(90 days)
Not Found
No
The device description focuses on the electromechanical conversion of pneumatic signals to control an electric motor, with speed controlled by air pressure. There is no mention of AI, ML, or any data processing that would suggest such technologies are involved.
No
The device is a control unit that converts pneumatic output to drive dental handpieces; it does not directly treat a disease or condition.
No
The device's description and intended use clearly state it's for operating dental handpieces and converting pneumatic output, not for diagnosing medical conditions.
No
The device description explicitly lists hardware components such as a base unit, motor hose, electrical motor, transformer, and power cord, indicating it is not software-only.
Based on the provided information, the ELECTROmatic device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for converting pneumatic output to drive dental handpieces for operation on electrically-driven dental handpieces. This is a mechanical and electrical function related to dental procedures performed on a patient, not on a sample from a patient.
- Device Description: The description details a system for operating dental handpieces, involving power supply, air/water lines, and motor control. This aligns with a device used in a clinical setting for direct patient treatment.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), detecting substances, or providing diagnostic information based on in vitro testing.
In summary, the ELECTROmatic is a dental device used for powering and controlling dental handpieces during procedures, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The ELECTROmatic is intended to convert pneumatic output from a dental treatment center to drive the COMFORT drive motor handpiece and the INTRA LUX KL 703 LED motor for operation of electrically-driven dental handpieces. This device is designed for use by a trained professional in the field of general dentistry.
Product codes
EBW
Device Description
The ELECTROmatic dental control unit is a stand-alone system for operating electrically-driven KaVo handpieces. External power supply provides electric power to the unit. The 4-hole tubing connected to the unit supplies chip /cooling air, water and pressure signal. The speed of the electric handpiece is controlled by air pressure. The control unit is positioned close to a treatment unit at the location preferred by the dentist. The ELECTROmatic system consists of a base unit with a motor hose, an electrical motor, a transformer, and a power cord.
The ELECTROmatic is available in the following models:
- ELECTROmatic M/C (M-S, M-L, C-S, C-L): This model represents the basic model available with either the INTRA LUX KL 703 LED motor (M) or the COMFORTdrive (C). Both configurations can be equipped with a short tubing (S) or long tubing (L).
- ELECTROmatic PM/PC (PM-S, PM-L, PC-S, PC-L): This model represents the push button version (P) available with either the INTRA LUX KL 703 LED motor (M) or the COMFORTdrive (C). Both configurations can be equipped with a short tubing (S) or long tubing (L).
- ELECTROmatic TM (TM-S, TM-L): This model represents the touch display version (T) equipped with the INTRA LUX KL 703 LED motor (M). This configurations can be equipped with a short tubing (S) or long tubing (L).
- ELECTROmatic TMM/TMC (TMM-S, TMM-L, TMC-S, TMC-L): This model represents the touch display version (T) available with either two INTRA LUX KL 703 LED motors (MM) or one INTRA LUX KL 703 LED motor and one COMFORTdrive (MC). Both configurations can be equipped with a short tubing (S) or long tubing (L).
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
Trained professional in the field of general dentistry.
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 bench testing according to international standards has been conducted to determine conformance. Biocompatibility and sterilization studies has been completed for the applicable components. Hence the ELECTROmatic demonstrates substantial equivalence.
The performance of the ELECTROmatic has been verified utilizing the following standards:
- ISO 9168 2009-07-15 Dentistry Hose connectors for air driven dental handpieces
- ISO 14457 First edition 2012-09-15 - Dentistry - Handpieces and motors
- IEC 60601-1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007))
- IEC 60601-1-2 - Medical electrical equipment - Part 1-2: General requirements for safety: Collateral standard: Electromagnetic compatibility; Requirements and tests (IEC 60601-1-2:2007 / EN 60601-1-2:2007)
- ANSI/AAMI ES60601-1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (ANSI/AAMI ES60601-1: 2005 / A2:2010)
- IEC 62304 - Medical device software - Software life cycle processes (IEC 62304:2006 -First edition)
- ISO 7405 Second edition 2008-12-15 - Dentistry - Evaluation of biocompatibility of medical devices used in dentistry / ISO 10993-1 - 2009-10-00 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system
- ISO 10993-1 - 2009-10-00 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, representing the department's focus on health and human well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 21, 2017
Kaltenbach & Voigt GmbH Stefan Trampler Director Regulatory Affairs Bismarckring 39 88400 Biberach Germany
Re: K163317
Trade/Device Name: ELECTROmatic Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I Product Code: EBW Dated: November 22, 2016 Received: November 23, 2016
Dear Stefan Trampler:
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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 Industry and Consumer Education 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. 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 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 Industry and Consumer Education 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.
