A-DEC/W&H ELECTRIC HANDPIECE MOTOR
Device Facts
| Record ID | K133776 |
|---|---|
| Device Name | A-DEC/W&H ELECTRIC HANDPIECE MOTOR |
| Applicant | A-Dec, Inc. |
| Product Code | EBW · Dental |
| Decision Date | May 28, 2014 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 872.4200 |
| Device Class | Class 1 |
| Attributes | Therapeutic |
Indications for Use
The A-dec/W&H Electric Motor kit is a device system comprised of a control unit that drives a DC electric micromotor that is activated by means of a footswitch. It is intended for use in general dental applications such as: cutting a tooth for cavity preperation, 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 gearincreasing speed.
Device Story
A-dec/W&H Electric Motor EA-53 is a dental control unit driving a DC brushless electric micromotor. System integrates into dental operatory chairs, powered by 24 VAC supply. Input is user-controlled via footswitch; motor provides near-constant torque for dental handpiece attachments (straight, right-angle, contra-angle). Device replaces air motors to prevent stalling during high-torque procedures. Output is rotational mechanical force for dental restoration, prophylaxis, and endodontic tasks. Operated by dental professionals in clinical settings. Software manages motor on/off, direction, speed, torque regulation, and LED lighting. Benefits include uniform dental reduction, improved lighting via LED, and ergonomic improvements over previous models.
Clinical Evidence
No clinical data. Bench testing only, including torque, direction, and stop-time studies. Validation included electromagnetic compatibility, electrical safety, thermal safety, photobiological safety, sterilization, and biocompatibility testing per consensus standards.
Technological Characteristics
System includes motor controller, DC brushless electric micromotor, and handpiece tubing with ISO-E coupler. Features LED lighting (solid-state). Software-controlled motor functions. Autoclavable micromotor. Integrated into dental chair power supply (24 VAC).
Indications for Use
Indicated for general dental applications including cavity preparation, crown preparation/finishing, inlay, filing, polishing, prophylaxis, and endodontic treatment. Used with ISO E-type handpiece attachments (straight, right-angle, or contra-angle) of varying speeds. No specific age or gender restrictions noted.
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/W&H Electric Motor, Model EA-50LT (K032572)
Submission Summary (Full Text)
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MAY 2 8 2014
Image /page/0/Picture/1 description: The image shows the logo and contact information for A-dec, a company specializing in reliable creative solutions. The logo features the company name in a stylized font, with a caduceus symbol incorporated into the 'a'. Below the logo, the text reads 'reliablecreativesolutions' followed by the address '2601 Crestview Drive, Newberg, Oregon 97132-9257, United States'. The phone number '503.538.9471' and website 'www.a-dec.com' are listed at the bottom.
K133776
# 510(k) Summary A-dec/W&H Electric Motor, Model EA-53 Date Summary Prepared: 01/14/2014
Submitter's Name and Address
A-dec, Inc. 2601 Crestview Drive Newberg, OR 97132 Phone: 503-538-9471 FAX: 503-537-2702
Contact Person
Bonnie Dundas Phone: 503-538-9471 ext. 2534 Email: bonnie.dundas@a-dec.com
Device Name
Trade or Proprietary Name: Common or Usual Name: Device Classification Name: Regulation Number: Device Class: Product Code:
A-dec/W&H Electric Motor, Model EA-53 Dental Handpiece Electric Motor Controller, Foot, Handpiece and Cord 872.4200 -EBW
Predicate Device
A-dec/W&H Electric Motor, Model EA-50LT (K032572)
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#### Device Description
The A-dec/W&H Electric Motel EA-53 is designed to accommodate existing and new Alegra, Proxeo, Endea, and Synea handpiece attachments for the purpose of performing dental restoration procedures. When equipped with the electric micromotor, the handpiece attachments provide the same effective drive force as would be provided by existing air motors. The significant advantage to driving a handpiece with the electric micromotor is the near-constant torque applied by the electric brushless micromotor. With air motor drive, the handpiece will tend to stall in extreme torque situations. The near-constant torque applied by the electric micromotor results in a more uniform and efficient dental reduction of the operatory site. The electric micromotor is autoclavable.
