00, H9AB00, H7AB15, H8AB15, H9AB15, H7AB16, H8AB16, H9AB16 | Information not available | Head opener for the latch type, Connector for inserting lubricant, External Spray Tubing with nozzle  |
|  Lubricant | NSA PANA-SPRAY Plus (K163483) | Lubricant oil (product name not specified) | Pana-Spray (K052700)  |
|  Sterilization | Steam autoclave method | Steam autoclave method | Steam autoclave method  |
|  **Airmotor Technical Characteristics Comparison**  |   |   |   |
|  Model | DIAMED Airmotor (Model: M0A, M2A, M3A, M8A) | ND Low Speed Airmotor (Model: ME-20M, ME-20B, ME-80M, ME-80B) | N/A  |
|  Operational Mode | Air driven | Air driven  |   |
|  Max Air Consumption | Less 66NL/min | Information not available  |   |
|  Hose Connection Type | ISO 9168 Type 1 and 2 | Information not available  |   |
|  Coupling Type | ISO 3964 Type E | Information not available  |   |
|  Composition of materials (Airmotor) | Aluminum, stainless steel, bronze | Information not available  |   |
|  Composition of materials (Waterpipe) | Brass, nickel-plating | Information not available  |   |
|  Operating pressure | 0.25MPa | 0.2MPa  |   |
|  Maximum rotation speed | 25,000 rpm | 5,000 rpm: ME-80M, ME-80B 20,000rpm: ME-20M, ME-20B  |   |
|  Spray Air Supply | N/A: M0A 1.5NL/min: M2A, M3A, M8A | Information not available  |   |
|  Water Supply | N/A: M0A 50mL/min: M2A, M3A, M8A | Information not available  |   |
|  Accessories | N/A | Information not available  |   |
|  Lubricant | NSA PANA-SPRAY Plus (K163483) | Lubricant oil (product name not specified)  |   |
|  Sterilization | Steam autoclave method | Steam autoclave method  |   |

510(k) Summary – K262144

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# SETAGAYA SEIKI Co.,Ltd.

Head Office/1945 Onozi,Machida city,Tokyo,195-0064,Japan TEL 81-42-735-1531 FAX/81-42-735-3726

Yamagata Factory/4862-11 5 chome,Hachimanpara,Yonezawa city,Yamagata,992-1128,Japan

TEL 81-238-28-2255 FAX/81-238-28-2355

Summary of Non-Clinical/ Test Data:

A series of non-clinical tests were conducted to verify that the proposed devices meet all design specifications and are substantially equivalent to the predicate devices, in accordance with FDA-recognized standards and applicable FDA guidance documents.

Biocompatibility was evaluated in accordance with ISO 10993, including the following parts:

ISO 10993-1: 2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 10993-5: 2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-10: 2021 Biological evaluation of medical devices - Part 10: Tests for skin sensitization
ISO 10993-23: 2021 Biological evaluation of medical devices - Part 23: Tests for irritation

Reprocessing was validated in accordance with:

FDA guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling,
AAMI/ANSI/ISO 17665-1:2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

Performance testing was conducted in conformance with ISO 14457:2017, Dentistry—Handpieces and Motors.

Clinical Testing:

No clinical testing was required as non-clinical testing should be sufficient to demonstrate that the proposed device works as intended.

Conclusion:

Setagaya Seiki Co., Ltd. considers the proposed device to be substantially equivalent to the predicate devices listed above. This conclusion is based on the similarities in application/intended use, principles of operation, functional design, and established medical use.

510(k) Summary – K262144

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**Source:** [https://fda.innolitics.com/device/K262144](https://fda.innolitics.com/device/K262144)

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