Michael J. Ryan -S
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) K163317
Device Name ELECTROmatic
Indications for Use (Describe)
The ELECTROmatic is intended to convert pneumatic output from a dental treatment center to drive the COMFORT drive motor handpiece and the INTRA LUX KL 703 LED motor for operation of electrically-driven dental handpieces. This device is designed for use by a trained professional in the field of general dentistry
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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FORM FDA 3881 (8/14)
3
Image /page/3/Picture/0 description: The image contains the logo for KaVo Dental Excellence. The logo features the letters "KaVo" in a stylized font, with the "K" and "V" connected. Below the logo, the words "KaVo. Dental Excellence." are written in a smaller font. The logo is in a blue color.
Section V - 510(k) Summary
Submitter:
Kaltenbach & Voigt GmbH Bismarckring 39 88400 Biberach Stefan Trampler - Contact Person 49 (7351) 56 3515 - Phone number +49 (7351) 56 7 3515 - Facsimile
Date Summary Prepared: Jan, 27th 2017
Device Name:
- Trade Name - ELECTROmatic
- . Common Name - Dental Handpiece and Accessories
- . Classification Name - Dental Handpiece and Accessories, per 21 CFR § 872.4200
- . Device Class - Class I
- . Product Code - EBW
Devices for Which Substantial Equivalence is claimed:
ELECTROtorque TLC 4893 with INTRAmatic KL 702 (K103027) marketed by Kaltenbach & Voigt GmbH.
- Trade Name ELECTROtorque TLC 4893 with INTRAmatic KL 702 ●
- . Common Name - Dental Handpiece and Accessories
- Classification Name Dental Handpiece and Accessories, per 21 CFR § 872.4200 ●
- . Device Class - Class I
- . Product Code - EBW
Device Description:
The ELECTROmatic dental control unit is a stand-alone system for operating electrically-driven KaVo handpieces. External power supply provides electric power to the unit. The 4-hole tubing connected to the unit supplies chip /cooling air, water and pressure signal. The speed of the electric handpiece is controlled by air pressure. The control unit is positioned close to a treatment unit at the location preferred by the dentist. The ELECTROmatic system consists of a base unit with a motor hose, an electrical motor, a transformer, and a power cord.
Per the Guidance for Industry and FDA Staff; Bundling Multiple Devices or Multiple Indications in a Sinqle Submission, dated June 22, 2007, Kaltenbach & Voigt GmbH is bundling the ELECTROmatic models listed below as the models do not differ significantly in purpose, design, materials, energy source, function or any other feature related to substantial equivalence. The device description and intended use are identical for all models listed below. The differences between the models and mounting configurations are cosmetic in nature such as size/shape of the device, length of the tubings, amount of motors, design of display, etc. All critical components within the ELECTROmatic are common.
4
The ELECTROmatic is available in the following models:
| ELECTROmatic M/C
(M-S, M-L, C-S, C-L) | This model represents the basic model available
with either the INTRA LUX KL 703 LED motor (M)
or the COMFORTdrive (C). Both configurations
can be equipped with a short tubing (S) or long
tubing (L). |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ELECTROmatic PM/PC
(PM-S, PM-L, PC-S, PC-L) | This model represents the push button version
(P) available with either the INTRA LUX KL 703
LED motor (M) or the COMFORTdrive (C). Both
configurations can be equipped with a short
tubing (S) or long tubing (L). |
| ELECTROmatic TM
(TM-S, TM-L) | This model represents the touch display version
(T) equipped with the INTRA LUX KL 703 LED
motor (M). This configurations can be equipped
with a short tubing (S) or long tubing (L). |
| ELECTROmatic TMM/TMC
(TMM-S, TMM-L, TMC-S, TMC-L) | This model represents the touch display version
(T) available with either two INTRA LUX KL 703
LED motors (MM) or one INTRA LUX KL 703 LED
motor and one COMFORTdrive (MC). Both
configurations can be equipped with a short
tubing (S) or long tubing (L). |
The various mounting configurations for the ELECTROmatic are illustrated within the instructions for use. The differences between the models are the ELECTROmatic TM and ELECTROmatic TMM are the premier level devices and ELECTROmatic M/C and PM/PC are the mid-level devices.
