TENEO Dental Treatment Unit and Accessories

K151045 · Sirona Dental Systems GmbH · EIA · Jul 24, 2015 · Dental

Device Facts

• Record ID: K151045
• Device Name: TENEO Dental Treatment Unit and Accessories
• Applicant: Sirona Dental Systems GmbH
• Product Code: EIA · Dental
• Decision Date: Jul 24, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The dental treatment unit with accessories is intended to supply power to and serve as a base for dental devices and accessories. This product includes a dental chair. The dental treatment unit is intended for use in the dental clinic environment and is used by trained dentists and/or dental assistants. The motors serve as drives for rotating and oscillating straight and contra-angle hand pieces in connection with a dental treatment unit. They are used for endodontic and general dental purposes. The SPRAYVIT M multifunctional syringe is used for dental treatment with unheated air and heated water. It is also used to illuminate the preparation field.

Device Story

TENEO is a dental operating system comprising a patient chair, foot control, dentist/assistant elements, and water unit. It serves as a base for dental instruments (handpieces, motors, curing lights, scalers). Inputs include user-defined parameters (torque, speed, power) via touch panel or foot control; electrical impedance signals for ApexLocator function. The device transforms inputs into mechanical chair positioning, motor-driven instrument operation, and fluid/suction management. It provides an integrated therapy package for endodontics and implantology, featuring electronic torque limitation and file library. The ApexLocator uses mucosal electrodes to estimate root canal file position, providing acoustic/visual feedback. The system includes automated infection control (waterline sanitization, suction hose cleaning). Used in dental clinics by dentists/assistants; output (chair position, instrument activation, endodontic measurements) assists in clinical decision-making and procedural efficiency. Benefits include ergonomic patient positioning, integrated procedural control, and automated maintenance of hygiene standards.

Clinical Evidence

Bench testing only. Clinical assessment conducted via critical analysis of the benefit-risk ratio by a dental practitioner. Compliance with performance standards including ISO 7494-1/2, ISO 10993-1/5/10, IEC 60601-1, IEC 62304, and ISO 14971. Sterilization and biocompatibility testing provided.

Technological Characteristics

Dental operative unit with motorized patient chair, dentist/assistant elements, and water unit. Materials comply with ISO 10993 and ISO 21530. Features include BL/BL ISO C/BL Implant motors, SPRAYVIT M syringe, and ApexLocator. Connectivity includes USB and network interfaces. Software lifecycle follows IEC 62304. Sterilization via validated methods for reusable components. Energy source: electrical. Form factor: floor-mounted unit with swiveling/sliding components.

Indications for Use

Indicated for use in dental clinics by trained dentists or dental assistants for general dental and endodontic procedures. Contraindicated for use in explosion-hazard areas, mobile vehicles, or for patients who are highly immunosuppressed or have specific pulmonary diseases (use of sterile solutions recommended).

Regulatory Classification

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.

Predicate Devices

• C8+ DENTAL OPERATIVE UNIT WITH ACCESSORIES (K032543)
• A-DEC 200 DENTAL SYSTEM (K102234)

Reference Devices

• Turbines (K131319)
• Satelec Mini LED curing light (K032465)
• HELIODENT Plus (K083344)
• SIROSONIC TL ultrasonic scaler (K033640)

Submission Summary (Full Text)

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three human profiles facing to the right, with flowing lines connecting them, representing the department's focus on people and health.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 24,2015

Sirona Dental Systems Gmbh % Mr. Kofi Aninakwa Legal Services Engineer Sirona Dental Systems, Inc. 30-30 47th Avenue, Suite 500 Long Island City, New York 11101

Re: K151045

Trade/Device Name: Teneo Dental Treatment Unit And Accessories Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit And Accessories Regulatory Class: Class I Product Code: EIA, EBW Dated: June 15, 2015 Received: June 19, 2015

Dear Mr. Kofi Aninakwa:

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

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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 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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Russo, DDS, MA

Erin Keith 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): K151045

### Device Name: TENEO DENTAL TREATMENT UNIT AND ACCESSORIES

### Indications for Use:

The dental treatment unit with accessories is intended to supply power to and serve as a base for dental devices and accessories. This product includes a dental chair. The dental treatment unit is intended for use in the dental clinic environment and is used by trained dentists and/or dental assistants.

The motors serve as drives for rotating and oscillating straight and contra-angle hand pieces in connection with a dental treatment unit. They are used for endodontic and general dental purposes.

The SPRAYVIT M multifunctional syringe is used for dental treatment with unheated air and heated water. It is also used to illuminate the preparation field.

