(178 days)
No
The device description focuses on traditional dental unit functions (air, water, electric energy) and mechanical controls. There is no mention of AI/ML terms, image processing, or data-driven performance metrics.
Yes.
The device description explicitly states it is "an active therapeutic device intended to administer or exchange energy...for diagnoses, treatments and relative procedures of dentistry."
Yes
The "Device Description" explicitly states that the product is "intended to administer or exchange energy of electric, air and water for the exclusive use for diagnoses, treatments and relative procedures of dentistry". The mention of "diagnoses" confirms its role as a diagnostic device.
No
The device description clearly outlines a physical dental unit that administers energy (electric, air, water) and has components like air unit systems, foot controls, and handpieces. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "traditional and normal patient treatment procedures in the dental operatory." This describes a device used directly on a patient for treatment, not for testing samples taken from the body.
- Device Description: The description details a device that administers or exchanges energy (electric, air, water) for dental diagnoses, treatments, and procedures. It mentions driving air motors, air scalers, and potentially electric scalers and micro motors. These are all tools used for direct patient care in dentistry.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform such functions.
The device described is a dental unit, which is a therapeutic and diagnostic device used in a dental operatory for direct patient care.
N/A
Intended Use / Indications for Use
Evogue Dental Unit series are intended for the Dentists, and Dental assistants for traditional and normal patient treatment procedures in the dental operatory.
Product codes
EIA
Device Description
This product is an active therapeutic device intended to administer or exchange energy of electric, air and water for the exclusive use for diagnoses, treatments and relative procedures of dentistry, and its characteristic is not in a potentially hazardous way between such energy and human body, taking account of the nature, the density and site of application of the energy.
The product must be operated or handled by the qualified dentists or by dental staffs under the supervision of the dentist.
Such dentists or dental staffs should instruct and/or assist the patients to approach to and leave from the product.
Patients should not be allowed to operate or handle the product unless he/she is so instructed.
The air unit system uses compressed air to drive air motor and air scaler. The new Evogue Dental Unit is air unit system. The function and components used for Evogue Dental Unit are very similar to X-Calibur unit (Belmont Model 2000 Series, K000799). Though the Evogue Dental Unit is typical air system, it does have upgrade ability to use micro motor with external touch pad (MX2 Optima) and integrated type electric scaler (Cavitron).
The foot control regulates drive air to the active handpiece to control the rotation speed of turbine and air motor. Also controls the frequency of air scaler.
It provides an air signal that activates air coolant and water coolant flow. The foot control is equipped with a wet/dry toggle to turn the water coolant on or off.
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
Dentists, and Dental assistants for traditional and normal patient treatment procedures in the dental operatory.
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)
Not Found
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
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.
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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 stylized depiction of a human face in profile, with three overlapping profiles suggesting a sense of community or interconnectedness. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the face, indicating the department's name and national affiliation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 22, 2016
Takara Belmont Corporation c/o Dr. Robert Schiff President 1120 Bloomfield Avenue, Suite 103 West Caldwell, New Jersey 07006
Re: K152100
Trade/Device Name: Evogue Dental Unit Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: December 11, 2015 Received: December 15, 2015
Dear Dr. Schiff:
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.
1
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 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/Resourcesfor You/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/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 vours.
Tina
Kiang -S
for Erin I. Keith, M.S. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known)
To be assigned K152100
Device Name
BELMONT, Evogue Dental Unit series
Indications for Use (Describe)
Evogue Dental Unit series are intended for the Dentists, and Dental assistants for traditional and normal patient treatment procedures in the dental operatory.
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)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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510(k) Summarv (as required by 807.92)
(1) SUBMITTER: Takara Belmont Corporation, LTD. Address: 1-1-2 Chome, Higashi-Shinsaibashi, Chuo-ku Telephone: 81-6-6213-5945 Contact person: Toshinori Kiyomatsu Date prepared: July 2015
- (2) DEVICE NAME: Unit, Operative Dental Trade Name: Evoque Dental Unit Common Name: Dental Unit Classification Name: Unit, Operative Dental Regulation Number: 872.6640
- (3) PREDICATE DEVICE: Substantial equivalence is based on following legally marketed
K000799 Belmont Unit, Model 2000 Series (Approved 05/17/2000)
- (4) DESCRIPTION OF THE DEVICE: This product is an active therapeutic device intended to administer or exchange energy of electric, air and water for the exclusive use for diagnoses, treatments and relative procedures of dentistry, and its characteristic is not in a potentially hazardous way between such energy and human body, taking account of the nature, the density and site of application of the energy.
The product must be operated or handled by the qualified dentists or by dental staffs under the supervision of the dentist.
Such dentists or dental staffs should instruct and/or assist the patients to approach to and leave from the product.
Patients should not be allowed to operate or handle the product unless he/she is so instructed.
The air unit system uses compressed air to drive air motor and air scaler. The new Evogue Dental Unit is air unit system. The function and components used for Evogue Dental Unit are very similar to X-Calibur unit (Belmont Model 2000 Series, K000799). Though the Evogue Dental Unit is typical air system, it does have upgrade ability to use micro motor with external touch pad (MX2 Optima) and integrated type electric scaler (Cavitron).
The foot control regulates drive air to the active handpiece to control the rotation speed of turbine and air motor. Also controls the frequency of air scaler.