Accessories:
Optional accessories (devices) that are attached to the ELECTROmatic are part of this submission and have already been cleared by the FDA. These optional accessories (devices) can be attached to the ELECTROmatic as indicated in their respective 510(k) summary statements. They are also attached to the predicate device (ELECTROtroque TLC 4893 with INTRAmatic KL 702) marketed by Kaltenbach & Voigt GmbH. Below are the accessories of the ELECTROmatic:
| Accessory | Product Code | Comment |
|---|---|---|
| INTRA LUX KL 703 LED (motor) | EBW | FDA cleared under K103027 |
| COMFORTdrive (motor handpiece) | EIA | FDA cleared under K080677 |
Principle of Operation / Mechanism of Action:
The ELECTROmatic device is a software-driven device. The software controls the following features: (1) Motor control, (2) Motor start / stop behavior, (3) Motor speed, (4) Motor performance, (5) Measuring power consumption, (6) Monitoring power consumption, and (7) SAFEdrive. The SAFEdrive software feature monitors the power consumption of electrical hand pieces to reduce the probability or severity of overheating, thus minimizing the risk of burns to the patient. The user can navigate through the software menu via the control panel. The electrical low-voltage motor (INTRA LUX KL 703 LED) and the COMFORTdrive motor handpiece are connected onto the KaVo specific tubing of the ELECTROmatic. The speed of the motor / motor handpiece is controlled by air pressure of the dental treatment center. The converted pneumatic output signal (electrical energy) from a dental treatment center drives either the motor to operate
5
an electrically-driven dental handpiece or the COMFORTdrive motor handpiece. Electrically-driven dental handpieces, which conform to ISO 3964, can be attached on the motor.
Statement of Intended Use:
The ELECTROmatic is intended to convert pneumatic output from a dental treatment center to electrical energy to drive the COMFORTdrive motor handpiece and the INTRA LUX KL 703 LED motor for operation of electrically-driven dental handpieces. This device is designed for use by a trained professional in the field of general dentistry.
Substantial Equivalence:
The ELECTROmatic function in a manner similar to and is intended for the same use as the ELECTROtorque TLC 4893 with INTRAmatic KL 702 (K103027) marketed by Kaltenbach & Voigt GmbH. The ELECTROmatic is similar to the predicate device (K103027) in that it is a software driven dental control unit consisting of a base unit with a motor hose, an electrical motor, a transformer and a power cord. Both the ELECTROmatic and the ELECTROtorque TLC 4893 with INTRAmatic KL 702 (K103027) have a motor connection for dental handpieces which are equipped with a handpiece connection according to ISO 3964 (Dentistry - Coupling dimensions for handpiece connectors - ISO 3964:1982) and they are intended to be used by a trained professional in the field of general dentistry. The ELECTROmatic is substantially equivalent in design, technological characteristics, application and function to the predicate device (K103027). Both the ELECTROtorque TLC 4893 with INTRAmatic KL 702 (K103027) and the ELECTROmatic have the same principle of operation and the devices can be attached to a dental treatment unit using the same water and air system. The software in the ELECTROmatic as well as the software in the ELECTROtorque TLC 4893 with INTRAmatic KL 702 (K103027) control the following features: (1) Motor control, (2) Motor start / stop behavior, (3) Motor speed, (4) Motor performance, (5) Measuring power consumption, (6) Monitoring power consumption, and (7) SAFEdrive.
The ELECTROmatic differs from the ELECTROtorque TLC 4893 with INTRAmatic KL 702 (K103027) in that they have different technological characteristics (motor / motor tubings, user interface, display and media). These differences are shown in the table below (Summary of the Technological Characteristics). The ELECTROmatic can also be equipped with the COMFORTdrive motor handpiece and the motor tubings can be removed via a quick connector. A TFT / touch display can be selected for the ELECTROmatic. An integrated valve unit supports the two tubings models with media (air, spray air, spray water).
The performance tests demonstrate that the differences in technological characteristics do not raise different concerns reqarding substantial equivalence to the predicate device. Hence, the ELECTROmatic is substantial equivalent to the ELECTROtorque TLC 4893 with INTRAmatic KL 702 (K103027) marketed by Kaltenbach & Voigt GmbH.
