Who is the manufacturer of Dental Electric Motor?

Guilin Woodpecker Medical Instrument Co., Ltd. filed the 510(k) submission for Dental Electric Motor (K203706).

What is the FDA product code for Dental Electric Motor?

EBW. It is classified under 21 CFR 872.4200 as a Class 1 device in the Dental panel.

What is the regulatory pathway for Dental Electric Motor?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Dental Electric Motor?

A-dec NLZ electric motor system (K163131).

Who can help prepare an FDA 510(k) submission like Dental Electric Motor?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Dental Electric Motor

K203706 · Guilin Woodpecker Medical Instrument Co., Ltd. · EBW · Jan 13, 2022 · Dental

Device Facts

Record ID	K203706
Device Name	Dental Electric Motor
Applicant	Guilin Woodpecker Medical Instrument Co., Ltd.
Product Code	EBW · Dental
Decision Date	Jan 13, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.4200
Device Class	Class 1
Attributes	Therapeutic

Intended Use

The MT2 dental electric motor consists of main unit, motor, motor tail, power adapter and power cord. It is intended for use in general dental applications such as: cutting a tooth for cavity preparation, crown preparation, crown finishing, inlay, filing, polishing, prophylaxis and endodontic treatment. The Dental Electric Motor can be used with ISO E-type a straight, right-angle or contra-angle handpiece attachment of equal, gear-reducing, or gear increasing speed. The contra-angle handpieces (model: WJ-15, WJ-15L) are driven by a micro-motor to rotate at a specified speed, so as to drive the dental bur. It is applicable to drilling and grinding in dental surgery.

Device Story

MT2 Dental Electric Motor is a control unit system comprising a main unit, DC electric micromotor, motor tail, power adapter, and power cord. It connects to an AC power supply and drives a DC micromotor; speed and on/off functions are regulated via a dental unit foot control (not included). The device accepts ISO E-type straight, right-angle, or contra-angle handpieces (e.g., WJ-15, WJ-15L) to drive dental burs for cutting, grinding, and polishing. Used in dental clinics by dental professionals. The system provides low-voltage DC power to the handpiece, which may include LED lighting. The output is mechanical rotation of the dental bur, enabling the clinician to perform restorative and surgical dental procedures. Benefits include precise control of motor speed and torque for various dental applications.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including electrical safety (IEC 60601-1, IEC 80601-2-60), EMC (IEC 60601-1-2), biocompatibility (ISO 10993-5, ISO 10993-10), and sterilization validation (ISO 17665-1).

Technological Characteristics

System includes main control unit, DC micromotor (aluminum alloy exterior), and power adapter (100-240Vac input, 30V DC output). Supports ISO 3964 E-type handpieces. Features LED lighting, forward/reverse rotation, and 2,000-40,000 rpm speed range. Sterilization via steam (autoclave) per ISO 17665-1. Software is moderate level of concern.

Indications for Use

Indicated for general dental applications including cavity preparation, crown preparation/finishing, inlay, filing, polishing, prophylaxis, endodontic treatment, and dental surgery drilling/grinding. Used with ISO E-type handpieces.

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

A-dec NLZ electric motor system (K163131)

Reference Devices

General Cutting Contra Handpiece (K182999)
NSK Pana-Spray (K052700)
NSK PANA SPRAY Plus (K163483)

Related Devices

K990954 — ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET · Nsk Nakanishi, Inc. · Jun 9, 1999
K032572 — A-DEC/W&H ELECTRIC MOTOR, MODEL EA-50LT · A-Dec, Inc. · Dec 3, 2003
K202075 — Dental Electric Motor · Foshan Cicada Dental Instrument Co, Ltd. · Mar 11, 2022
K992648 — ROTARY MASTER · J. Morita USA, Inc. · Jan 31, 2000
K040153 — I-TEC PORTABLE DENTAL OPERATORY · Indigenous Peoples Technology and Education Center · May 21, 2004

