(391 days)
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.
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.
The provided text describes a 510(k) premarket notification for a Dental Electric Motor (model MT2). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through extensive trials. Therefore, the information typically requested in your prompt (e.g., effect size with AI assistance, expert qualifications for ground truth in a test set, MRMC studies) is generally not applicable to this type of regulatory submission for this device.
Based on the provided text, here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly present acceptance criteria in a table format with corresponding device performance metrics in the way you might expect for a diagnostic or AI-powered device. Instead, substantial equivalence is claimed based on comparing the technological characteristics of the subject device to predicate and reference devices, and conformity to recognized standards.
The "acceptance criteria" for this submission are primarily demonstrating that the device meets relevant safety and performance standards and that any differences from a predicate device do not raise new questions of safety or effectiveness.
Table: Comparison of Subject Device to Predicate/Reference Devices (from text, modified for clarity to show "acceptance criteria" indirectly)
| Item | Subject Device (MT2 Dental Electric Motor) | Primary Predicate Device (K163131: A-dec NLZ electric motor system) | Reference Device (K182999: General Cutting Contra Handpiece) | "Acceptance Criterion" (Implied: Demonstrated Substantial Equivalence) |
|---|---|---|---|---|
| Product Code | EBW, EGS | EBW | EGS | Identical to predicate/reference codes |
| Regulation No. | 872.4200 | 872.4200 | 872.4200 | Identical to predicate/reference |
| Class | I | I | I | Identical to predicate/reference |
| Indications for Use | General dental applications (cutting, preparation, finishing, inlay, filing, polishing, prophylaxis, endodontic treatment); usable with ISO E-type handpiece attachments. Contra-angle handpieces for drilling/grinding. | General dental applications (cutting, preparation, finishing, inlay, filing, polishing, prophylaxis, endodontic treatment); usable with ISO E-type handpiece attachments. | General dentistry (cutting, grinding, cavity preparations, finishing, trimming, material removal). | Similar (Differences discussed and justified not to affect equivalence) |
| Drive | Electric-micromotor | Electric-micromotor | NA | Identical to predicate |
| Components | Main unit, DC adapter, DC cord, motor, motor tail | Motor controller, Electric micromotor, Motor tubing | NA | Identical principle of operation |
| Power source | AC/DC Adapter: 100-240Vac; Output: DC30V, 3.0A | --- | NA | Meets relevant electrical safety standards |
| Size | Main unit: W165.5 x D129.7 x H77.6mm; Motor: DΦ22 x H76.7mm; Motor tail: 1800mm | Motor controller: D78.5 x W148.0 x H43.0mm; Motor: Length: 31mm, Diameter: Φ20.1(Front), Φ22.1(Rear); Motor tubing: 1600mm/2080mm | NA | Different but justified not to affect principle of operation or new risk |
| Material of Motor exterior | Aluminum alloy | Titanium | NA | Different but justified not to affect principle of operation or new risk |
| Light | LED | LED | NA | Identical to predicate |
| Rotation Speed | 2,000-40,000 rpm | 1,000 - 40,000 rpm | NA | Similar (Discussion 2 states differences do not affect identical principles) |
| Rotation direction | Forward and reverse | Forward and reverse | NA | Identical to predicate |
| Coolant mechanism | Coolant air | Coolant air | NA | Identical to predicate |
| Available Handpiece type | E-type (ISO 3964) | E-type (ISO 3964) | NA | Identical to predicate |
| Usage environment | Temperature: 5-40°C, Humidity: 30-75% | Temperature: 0 - 40°C, Humidity: 30-75% | NA | Similar (Discussion 2 states differences do not affect identical principles) |
| Operational modes (Handpiece) | Air-power | NA | Air-power | Identical to reference |
| Optical fiber (Handpiece) | WJ-15: without, WJ-15L: with light | NA | With light, without light | Identical to reference |
| Type of chuck (Handpiece) | Mechanical type chuck | NA | Mechanical type chuck | Identical to reference |
| Coupling dimensions (Handpiece) | Middle (ISO 3964-2016) | NA | ISO 3964 Standard Coupling | Identical to reference |
| Material of handpiece | Copper, Stainless steel | NA | Titanium | Different but justified not to affect principle of operation or new risk |
| Shanks for rotary instruments | Type3,Φ1.6mm drill ( ISO 1797-1-2011) | NA | Type 1, Type 3 | Identical to reference |
| Gear Ratio Max rotation speed (handpiece) | 1:5 Increasing- 200,000 min-1 | NA | 16:1, 10:1, 4:1 Reduction; 1:1 Direct; 1:5 Increasing | Identical to reference |
| Lubricant | NSK Pana-Spray (K052700) | NA | NSK PANA SPRAY Plus (K163483) | Identical to reference |
| Sterilization | Sterilized by user (Steam sterilization) | Sterilized by user (Steam sterilization) | Sterilized by user (Steam sterilization) | Identical to predicate/reference |
| Sterilization Validation Standard | ANSI/AAMI/ISO 17665-1:2006 | ANSI/AAMI/ISO 17665-1:2006 | ANSI/AAMI/ISO 17665-1:2006 | Identical to predicate/reference |
The "Remarks" column (e.g., "Identical," "Similar," "Different") from the original table serves as the performance outcome relative to the implied acceptance criterion of substantial equivalence. Where "Different" or "Similar" is noted, the document explicitly states in "Discussion 2" that these differences do not affect the identical principles of operation or cause new risks.