It provides an air signal that activates air coolant and water coolant flow. The foot control is equipped with a wet/dry toggle to turn the water coolant on or off.
- (5) INTENDED USE: Evogue Dental Unit series are intended for the Dentists, Hygienists, and Dental assistants for traditional and normal patient treatment procedures in the dental operatory.
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510(k) Premarket Notification for Evogue Dental Unit Takara Belmont Corporation, Ltd.
(6) COMPARISON WITH PREDICATE DEVICES: Following table is a comparison of our new Evogue Dental Unit and predicate device Belmont Unit, Model 2000 Series.
| Evogue Dental Unit (New model) | Belmont Model 2000 Series Dental Unit &
Accessories (X-Calibur Unit) |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applying | K000799 |
| Chair, Cabinet Mounting | Chair, Cabinet & Cart Mounting |
| IFU Statement: Evogue Dental Unit series are
intended for the Dentists, Hygienists, and Dental
assistants for traditional and normal patient
treatment procedures in the dental operatory.*** | IFU Statement: Evogue Dental Unit series are
intended for the Dentists, Hygienists, and Dental
assistants for traditional and normal patient
treatment procedures in the dental operatory.
The design function, and positioning of the unit
and accessories are similar to most all other
dental units manufactured for this specific
purpose over the past twenty years |
| ***PLEASE NOTE that the IFU's are similar in how they are used for traditional patient dental
treatment; however, the IFU's for the predicate device provides a more descriptive comparison
to other traditional dental units. This detail does not affect the intended use of the device. | |
| Autoclavbable H.V.E. & Saliva Ejectors are
standard | Autoclavbable H.V.E. & Saliva Ejectors are
standard |
| Foot Control is standard | Foot Control is standard |
| Utility Box with manual air & water shut-off
valves, pilot operated shut-off valves, regulators,
gages, and air & water filters | Utility Box with manual air & water shut-off
valves, pilot operated shut-off valves, regulators,
gages, and air & water filters |
| Three cutting handpieces and automatic
controls are standard, up to five handpieces are
optional | Three cutting handpieces and automatic
controls are standard, up to four handpieces are
optional |
| Non-retracting water system for handpieces and
syringes standard | Non-retracting water system for handpieces and
syringes standard |
| 3-way syringe with quick disconnect tip and
autoclavable tips standard. Asepsis tubing
standard | 3-way syringe with quick disconnect tip and
autoclavable tips standard. Asepsis tubing
standard |
| Aseptic baggable type instrument holders
standard | Aseptic baggable type instrument holders
standard |
| Cuspidor with cup filler is standard. Gravity drain | Cuspidor with cup filler is standard. Gravity drain |
| H.V.E. & Saliva ejector asepsis tubing with
autoclavable instrument holders, standard with
brake-away safety feature | H.V.E. & Saliva ejector asepsis tubing with
autoclavable instrument holders, standard with
brake-away safety feature |
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(7) PERFORMANCE STANDARDS APPLIED:
- IEC 60601-1-2, IEC 60601-1-2 Edition 3: 2007-03, medical electrical equipment part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests.
- ISO 7405 (Dentistry Evaluation of biocompatibility of medical devices used in dentistry, Second Edition 12/15/08),
- ISO 7405:2008 specifies test methods for the evaluation of biological effects of medical devices used in dentistry. It includes testing of pharmacological agents that are an integral part of the device under test.
- ISO 7405:2008 does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body.
- ISO 7494-1 (Dentistry Dental units Part 1: General requirements and test methods, Second Edition 8/15/11)
- This part of ISO 7494 specifies requirements and test methods for dental units, regardless of whether or not they are electrically powered.
- It also specifies requirements for the manufacturer's instructions, marking and packaging.
ISO 7494-2 (Dentistry - Dental units - Part 2: Water and air supply, First Edition 03/01/2003)
- This part of ISO 7494 specifies requirements and test methods for materials, design and construction of the water and air supply within dental units in order to ensure that compressed water and air supplied via the dental unit are of appropriate quality. It includes provisions for the prevention of retraction of oral fluids into the water supply f the dental unit.
- This part of ISO 7494 does not address prevention of contamination and/or proliferation of hazardous micro-organisms (for example bacteria, viruses) in the dental unit.
- ISO 9168 (Dentistry Hose connectors for air driven dental handpieces, Third Version 07/15/2009)
- ISO 9168:2009 is applicable for achieving reliable interchangeability between hoses from dental units and dental handpieces.
- ISO 9168:2009 specifies four types of hose connector for use between air driven dental handpieces and the flexible hoses of the dental unit which supply the handpieces with water, air and light, and provide for exhaust.
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- ISO 14457 (Dentistry Handpieces and motors, First Edition 09/15/2012)
- ISO 14457:2012 is applicable to handpieces and motors used in dentistry for patient contact, regardless of their construction. It specifies requirements, test methods, manufacturer's information, marking and packaging.
- ISO 14457:2012 is applicable to:
-
- straight and geared angle handpieces, including handpiece attachments;
-
- high-speed air turbine handpieces;
-
- air motors
-
- electrical motors
-
- prophy handpieces
- (8) CONCLUSION: The Evogue Dental Unit has the same intended use and technology characteristics as the predicate device Belmont Unit, Model 2000 Series. The proposed device is substantially equivalent to the noted predicate.