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that 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. January 13, 2022 Guilin Woodpecker Medical Instrument Co., Ltd. % Field Fu Senior Consultant Shenzhen Joyantech Consulting Co., Ltd. Block A, Zhongguan Times Square, Liuxian Avenue, Xili Town, Nanshan District Shenzhen, Guangdong CHINA Re: K203706 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, EGS Dated: December 7, 2021 Received: December 20, 2021 Dear Field Fu: 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. {1}------------------------------------------------ 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 (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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K203706 Device Name Dental Electric Motor #### Indications for Use (Describe) The MT2 dental electric motor consists of main unit, motor tail, power adapter and power cord. It is intended for use in general dental applications such as: cutting a tooth for cavity preparation, crown finishing, inlay, filing, polishing, prophylaxis and endodontic treatment. The Dental Electric Motor can be used with ISO E-type a straight, right-angle or contra-angle handpiece attachment of equal, gear-reducing, or gear increasing speed. The contra-angle handpieces (model: WJ-15, WJ-15L) are driven by a micro-motor to rotate at a specified speed, so as to drive the dental bur. It is applicable to drilling and grinding in dental surgery. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | X 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." {3}------------------------------------------------ ## 510(k) Summary # K203706 This summary of 510(K) safety and effectiveness information is submitted As Required by requirements of SMDA and 21 CFR §807.92. # 5.1 Administrative Information | Date of Summary prepared | January 11, 2022 | |--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer information | Company title: Guilin Woodpecker Medical Instrument Co., Ltd. | | | Company address: Information Industrial Park, Guilin National High- Tech Zone, Guilin, Guangxi, 541004, China Contact person: Jiakang Ning Phone: +86 7735873198 Fax: +86-7735822450 E-mail:zmnbg03@glwoodpecker.com | | Submission Correspondent | Shenzhen Joyantech Consulting Co., Ltd. Address: 1713A, 17th Floor, Block A, | | Image: [logo]卓远天成 | Zhongguan Times Square, Liuxian Avenue, Xili Town, Nanshan District, Shenzhen, Guangdong Province, China. Contact person: Mr. Field Fu E-Mail:field@cefda.com; | | Establishment registration number | 3005581016 | # 5.2 Device Information | Type of 510(k) submission: | Traditional | |----------------------------|--------------------------------------| | Trade Name: | Dental Electric Motor | | Model: | MT2 | | Classification name: | Controller, Foot, Handpiece and Cord | | Regulation Name: | Dental Handpiece and Accessories | {4}------------------------------------------------ | Review Panel: | Dental | |--------------------------|----------| | Product Code: | EBW | | Additional Product Code: | EGS | | Device Class: | I | | Regulation Number: | 872.4200 | ### 5.3 Predicate Device Information | Primary predicate device | | |--------------------------|----------------------------------| | Sponsor: | Nakanishi, Inc. | | Device: | A-dec NLZ electric motor system | | 510(K)Number: | K163131 | | Reference device | | | Sponsor: | Nakanishi, Inc. | | Device: | General Cutting Contra Handpiece | | 510(K)Number: | K182999 | ### 5.4 Device Description The MT2 dental electric motor consists of main unit, motor, motor tail, power adapter and power cord. It is intended for use in general dental applications such as: cutting a tooth for cavity preparation, crown preparation, crown finishing, inlay, filing, polishing, prophylaxis and endodontic treatment, with use of a straight, rightangle or contra-angle handpiece attachment of equal, gear-reducing, or gear increasing speed. Dental Electric Motor (model: MT2) is a control unit, which is connected to an AC power supply and a handpiece hose, that drives a DC electric micromotor, and turns on or off or regulates the speed of the motor by the foot control of the dental unit. The foot switch is not included in the control unit. It is used together with a