Non-clinical Tests Performed:
- Biocompatibility testing (ISO 10993-5, ISO 10993-10)
- Electric safety and EMC testing (IEC 60601-1, IEC 60601-1-2, IEC 80601-2-60)
- Bench testing (implied by the comparison and discussion of differences not affecting performance)
- Sterilization validation (ANSI/AAMI/ISO 17665-1:2006 and FDA Reprocessing Guidance)
- Software validation (per FDA Software Guidance for Moderate level of concern)
- Conformity to Dentistry-Handpieces and motors standard (ISO 14457: 2017)
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not applicable as the submission is for a traditional 510(k) for a mechanical dental device, not a diagnostic device or an AI/ML product typically requiring test sets of patient data. The "tests" mentioned are non-clinical engineering and bench tests, not clinical studies with patient samples. The manufacturer is Guilin Woodpecker Medical Instrument Co., Ltd. in China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. Ground truth experts are typically used for diagnostic or AI/ML device evaluations. This document details non-clinical testing against engineering standards and a comparison to predicate devices, not clinical ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are relevant for clinical trials or diagnostic studies, not for the non-clinical engineering tests performed for this 510(k).
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. This device is a dental electric motor, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. This device does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable in the clinical sense. For the non-clinical tests, the "ground truth" is defined by the requirements of the cited international and national standards (e.g., IEC, ISO, ANSI/AAMI), which specify test methods and acceptable performance limits for parameters like electrical safety, biocompatibility, and sterilization effectiveness.
8. The sample size for the training set
This information is not applicable. This device is a mechanical dental instrument, not an AI/ML system requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable. As above, no AI/ML system or training set is involved.
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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.
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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
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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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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 Summaryprepared | January 11, 2022 |
|---|---|
| Manufacturerinformation | Company title:Guilin Woodpecker Medical Instrument Co., Ltd. |
| Company address:Information Industrial Park, Guilin National High-Tech Zone, Guilin, Guangxi, 541004, ChinaContact person: Jiakang NingPhone: +86 7735873198Fax: +86-7735822450E-mail:zmnbg03@glwoodpecker.com | |
| SubmissionCorrespondent | Shenzhen Joyantech Consulting Co., Ltd.Address: 1713A, 17th Floor, Block A, |
| Image: [logo]卓远天成 | Zhongguan Times Square, Liuxian Avenue, XiliTown, Nanshan District, Shenzhen, GuangdongProvince, China.Contact person: Mr. Field FuE-Mail:field@cefda.com; |
| Establishmentregistration 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 |
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| 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.
