(391 days)
No
The description focuses on the mechanical and electrical components of a dental motor and handpiece, with no mention of AI or ML capabilities.
No
The device is described as a dental electric motor intended for general dental applications like cutting, grinding, and polishing, which are procedural rather than therapeutic actions aimed at treating a disease or disorder.
No
The device is described for use in general dental applications involving cutting, grinding, polishing, and endodontic treatments. Its function is to drive handpieces for these procedures, not to diagnose conditions.
No
The device description explicitly lists hardware components such as a main unit, motor tail, power adapter, power cord, and a DC electric micromotor. It also mentions being used with handpiece attachments.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device's function as a dental electric motor for mechanical procedures within the mouth (cutting, grinding, polishing, etc.). This is a therapeutic/surgical function, not a diagnostic one.
- Device Description: The description reinforces its role in driving dental handpieces for physical manipulation of teeth and surrounding structures.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
EBW, EGS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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) |
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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
- |
| 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- -
| 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.
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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.