(257 days)
No
The description focuses on the electromechanical aspects of the device (brushless DC motor, adjustable speed, constant torque) and its integration with existing dental equipment. There is no mention of AI, ML, or any data processing that would suggest such capabilities.
Yes
The device is indicated for use in preventive applications, cavity preparation, endodontic therapy, and prosthodontics applications, which are all therapeutic dental procedures.
No
The device description clearly states its purpose is for "performing dental procedures" such as "cavity preparation and endodontic therapy, prosthodontics applications such as crown preparations," and operating handpiece attachments. These are all therapeutic and preparatory procedures, not diagnostic ones.
No
The device description clearly outlines hardware components including a brushless DC electric micromotor, a control unit, motor tubing, and an ISO-E-coupler. While software is mentioned for validation, the core device is a physical motor system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes procedures performed on a patient (cavity preparation, endodontic therapy, crown preparations). IVD devices are used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a motor and handpiece system used for mechanical procedures in dentistry. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD-specific information: The document does not contain any information typically associated with IVD devices, such as:
- Analysis of biological specimens.
- Reagents or assays.
- Diagnostic claims based on sample analysis.
Therefore, the Electric Handpiece Motor EM-12 L is a medical device used for dental procedures, not an in vitro diagnostic device.
N/A
Intended Use / 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 applications including cavity preparation and endodontic therapy, prosthodontics applications such as crown preparations.
Product codes
EBW
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.
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
Where used: Dental practice, dental clinic.
Installation: By qualified and authorized personnel
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)
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 and essential performance.
Electromagnetic Compatibility Test according to IEC 60601-1-1:2007: General requirement for basic safety and essential performance - Collateral standard: Electromagnetic compatibility – Requirements and tests
Product testing of the Electric Handpiece Motor's function and life cycle testing were performed according to ISO 14457:2012: Dentistry – Handpieces and Motors.
Motor cooling air, spray air supply and water supply was tested according to ISO 14457:2012
Various temperature testing was also performed according to ISO 14457:2012
Reprocessing validation per the FDA Guidance for Reprocessing of Medical Devices in Health Care Setting issued on March 17, 2015
Software Documentation of Moderate Level of Concern per the FDA Guidance Document for Software Contained in Medical Devices issued on May 11, 2005
Software validation according to IEC 62304:2006: Medical device software – Part 1: Guidance on the application of ISO 14972 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. The evaluation meets the requirements.
Clinical Testing: Clinical performance testing was not conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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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
1
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
2
Indications for Use
510(k) Number (if known) K181858
Device Name Electric Handpiece Motor EM-12 L
Indications for Use (Describe)
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.
| 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 GMBH
Ignaz-Glaser-Strasse 53
A - 5111 Bürmoos
Austria
Tel.: 0043 -6274 / 6236 -397
Fax: 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 under
K133776 |
| 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. |
4
| Electric Handpiece Motor EM-12 L
| 510(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 | --- | | |
| Technological
Characteristics | Item | New device
EM-12 L | Predicate device
EA-53 | Judgment | Where used | Dental practice, dental clinic. | Dental practice, dental clinic. | same |
| | Power
supply | 100 – 240 V AC | 100 – 240 V AC | Same | Manufacturer | W&H Dentalwerk Bürmoos GmbH
www.wh.com | A-dec | --- |
| | Speed
range | 100 to 40,000 rpm | 100 to 40,000 rpm | Same | 510(k) | Submitted K181858 | K133776
submitted A-dec, Inc. | --- |
| | Supply
connection | 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 |
| | Air
pressure | 3 ± 0.3 bar | 3 ± 0.3 bar | Same | Enclosure | New Device
MC-1.0 / MC-2.0 E
Maximum Size | Predicate Device
CM-1.1 / CM-2.1
Maximum Size | Same |
| | Water
pressure | 0.5 to 3 bar | 0.5 to 3 bar | Same | Length | 142 mm | 138 mm | Similar |
| | Chip Air
pressure | 0.5 to 3 bar | 0.5 to 3 bar | Same | Width | 60 mm | 60 mm | Same |
| | Motor
torque | 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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6
| PEOPLE HAVE PRIORITY |
|---|
| Image: W&H logo |
| | material are the same or, at least, quite similar to those of the
predicate 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 and
essential performance. |
| | Electromagnetic Compatibility Test according to IEC 60601-
1-1:2007: General requirement for basic safety and essential
performance - Collateral standard: Electromagnetic
compatibility – Requirements and tests |
| | Product testing of the Electric Handpiece Motor's function and
life cycle testing were performed according to ISO
14457:2012: Dentistry – Handpieces and Motors.
Motor cooling air, spray air supply and water supply was tested
according to ISO 14457:2012
Various temperature testing was also performed according to
ISO 14457:2012 |
| | Reprocessing validation per the FDA Guidance for
Reprocessing of Medical Devices in Health Care Setting
issued on March 17, 2015 |
| | Software Documentation of Moderate Level of Concern per
the FDA Guidance Document for Software Contained in
Medical Devices issued on May 11, 2005 |
| | Software validation according to IEC 62304:2006: Medical
device software – Part 1: Guidance on the application of ISO
14972 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. The
evaluation meets the requirements. |
7
| Electric Handpiece Motor EM-12 L
| 510(k) Summary | |
|---|---|
| Clinical Testing | Clinical performance testing was not conducted. |
| Conclusion | W&H considers the Electric Handpiece Motor EM-12 L to be |
| substantially equivalent to the predicate device listed above. This | |
| conclusion is based on the similarities in intended use, principles of | |
| operation, functional design, and establishment medical use. | |
| Differences between the devices shown in the comparison section | |
| above are minor and do not have any negative effect on equivalence. |