Electric Handpiece Motor EM-12 L is a brushless DC electric micromotor controlled by a control unit. The electrical drive, EM-12 L is indicated for use in the field of preventive applications including cavity preparation and endodontic therapy, prosthodontics applications such as crown preparations.

Device Description

The W&H electric motor EM-12 L is designed to accommodate existing and new handpiece attachments (already cleared for market under K070663 and K162926) for the purpose of performing dental procedures as described above. The advantage to driving a handpiece with this electro motor is the adjustable speed and near-constant torque applied by the electric brushless micro motor. The system will be used in an integrated configuration on the dental operatory chair system. The motor controller is contained within the control head (Dental unit) and acquires +24 VAC from the chair system 300 W power supply secondary voltage output. The motor tubing extends from the motor controller inside the control head to the micro-motor with ISO-E-coupler suitable to a handpiece attachment for the intended dental procedure. The Electric Handpiece Motor is to be installed in A-dec dental operative units. The power/CAN-Bus will be provided by the dental unit controller board and connected to the controller.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the "Electric Handpiece Motor EM-12 L". It focuses on establishing substantial equivalence to a predicate device and details non-clinical testing. It explicitly states that clinical performance testing was NOT conducted. Therefore, there is no study described that proves the device meets acceptance criteria related to clinical performance. The acceptance criteria and "device performance" in this context refer to the successful completion of non-clinical tests and the device's adherence to relevant standards, not clinical efficacy or diagnostic accuracy.

Here's the breakdown of the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Standard / Test)	Reported Device Performance (Compliance)
Electrical Safety	IEC 60601-1:2005+A1:2012 (3.1 Edition)	Compliant
Electromagnetic Compatibility (EMC)	IEC 60601-1-1:2007	Compliant
Product Function & Life Cycle	ISO 14457:2012 (Dentistry – Handpieces and Motors)	Compliant
Motor Cooling Air, Spray Air & Water Supply	ISO 14457:2012	Compliant
Temperature Testing	ISO 14457:2012	Compliant
Reprocessing Validation	FDA Guidance for Reprocessing of Medical Devices in Health Care Setting (March 17, 2015)	Compliant
Software Documentation	FDA Guidance Document for Software Contained in Medical Devices (May 11, 2005) (Moderate Level of Concern)	Compliant
Software Validation	IEC 62304:2006 (Medical device software)	Compliant
Thermal Safety	IEC 62471:2006 (Photobiological safety)	Compliant
Biocompatibility	ISO 10993	Compliant (meets requirements)

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not explicitly stated for each non-clinical test. The testing was performed on the device itself and its components.
Data Provenance: The tests were conducted internally by the manufacturer (W&H Dentalwerk Bürmoos GmbH) or by accredited labs on their behalf, adhering to international and FDA standards. The country of origin is Austria (manufacturer location). This is retrospective data regarding the device's design and manufacturing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The ground truth for these non-clinical tests is established by the specified international standards (e.g., IEC 60601, ISO 14457, ISO 10993) and FDA guidance documents. Compliance with these standards indicates the "ground truth" of safety and performance for this type of device in a regulatory context. There are no "experts" in the sense of clinical reviewers establishing ground truth for individual cases.

4. Adjudication method for the test set

Not applicable for non-clinical engineering and safety tests. The "adjudication" is whether the device's performance characteristics (e.g., electrical safety, EMC emissions, torque, temperature) meet the predefined limits and requirements set forth in the relevant standards.

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

No. This is a dental handpiece motor, not an AI or imaging device that would involve human readers or MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

No. This is a physical medical device (dental handpiece motor), not an algorithm. Performance assessment is based on physical and electrical characteristics against predefined engineering and safety standards.

7. The type of ground truth used

The ground truth used for these non-clinical tests is compliance with established international and national standards, regulations, and validated test methodologies. For example, for Electrical Safety, the ground truth is defined by IEC 60601-1. For biocompatibility, it's ISO 10993.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device that requires a training set.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services - USA logo, which features a stylized human figure. To the right is the FDA U.S. Food & Drug Administration logo, with the FDA acronym in a blue square and the full name in blue text.

March 26, 2019

W&H Dentalwerk Buermoos GmbH Anja Lindner Regulatory Affairs Specialist Ignaz-Glaser-Straße 53 Burmoos, Salzburg 5111 AUSTRIA

Re: K181858

Trade/Device Name: Electric Handpiece Motor EM-12 L Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: Class I Product Code: EBW Dated: December 21, 2018 Received: December 26, 2018

Dear Anja Lindner:

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 mav, 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 avare 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.

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Mary S. Runner -S3 P.

For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K181858

Device Name Electric Handpiece Motor EM-12 L

Indications for Use (Describe)

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)

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Image /page/3/Picture/0 description: The image shows a logo with the letters "W&H" inside a gray, horizontally-oriented octagon. Above the logo is a green banner with the text "PEOPLE HAVE PRIORITY" in white letters. The logo and banner are centered in the image.