handpiece attachment. It provides a low voltage DC power supply for the handpiece attachment with light. The device is for prescription use. {5}------------------------------------------------ ### 5.5 Indications for Use The MT2 dental electric motor consists of main unit, motor, motor tail , power adapter and power cord. It is intended for use in general dental applications such as: cutting a tooth for cavity preparation, crown preparation, crown finishing, inlay, filing, polishing, prophylaxis and endodontic treatment. The Dental Electric Motor can be used with ISO E-type a straight, right-angle or contra-angle handpiece attachment of equal, gear-reducing, or gear increasing speed. The contra-angle handpieces (model: WJ-15, WJ-15L) are driven by a micro-motor to rotate at a specified speed, so as to drive the dental bur. It is applicable to drilling and grinding in dental surgery. # 5.6 Technological characteristics of the subject device compared to the predicate device | Item | Subject Device | Primary Predicate Device(K163131) | Reference device(K182999) | Remarks | |-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------| | Product Code | EBW, EGS | EBW | EGS | Identic al | | Regulation No. | 872.4200 | 872.4200 | 872.4200 | Identic al | | Class | I | I | I | identic al | | Indication for use | The MT2 dental electric motor consists of main unit, motor, motor tail, power adapter and power cord. It is intended for use in general dental applications such as: cutting a tooth for cavity preparation, crown preparation, crown finishing, inlay, filing, polishing, prophylaxis and endodontic treatment. The Dental Electric Motor can be used with ISO E-type a straight, right-angle or | The A-dec NLZ electric motor system is comprised of a control unit that drives a direct current (DC) electric micromotor that is activated by means of a foot control. It is intended for use in general dental applications such as: cutting a tooth for cavity preparation. Crown | The General Cutting Contra Handpiece is powered by either an air-motor or electric micromotor for use in general dentistry. The device is intended for cutting and grinding teeth, cavity preparations, tooth and crown | Simila r (Discu ssion 1) | | Item | Subject Device | Primary Predicate Device(K163131) | Reference device(K182999) | Remarks | | | contra-angle handpiece attachment of equal, gear-reducing, or gear increasing speed. The contra-angle handpieces (model:WJ- 15, WJ-15L) are driven by a micro-motor to rotate at a specified speed, so as to drive the dental bur. It is applicable to drilling and grinding in dental surgery. | preparation, crown finishing, inlay, filing, polishing, prophylaxis and endodontic treatment, with use of a straight, right- angle or contra- angle ISO E-type handpiece attachment of equal, gear-reducing, or gear-increasing speed. | preparations, finishing and trimming teeth and filling materials and removal of crowns and filling materials. | | | Dental electric Motor | | | | | | Drive | Electric-micromotor | Electric-micromotor | NA | Identical | | Components | Main unit, DC adapter, DC cord, motor, motor tail | Motor controller, Electric micromotor, Motor tubing | NA | Identical | | Power source | AC/DC Adapter: Power supply input:100-240Vac, 50/60Hz, 2.5A Power supply output: DC30V, 3.0A | --- | NA | --- | | Size | Main unit: W165.5 x D129.7 x H77.6mm Motor: DΦ22 x H76.7mm Motor tail: Length: 1800mm | Motor controller: D78.5 x W148.0 x H43.0mm Motor: Length: 31mm, Diameter: Φ20.1(Front), Φ22.1(Rear) Motor tubing: Length: NLZ CDAS: 1600mm NLZ CDAI: 2080mm | NA | Different (Discussion 2) | | Material of Motor exterior | Aluminum alloy | Titanium | NA | Different (Disc | | Item | Subject Device | Primary Predicate Device(K163131) | Reference device(K182999) | Remarks | | Light | LED | LED | NA | Identical | | Rotation Speed | 2,000-40,000 rpm | 1,000 - 40,000 rpm | NA | Similar(Discussion 2) | | Rotation direction | Forward and reverse | Forward and reverse | NA | Identical | | Coolant mechanism | Coolant air | Coolant air | NA | Identical | | Available Handpiece type | E-type (ISO 3964) | E-type (ISO 3964) | NA | Identical | | Usage environment | Temperature: 5-40°C, Humidity: 30-75% | Temperature: 0 - 40°C, Humidity: 30-75% | NA | Similar(Discussion 2) | | Handpiece | | | | | | Operational modes | Air-power | NA | Air-power | Identical | | Optical fiber | WJ-15: without light WJ-15L: with light | NA | With light, without light | Identical | | Type of chuck | Mechanical type chuck | NA | Mechanical type chuck | Identical | | Coupling dimensions | Middle (ISO 3964- 2016) | NA | ISO 3964 (EN ISO 3964) Standard Coupling | Identical | | Material of handpiece | Copper, Stainless steel | NA | Titanium | Different (Discussion 2) | | Shanks for rotary instruments | Type3,Φ1.6mm drill ( ISO 1797-1-2011) | NA | Type 1, Type 3 | Identical | | Item | Subject Device | Primary Predicate Device(K163131) | Reference device(K182999) | Remarks | | Gear Ratio Max rotation speed (handpiece) | 1:5 Increasing- 200,000 min-1 | NA | 16:1 Reduction- 2,500 min-1 10:1 Reduction- 4,000 min-1 4:1 Reduction- 10,000 min-1 1:1 Direct Drive- 40,000 min-1 1:5 Increasing- 200,000 min-1 | Identical | | Lubricant | NSK Pana-Spray (K052700) | NA | NSK PANA SPRAY Plus (K163483) | Identical | | Sterilization | Sterilized by user (Steam sterilization) | Sterilized by user (Steam sterilization) | Sterilized by user (Steam sterilization) | Identical | | Sterilization Validation Standard | ANSI/AAMI/ISO 17665-1:2006 | ANSI/AAMI/ISO 17665-1:2006 | ANSI/AAMI/ISO 17665-1:2006 | Identical | ### Comparison to predicate device: {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ Discussion 1: The predicate device is only a motor system. while the subject device includes a motor system and handpiece. Therefore, the intended use of the two is a little different. In order to be equivalent, we have added a reference device(K182999). Discussion 2: In the comparison table, there are some differences between the subject device and the predicate device, such as the size and the materials of the considered that the differences did not affect the identical principles of operation between the subject device and the predicate device. And the differences would not cause new risk to users and patients. Performance testing including Biocompatibility testing, Electric safety and EMC testing, bench testing was performed in order to demonstrate substantial equivalence to the predicate device. Also, sterilization validation and software validation were performed in accordance with FDA Guidance. The subject device met all the requirements of the standards. Therefore, the subject device demonstrated substantial equivalence to the predicate device. Note1: DC adaptor meets IEC 60601-1 standard. ## 5.7 Brief discussion of the nonclinical tests The subject device conforms to the following standards: IEC 60601-1:2005+AM1:2012 Medical Electrical Equipment - Part 1: General {9}------------------------------------------------ Requirements For Basic Safety And Essential Performance. IEC 60601-1-2:2014 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 : 2019 Medical Electrical Equipment - Part 2-60: Particular Requirements For The Basic Safety And Essential Performance Of Dental Equipment 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 Irritation and Skin Sensitization. ISO 14457: 2017 Dentistry- Handpieces and motors. Software Documentation of a MODERATE level of concern was provided per FDA Software Guidance titled: "Guidance for Industry and FDA Staff- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. Cleaning and Sterilization Validation of the Contra-Angle and Motor and High-Level Disinfection Validation for the Motor Tubing were provided per FDA Reprocessing Guidance titled: "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - Guidance for Industry and Food and Drug Administration Staff. ## 5.8 Brief discussion of clinical tests N/A. #### 5.9 Other information (such as required by FDA guidance/Test) The FDA Dental Handpiece Guidance titled: "Guidance for Industry and FDA Staff - Dental Handpieces - Premarket Notification [510(k)] Submissions," available at https://www.fda.gov/media/71432/download. {10}------------------------------------------------ ## 5.10 Conclusions The differences between subject device and predicate/reference devices do not affect the safety and effectiveness of the subject devices. Thus, the subject device is substantially equivalent to the predicate device.