In summary, the ELECTROmatic indications for use described in this submission is substantially equivalent to the ELECTROtorque TLC 4893 with INTRAmatic KL 702 cleared under K103027. It also satisfies all criteria of substantial equivalence and does not raise new concerns regarding substantial equivalence: (1) Indications for Use, (2) Technological Characteristics and (3) Performance Data. The new device does not introduce a fundamentally new scientific technology and the nonclinical tests demonstrate that the device is substantial equivalent.
6
Summary of the Technological Characteristics:
| Descriptive
Information | ELECTROtorque TLC 4893 with
INTRAmatic KL 702 (K103027) | ELECTROmatic |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The ELECTROtorque TLC 4893 is intended
to convert pneumatic output from a dental
treatment center to electrical energy to
drive the INTRAmatic KL 702 motor for
operation of electrically-driven dental
handpieces. They are designed for use by
a trained professional in the field
of
general dentistry | The ELECTROmatic is intended to convert
pneumatic output from a dental treatment
center to electrical energy to drive the
COMFORTdrive motor handpiece and the
INTRA LUX KL 703 LED motor for operation
of electrically-driven dental handpieces.
This device is designed for use by a trained
professional in the field of general
dentistry |
| Device
Components | Control unit with hose and electrical
motor | Control unit with hose and electrical
motor |
| Installation | Attached to a dental treatment center | Attached to a dental treatment center |
| Power and Utility
Supply | 120V/230V AC electrical supply,
compressed air and water provided from
unit | 120V/230V AC electrical supply,
compressed air and water provided from
unit |
| Compatibility | Compatible with industry standard dental
hose connector for turbines | Compatible with industry standard dental
hose connector for turbines |
| User Interface | Membrane keys | Foot switch, touch keys / screen |
| Display | Dot matrix display | TFT / touch display |
| Compatible
Motors | INTRAmatic KL 702 | INTRA LUX KL 703 LED
COMFORTdrive |
| Motor Tubings | Fixed to the unit | Quick connector, removable |
| Water System | Water is supplied from unit | Water is supplied from unit |
| Media (air, spray
air, spray water) | Single hose connections | Integrated valve unit |
| Cleaning System | Cleaning System is supplied from unit | Cleaning System is supplied from unit |
| Software | Main part of the software is the KaVo
motor control algorithm, which is
controlling:
- Motor control
- Motor start / stop behavior
- Motor speed
- Motor performance
Measuring power consumption - Monitoring power consumption
(SAFEdrive function) | Main part of the software is the KaVo
motor control algorithm, which is
controlling: - Motor control
- Motor start / stop behavior
- Motor speed
- Motor performance
- Measuring power consumption
- Monitoring power consumption
(SAFEdrive function) |
| Intended Users | Dentists, Dental Hygienists | Dentists, Dental Hygienists |
7
Non-Clinical Test Data:
Performance bench testing according to international standards has been conducted to determine conformance. Biocompatibility and sterilization studies has been completed for the applicable components. Hence the ELECTROmatic demonstrates substantial equivalence.
The performance of the ELECTROmatic has been verified utilizing the following standards:
- ISO 9168 2009-07-15 Dentistry Hose connectors for air driven dental handpieces -
- -ISO 14457 First edition 2012-09-15 - Dentistry - Handpieces and motors
- -IEC 60601-1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007))
- -IEC 60601-1-2 - Medical electrical equipment - Part 1-2: General requirements for safety: Collateral standard: Electromagnetic compatibility; Requirements and tests (IEC 60601-1-2:2007 / EN 60601-1-2:2007)
- -ANSI/AAMI ES60601-1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (ANSI/AAMI ES60601-1: 2005 / A2:2010)
- -IEC 62304 - Medical device software - Software life cycle processes (IEC 62304:2006 -First edition)
- -ISO 7405 Second edition 2008-12-15 - Dentistry - Evaluation of biocompatibility of medical devices used in dentistry / ISO 10993-1 - 2009-10-00 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system
- -ISO 10993-1 - 2009-10-00 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system
Clinical Test Data:
Clinical data is not needed to characterize performance and establish substantial equivalence. The non-clinical test data characterize all performance aspects of the device based on wellestablished scientific and engineering principles. Clinical testing has not been conducted on this product.
Conclusion:
Based on a comparison of intended use, indications, technological characteristics, principle of operation, features and performance data, the ELECTROmatic is deemed to be substantially equivalent to the predicate device.