200000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 K181858

Submitter	W & H DENTALWERK BÜRMOOS GMBHIgnaz-Glaser-Strasse 53A - 5111 BürmoosAustriaTel.: 0043 -6274 / 6236 -397Fax: 0043 -6274 / 6236 -55
Registration Number	9681479
Contact Person	Mag. Anja LINDNER
Date of Preparation	March 25, 2019
Device Name	Electric Handpiece Motor EM-12L
Classification Name	Dental Handpiece and Accessories
Regulation Number	21 CFR 872.4200
Regulatory class	I
Product Code	EBW
Predicate Devices	Predicate device for the electric motor EM-12 L:"Electric Handpiece Motor", A-dec/W&H cleared underK133776
Device Description	The W&H electric motor EM-12 L is designed toaccommodate existing and new handpiece attachments(already cleared for market under K070663 and K162926)for the purpose of performing dental procedures asdescribed above. The advantage to driving a handpiecewith this electro motor is the adjustable speed and near-constant torque applied by the electric brushless micromotor.The system will be used in an integrated configuration on thedental operatory chair system. The motor controller iscontained within the control head (Dental unit) and acquires+24 VAC from the chair system 300 W power supplysecondary voltage output. The motor tubing extends fromthe motor controller inside the control head to the micro-motor with ISO-E-coupler suitable to a handpieceattachment for the intended dental procedure.The Electric Handpiece Motor is to be installed in A-decdental operative units.The power/CAN-Bus will be provided by the dental unitcontroller board and connected to the controller.

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Electric Handpiece Motor EM-12 L510(k) Summary			Item	New device	Predicate device	Judgement
The dental unit controller board, display, foot control and active handpiece switch are part of the system manufacturer dental unit and not a W&H part.The motor will be directly connected to the motor controller by the system manufacturer (not W&H).The system manufacturer gets an installation manual for the motor controller and the motor.			Name	W&H Electric Motor EM-12L	A-Dec Electric Motor EA-53	---
Indications for Use:	Electric Handpiece Motor EM-12 L is a brushless DC electric micromotor controlled by a control unit.The electrical drive, EM-12 L is indicated for use in the field of preventive dentistry, restorative applications including cavity preparation and endodontic therapy, prosthodontics applications such as crown preparations.		Photo	Image: W&H Electric Motor EM-12L	Image: A-Dec Electric Motor EA-53	---
TechnologicalCharacteristics	Item	New deviceEM-12 L	Predicate deviceEA-53	Judgment	Where used	Dental practice, dental clinic.	Dental practice, dental clinic.	same
	Powersupply	100 – 240 V AC	100 – 240 V AC	Same	Manufacturer	W&H Dentalwerk Bürmoos GmbHwww.wh.com	A-dec	---
	Speedrange	100 to 40,000 rpm	100 to 40,000 rpm	Same	510(k)	Submitted K181858	K133776submitted A-dec, Inc.	---
	Supplyconnection	ISO 9168	ISO 9168	Same	Indication for Use	Electric Handpiece Motor EM-12 L is a device system comprised of a control unit that drives a DC electric micromotor. The electrical drive, EM-12L is indicated for use in the field of preventive dentistry, restorative applications including cavity preparation and endodontic therapy, prosthodontics applications such as crown preparations.	The A-dec/W&H Electric Motor Kit 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, right-angle, or contra-angle ISO E-type handpiece attachment of equal speed, gear-reduction speed, or gear-increasing speed.	Similar
	Airpressure	3 ± 0.3 bar	3 ± 0.3 bar	Same	Enclosure	New DeviceMC-1.0 / MC-2.0 EMaximum Size	Predicate DeviceCM-1.1 / CM-2.1Maximum Size	Same
	Waterpressure	0.5 to 3 bar	0.5 to 3 bar	Same	Length	142 mm	138 mm	Similar
	Chip Airpressure	0.5 to 3 bar	0.5 to 3 bar	Same	Width	60 mm	60 mm	Same
	Motortorque	3 Ncm	3 Ncm	Same	Height	43 mm	43 mm	Same
	Light	yes	yes	Same	Material	Flame-rated plastic	same	Same
The technical principle is the same as within the predicate device.The main differences between the subject and the predicate device are the different labeling especially the name designation and the reciproc®/wave one® function, which do not raise any additional question regarding substantial					Installation	By qualified and authorized personnel	same	Same
Digital Interface
Protocol	CAN	CAN	Same

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PEOPLE HAVE PRIORITY
Image: W&H logo

	material are the same or, at least, quite similar to those of thepredicate device.
Non-clinical testing	Electrical Safety Tests according to IEC 60601-1:2005+A1:2012 (3.1 Edition), Medical electrical equipment– Part 1: General requirements for basic safety andessential performance.
	Electromagnetic Compatibility Test according to IEC 60601-1-1:2007: General requirement for basic safety and essentialperformance - Collateral standard: Electromagneticcompatibility – Requirements and tests
	Product testing of the Electric Handpiece Motor's function andlife cycle testing were performed according to ISO14457:2012: Dentistry – Handpieces and Motors.Motor cooling air, spray air supply and water supply was testedaccording to ISO 14457:2012Various temperature testing was also performed according toISO 14457:2012
	Reprocessing validation per the FDA Guidance forReprocessing of Medical Devices in Health Care Settingissued on March 17, 2015
	Software Documentation of Moderate Level of Concern perthe FDA Guidance Document for Software Contained inMedical Devices issued on May 11, 2005
	Software validation according to IEC 62304:2006: Medicaldevice software – Part 1: Guidance on the application of ISO14972 to medical device software
	Thermal safety according to the standard IEC 62471:2006:Photobiological safety of lamps and lamp systems
	Evaluation of biocompatibility is based on ISO 10993. Theevaluation meets the requirements.

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Electric Handpiece Motor EM-12 L510(k) Summary
Clinical Testing	Clinical performance testing was not conducted.
Conclusion	W&H considers the Electric Handpiece Motor EM-12 L to besubstantially equivalent to the predicate device listed above. Thisconclusion is based on the similarities in intended use, principles ofoperation, functional design, and establishment medical use.Differences between the devices shown in the comparison sectionabove are minor and do not have any negative effect on equivalence.

Regulation Number and Section

§ 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.