Prescription Use (Part 21 CFR 801 Subpart D) OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

## Concurrence of CDRH, Office of Device Evaluation (ODE)

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### K151045

### 510(k) Summary

for

### Sirona Dental Systems TENEO Dental Treatment Unit and Accessories

#### 1 SPONSOR

Sirona Dental Systems GmbH Fabrikstrasse 31 64625 Bensheim Germany

Contact Person: Kofi Aninakwa Telephone: [phone] Date Prepared: July 19, 2015

#### 2 DEVICE NAME

| Proprietary Names | : TENEO Dental Treatment Unit and Accessories |
|---------------------|-----------------------------------------------|
| Common/Usual Name | : Unit, Operative Dental |
| Classification Name | : Dental operative unit and accessories. |
| Regulation Number | : 21 CFR 872.6640 |
| Product Code | : EIA, EBW |
| Device Class | : 1 |

#### 3 PREDICATE DEVICES

- C8+ DENTAL OPERATIVE UNIT WITH ACCESSORIES (K032543) . Product Code – EIA Regulation Number 21 CFR 872.6640
- A-DEC 200 DENTAL SYSTEM (K102234) . Product Code – EIA Regulation Number 21 CFR 872.6640

Sirona's C8+ is the primary predicate device for substantial equivalence as it has more similar functions as the TENEO.

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#### 4 INTENDED USE

The dental treatment unit with accessories is intended to supply power to and serve as a base for dental devices and accessories. This product includes a dental chair. The dental treatment unit is intended for use in the dental clinic environment and is used by trained dentists and/or dental assistants.

The motors serve as drives for rotating and oscillating straight and contra-angle hand pieces in connection with a dental treatment unit. They are used for endodontic and general dental purposes.

The SPRAYVIT M multifunctional syringe is used for dental treatment with unheated air and heated water. It is also used to illuminate the preparation field.

# 4.1 Contra-Indications

This dental treatment unit is not intended for operation in areas subject to explosion hazards.

This dental treatment unit is permanently installed. Operation is not permitted in mobile vehicles.

Highly immunosuppressed patients or patients with specific pulmonary diseases should not come in contact with the water of the treatment unit. The use of sterile solutions is recommended.

#### 5 DEVICE DESCRIPTION AND FUNCTION

The TENEO dental treatment unit is a dental operating system. The device includes a patient chair, foot control, dentist element, assistant element and a water unit. The unit may also include a dental operating light, and a monitor.

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#### PRINCIPLES OF OPERATION 6

The dental treatment center is designed to bring a patient into an ergonomic and comfortable position to perform dental treatment procedures. For this purpose, the patient chair can be brought into an appropriate position, either by activating the chair positioning motors or by recalled programmed positions set by the user. The headrest is adjusted manually by motor according to patient height and the area in the patient's oral cavity to be treated. The treatment is performed by the instruments placed in the designated instrument holders. The required parameters (e.g. power, torque, speed, cooling media) can be adjusted via a touch panel or recalled from settings programmed by the user beforehand. After taking an instrument from its respective holder, it can be activated via the foot control. To place dental hand instruments and materials required during treatment tray surfaces are provided.

To dispose fluids and particles deriving from the oral cavity during treatment, suction hoses with attached handpieces are provided on the assistant element. Picking the suction handpieces activates the vacuum. For disposal also a cuspidor bowl is available. The cuspidor can be manually swiyeled towards the patient chair. The cuspidor bowl automatically returns beforehand to ensure that the patient does not collide with it during chair movements.

An operating light providing illumination to the oral cavity can be switched on via the touch panel or is operated automatically in accordance with preset adjustments in connection with the pre-programmed chair positions. It can be also switched on/off via a no-touch sensor which recognizes when the hand is moved there. Most chair and instrument related functions can be activated hands-free via foot control. The foot control is also available with wireless transmission. The touch screen style user interface applies context-sensitivity; i.e. according to the actual operational state, varying buttons and functions are displayed and provided for use. Prescribed procedures and supporting components apply to facilitate infection control and maintaining water quality, such as automated suction hose and instrument hose purge, automatic dosage of waterline treatment and suction cleaning agents, integrated cleaning adapters for hoses. Water supply is also possible using self-containing systems.

As an option TENEO can integrate into a therapy package, including the endodontic and implantology functions.

The therapy package integrates electronic torque limitation and a file library, containing different current file systems and their recommended torque settings. The ApexLocator is a support function to determine the position of a file in the root canal It can be used with an x-ray image of the tooth for root canal measurements. During the endodontic treatment, the user receives file position information. This is achieved using electrical impedance with mucosal electrode and a conductive

Sirona Dental Systems 510(k) Summary

### DENTAL OPERATIVE UNITS WITH ACCESSORIES

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connection between root file and the TENEO. An acoustic signal and a diagram submit the information. Exact length measurements from the root canal file to the physiological apex (apical constriction) are not provided. The root canal has to be detected via X-ray.