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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 PredicateDevice(K163131) | Referencedevice(K182999) | Remarks |
|---|---|---|---|---|
| ProductCode | EBW, EGS | EBW | EGS | Identical |
| RegulationNo. | 872.4200 | 872.4200 | 872.4200 | Identical |
| Class | I | I | I | identical |
| Indicationfor use | The MT2 dental electricmotor consists of mainunit, motor, motor tail,power adapter andpower cord. It isintended for use ingeneral dentalapplications such as:cutting a tooth for cavitypreparation, crownpreparation, crownfinishing, inlay, filing,polishing, prophylaxisand endodontictreatment. The DentalElectric Motor can beused with ISO E-type astraight, right-angle or | The A-dec NLZelectric motorsystem is comprisedof a control unit thatdrives a directcurrent (DC) electricmicromotor that isactivated by meansof a foot control. It isintended for use ingeneral dentalapplications suchas: cutting a toothfor cavitypreparation. Crown | The GeneralCutting ContraHandpiece ispowered by eitheran air-motor orelectricmicromotor foruse in generaldentistry. Thedevice is intendedfor cutting andgrinding teeth,cavitypreparations,tooth and crown | Similar(Discussion1) |
| Item | Subject Device | Primary Predicate Device(K163131) | Reference device(K182999) | Remarks |
| contra-angle handpieceattachment of equal,gear-reducing, or gearincreasing speed.The contra-anglehandpieces (model:WJ-15, WJ-15L) are drivenby a micro-motor torotate at a specifiedspeed, so as to drivethe dental bur. It isapplicable to drillingand grinding in dentalsurgery. | preparation, crownfinishing, inlay,filing, polishing,prophylaxis andendodontictreatment, with useof a straight, right-angle or contra-angle ISO E-typehandpieceattachment of equal,gear-reducing, orgear-increasingspeed. | preparations,finishing andtrimming teethand fillingmaterials andremoval of crownsand fillingmaterials. | ||
| Dental electric Motor | ||||
| Drive | Electric-micromotor | Electric-micromotor | NA | Identical |
| Components | Main unit, DC adapter,DC cord, motor, motortail | Motor controller,Electric micromotor,Motor tubing | NA | Identical |
| Powersource | AC/DC Adapter:Power supplyinput:100-240Vac,50/60Hz, 2.5APower supply output:DC30V, 3.0A | --- | NA | --- |
| Size | Main unit:W165.5 x D129.7 xH77.6mmMotor:DΦ22 x H76.7mmMotor tail:Length: 1800mm | Motor controller:D78.5 x W148.0 xH43.0mmMotor:Length: 31mm,Diameter:Φ20.1(Front),Φ22.1(Rear)Motor tubing:Length:NLZ CDAS:1600mmNLZ CDAI: 2080mm | NA | Different(Discussion 2) |
| Material ofMotorexterior | Aluminum alloy | Titanium | NA | Different(Disc |
| Item | Subject Device | Primary PredicateDevice(K163131) | Referencedevice(K182999) | Remarks |
| Light | LED | LED | NA | Identical |
| RotationSpeed | 2,000-40,000 rpm | 1,000 - 40,000 rpm | NA | Similar(Discussion 2) |
| Rotationdirection | Forward and reverse | Forward andreverse | NA | Identical |
| Coolantmechanism | Coolant air | Coolant air | NA | Identical |
| AvailableHandpiecetype | E-type (ISO 3964) | E-type (ISO 3964) | NA | Identical |
| Usageenvironment | Temperature: 5-40°C,Humidity: 30-75% | Temperature: 0 -40°C, Humidity: 30-75% | NA | Similar(Discussion 2) |
| Handpiece | ||||
| Operationalmodes | Air-power | NA | Air-power | Identical |
| Opticalfiber | WJ-15: without lightWJ-15L: with light | NA | With light, withoutlight | Identical |
| Type ofchuck | Mechanical type chuck | NA | Mechanical typechuck | Identical |
| Couplingdimensions | Middle (ISO 3964-2016) | NA | ISO 3964 (ENISO3964) StandardCoupling | Identical |
| Material ofhandpiece | Copper, Stainless steel | NA | Titanium | Different(Discussion2) |
| Shanks forrotaryinstruments | Type3,Φ1.6mm drill( ISO 1797-1-2011) | NA | Type 1, Type 3 | Identical |
| Item | Subject Device | Primary PredicateDevice(K163131) | Referencedevice(K182999) | Remarks |
| Gear RatioMaxrotationspeed(handpiece) | 1:5 Increasing-200,000 min-1 | NA | 16:1 Reduction-2,500 min-110:1 Reduction-4,000 min-14:1 Reduction-10,000 min-11:1 Direct Drive-40,000 min-11:5 Increasing-200,000 min-1 | Identical |
| Lubricant | NSK Pana-Spray(K052700) | NA | NSK PANASPRAYPlus (K163483) | Identical |
| Sterilization | Sterilized by user(Steam sterilization) | Sterilized by user(Steam sterilization) | Sterilized by user(Steamsterilization) | Identical |
| SterilizationValidationStandard | ANSI/AAMI/ISO17665-1:2006 | ANSI/AAMI/ISO17665-1:2006 | ANSI/AAMI/ISO17665-1:2006 | Identical |
Comparison to predicate device:
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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
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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.
§ 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.