This 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 300W power supply secondary voltage output. The handpiece tubing extends from the control head to the ISO-E coupler. The micromotor is attached to the coupler on one end and attached on the other (output) end to a handpiece attachment suitable for the intended dental procedure. This system will include:
- Motor Controller .
- . Electric Micromotor
- Handpiece tubing with E-connector ●
#### Indications for Use
The A-dec/W&H Electric Motor kit is a device system comprised of a control unit that drives a DC electric micromotor that is activated by means of a footswitch. 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, right- angle, or contra-angle ISO E-type handpiece attachment of equal speed, gear-reduction speed, or gear-increasing speed.
#### Substantial Equivalence
The A-dec/W&H Electric Motor. Model EA-53 is substantially equivalent to the predicate device, the A-dec/W&H Electric Motor, Model EA-50LT in that it is a software driven dental control unit consisting of an AC motor and an integrated ISO coupler for connection to existing handpieces. As with the predicate device, it is integrated in a dental unit and uses the same water system and the same power supply. The software in the A-dec/W&H Electric Motor, Model EA-53 controls the following basic functions: motor on/off, motor direction, speed and torque regulation/limitation, led on/off, interaction with the control unit.
Changes from the predicate device EA-50LT (2003) to the new EA-53 (2013) are related to technological enhancements, such as a reduction in physical dimensional size, improved galvanic isolation, and improved user comfort due to lighter weight, improved lighting, and torque. The improved lighting for the A-dec/W&H EA-53 Electric Motor
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system resulted from changing to an LED bulb from the traditional halogen bulb used in the EA-50LT predicate device. This new LED bulb provides a low heat, solid state light that consumes less power, thereby lasting longer, than a traditional halogen lamp. The changes do not impact the safety or efficacy of the device and the fundamental scientific technology of the device remains the same.
#### Non-Clinical Test Data
Torque, direction and stop time studies have been conducted to determine the parameters of the device functions. The A-dec/W&H Electric Motor, Model EA-53 has been successfully validated to confirm the performance of the device. The validation included testing of electromagnetic compatibility, electrical safety, thermal safety and photobiological safety, which have been conducted in accordance with applicable recognized consensus standards. Also sterilization and biocompatibility studies were done to determine the safety and effectiveness of the A-dec/W&H Electric Motor, Model EA-53.
### Clinical Test Data
Clinical testing has not been conducted on these products.
#### Conclusions
Model EA-53 is deemed to be substantially equivalent to the predicate device, based upon similar technological/performance characteristics as compared to the predicate device and successful validation of the A-dec/W&H Electric Motor, Model EA-53.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 28, 2014
A-dec. Incorporated Ms. Bonnie Dundas Regulatory Audit Coordinator 2601 Crestview Drive Newberg, OR 97132
Re: K133776
Trade/Device Name: A-dec/W&H Electric Motor, Model EA-53 Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EBW Dated: May 1, 2014 Received: May 5, 2014
Dear Ms. Dundas:
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. 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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Page 2 - Ms. Dundas
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDeyices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
MaryStBunner-S
Erin I. Keith, M.S. 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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510(k) Number (if known):
K133776
Device Name:
A-dec/W&H Electric Motor EA-53
Indications For Use:
The A-dec/W&H Electric Motor kit is a device system comprised of a control unit that drives a DC electric micromotor that is activated by means of a footswitch. It is intended for use in general dental applications such as: cutting a tooth for cavity preperation, 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 gearincreasing speed.
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Concurrence of CDHR, Office of Device Evaluation (ODE)
Prescription Use × (Per 21 CFR 801.109)
And/Or Over-The-Counter Use (Optional Format 1-2-96)
> Sheena A. Gr 2014.05.28 08