Also a peristaltic pump and a NaCl bottle holder can be attached to the dentist element. The peristaltic pump prepares a sterile saline solution instead of spray water for cooling. This system connects as a "closed system" to the TENEO to ensure full sterility.

TENEO has a motor-driven headrest, which can be moved via the touchscreen or a 4-way switch at the backside of the headrest. The motor-driven headrest allows the following adjustments: extension/retraction to adapt to the patient's stature, tilting for maxillary/mandibular treatment. Moreover the removable head pad with magnetic holder allows shifting/rotation of the head support. Also a mechanical adjustment of headrest tilt is possible.

| Accessory | Product Code | Comment |
|--------------------------------------------------------------------|--------------|-------------------------------------------------------------------------------------------------|
| Motor BL | EBW | A physical part of the operative unit |
| Motor BL ISO C | EBW | A physical part of the operative unit |
| Motor BL Implant | EBW | A physical part of the operative unit |
| SPRAYVIT M | ECB | Class I, exempt under 21 CFR 872.4565 |
| SiroCam AF+ | EIA | Dental Operative Units and accessories. Only used for patient communication. Not for diagnosis. |
| Silicone pads on either dentist or assistant element | EIA | Dental Operative Units and accessories |
| Removable silicone sleeves for handles | EIA | Dental Operative Units and accessories |
| Swiveling tray support with tray tablet attached to the water unit | EIA | Dental Operative Units and accessories |
| Monitor 22" | EIA | Dental Operative Units and accessories |
| Booster cushion for small patients | EIA | Dental Operative Units and accessories |
| Suction parts | EIA | Dental Operative Units and accessories |
| Plug ball for unoccupied instrument holder | EIA | Dental Operative Units and accessories |
| ApexLocator (software, file clamp and mucosal electrode) | LQY | A physical part of the operative unit |
| Turbines | EFB | FDA Cleared - 510(k) number - K131319 |
| Satelec Mini LED curing light | EBZ | FDA Cleared - 510(k) number - K032465 |
| HELIODENT Plus | EHD | FDA Cleared - 510(k) number – K083344 |
| SIROSONIC TL ultrasonic scaler | ELC | FDA Cleared - 510(k) number – K033640 |
| LEDview | EAZ | Class I, exempt under 21 CFR 872.4630 |

Accessories
Below are the accessories o f the TENEO Dantal Treatment Unit

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#### 7 TECHNOLOGICAL CHARACTERISTICS SUMMARY

The TENEO Device has similar physical and technical characteristics to the predicate devices, as illustrated in the table below. C8+ is the primary predicate device.

| | Device | C8+ (K032543) | A-DEC 200 (K102234) | TENEO | |
|-------------------|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| Dentist Element | Intended<br>Use | The C8+ Dental<br>Operative Unit<br>with accessories is<br>intended to supply<br>power to and<br>serve as<br>a base for dental<br>devices and<br>accessories. This<br>product includes a<br>dental chair. The<br>unit is<br>intended for use in<br>the dental clinic<br>environment and<br>used by trained<br>dentists and! or<br>dental<br>technicians and<br>assistants. | The A-DEC 200 Dental<br>System and accessories<br>are intended for use in<br>general<br>dental applications by<br>providing the dental<br>practitioner a user<br>interface to control<br>operation of the dental<br>chair and attached<br>dental devices. The,<br>system delivers air,<br>water, vacuum and<br>electricity to allow the<br>dental practitioner an<br>intuitive control<br>center for all common<br>and normal patient<br>treatment procedures<br>performed in the<br>dental operatory. | This dental treatment unit with<br>accessories is intended to supply power<br>to and serve as a base for dental devices<br>and accessories. This product includes a<br>dental chair. The dental treatment unit<br>is intended for use in the dental clinic<br>environment and is used by trained<br>dentists and/or dental assistants. | |
| | Positions | 5 instrument<br>positions | 5 instruments positions | 6 handpiece positions + 1 Additional | |
| | Max.<br>Motors | Up to 2 motors | Up to 3 motors | Up to 4 motors | |
| | User<br>Interface | TouchPad (No<br>display) | Touch Pad only with<br>buttons | EasyTouch Display 7 ", colour, plus<br>Additional 13 keys (foil) and Status<br>LEDs | |
| | handsfree<br>operation by foot<br>control | handsfree operation by<br>foot control | Handsfree operation with cursor control<br>by foot control | | |
| Dentist Element | Syringe | 3-way syringe /<br>Sprayvit | 3 way | Sprayvit M with internal heater for<br>water and light | |
| Dentist Element | Turbines | Turbines | Turbines | Turbines with light | |
| Dentist Element | Motors | Motor SL (electric<br>motor) | - | Motor BL (electric motor with light) | |
| | Device | C8+ (K032543) | A-DEC 200 (K102234) | TENEO | |
| | | Motor SL ISO<br>(electric motor) | - | Motor BL ISO C (electric motor with<br>light) | |
| | | | | Motor BL implant (electric motor) | |
| | Control of<br>coolant | Water amount<br>controlled by the<br>unit | Manual knob to open or<br>close for water | Water amount controlled by the unit | |
| | | Air amount<br>controlled by the<br>unit | Manual knob to open or<br>close for air | Air amount controlled by the unit | |
| Scaler | | Sirosonic L with<br>light | yes | Sirosonic TL with light | |
| | Intraoral<br>Camera | Sirocam 3 | - | Sirocam AF+ | |
| | Curing<br>light | Mini LED | - | Mini LED (Acteon, Satelec) | |
| | X-ray<br>Viewer | X-ray viewer | X-ray image viewer | Panorama X-ray image viewer | |
| | Style of<br>dentist<br>element | Height adjustable<br>support arm (CS,<br>TS) | Adjustable arm with<br>manual knob | Motor driven sliding track | |
| | | Cart version | - | - | |
| | | swivel arms or<br>hanging hoses | hanging hoses | hanging hoses | |
| | | Additional tray at<br>dentist element | tray only on the dentist<br>element | extra tray with an arm | |
| | Endodont<br>ics | - | - | Implantology functions | |
| | | - | - | Endodontic treatment functions | |
| | | - | - | Integrated pump for saline solution | |
| | | - | - | Integrated Apex locator function | |
| | Interfaces | - | - | USB interface | |
| Assistant Element | Positions | 3 handpiece<br>positions | 3 handpiece positions | 4 handpiece positions | |
| | User<br>Interface | Touch pad | Touch pad | Touch pad (foil) with 12 keys and status<br>LEDs | |
| | Syringe | 3-way syringe /<br>Sprayvit | 3-way syringe | Sprayvit M with internal heater for<br>water | |
| | Device | C8+ (K032543) | A-DEC 200 (K102234) | TENEO | |
| | Curing<br>light | Mini LED | - | Mini LED (Acteon, Satelec) | |
| | Suction | Suction devices<br>Saliva ejector<br>HVE (High volume<br>evacuator) | Suction devices<br>Saliva ejector<br>HVE (High volume<br>evacuator) | Suction devices<br>Saliva ejector<br>HVE (High volume evacuator)<br>Surgical suction devices | |
| | | Interfaces | -<br>Hydrocolloid port | - | USB interface<br>Hydrocolloid port |
| | | Patient<br>load | Max. 135kg + 5 kg<br>accessories | 181 kg | Max. 160kg + 5 kg accessories |
| | Headrest | Flat headrest | Headrest | Motorized headrest | |
| | Upholstery | Standard/lounge<br>upholstery (sleek<br>style) | Upholstery Care (sleek<br>style) | Thermo upholstery / lounge upholstery<br>(sleek style) | |
| | Arm Rest | Arm rest | Arm rest | Arm rest removable | |
| | Switch | Yes | - | 4-way foot-switch | |
| Chair | Movement | Synchronized<br>Backrest and seat<br>movements<br>-<br>User<br>programmable<br>positions<br>Backrest motor<br>driven<br>Seat motor driven | -<br>-<br>User programmable<br>positions<br>Backrest motor driven<br>Seat motor driven | Synchronized Backrest and seat<br>movements<br>External device connection<br>Massage and lumbar support function<br>User programmable positions<br>Backrest motor driven<br>Seat and seat inclination motor driven | |
| Water unit | | Cuspidor<br>bowl | Cuspidor bowl | Cuspidor | Motor driven cuspidor bowl |
| | | Amalgam<br>separator | Amalgam<br>separator | Amalgam separator | Amalgam separator |
| | | Water | Fresh water<br>bottle/Connection<br>to municipal water | Fresh water bottle | Connection to municipal water |
| | | Heating | Water heater | - | Water heater |
| | | Device | C8+ (K032543) | A-DEC 200 (K102234) | TENEO |
| General | Water /<br>Suction<br>hose<br>treat-<br>ment | Water treatment<br>with continuous<br>sanitization<br>function | Put tablets in the water<br>bottle | Water treatment with permanent<br>sanitization function | |
| | | Suction hose<br>cleaning with<br>water | Suction hose cleaning<br>with water | Suction hose cleaning with water | |
| | | only by flushing<br>with water | only by flushing with<br>water | Suction hose cleaning with chemicals | |
| | Water<br>treatment | Waterline<br>Treatment<br>solution…