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 Description

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.

AI/ML Overview

The provided text is a 510(k) Summary for the Sirona Dental Systems TENEO Dental Treatment Unit and Accessories. It focuses on demonstrating substantial equivalence to predicate devices, and as such, it does not contain the information requested about acceptance criteria and a study proving the device meets those criteria for software or AI performance.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The document primarily discusses:

Intended Use and Device Description: What the device does and its components.
Technological Characteristics Comparison: A detailed table comparing the TENEO device to two predicate devices (C8+ and A-DEC 200) across various features like dentist element, assistant element, chair, water unit, and general characteristics. This comparison is to establish substantial equivalence.
Performance Data (General): It mentions a "clinical assessment has been conducted for the TENEO by a dentist," that a "test concept along with the acceptance criteria have been provided," and that "Additional information concerning system and component tests and traceability analysis has been provided." It also references sterilization and biocompatibility tests, and compliance with various international and national performance standards (ISO, AAMI, IEC, EN, DIN) related to dental units, biocompatibility, risk management, electrical safety, usability, software lifecycle, photobiological safety, and sterilization.

However, it does not provide the actual acceptance criteria values or the specific results of a study demonstrating fulfillment of those criteria in a quantitative manner. It certainly does not mention anything related to AI, machine learning, or algorithms.

Summary

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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 (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 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 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: 718-482-2248 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 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

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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	IntendedUse	The C8+ DentalOperative Unitwith accessories isintended to supplypower to andserve asa base for dentaldevices andaccessories. Thisproduct includes adental chair. Theunit isintended for use inthe dental clinicenvironment andused by traineddentists and! ordentaltechnicians andassistants.	The A-DEC 200 DentalSystem and accessoriesare intended for use ingeneraldental applications byproviding the dentalpractitioner a userinterface to controloperation of the dentalchair and attacheddental devices. The,system delivers air,water, vacuum andelectricity to allow thedental practitioner anintuitive controlcenter for all commonand normal patienttreatment proceduresperformed in thedental operatory.	This dental treatment unit withaccessories is intended to supply powerto and serve as a base for dental devicesand accessories. This product includes adental chair. The dental treatment unitis intended for use in the dental clinicenvironment and is used by traineddentists and/or dental assistants.
	Positions	5 instrumentpositions	5 instruments positions	6 handpiece positions + 1 Additional
	Max.Motors	Up to 2 motors	Up to 3 motors	Up to 4 motors
	UserInterface	TouchPad (Nodisplay)	Touch Pad only withbuttons	EasyTouch Display 7 ", colour, plusAdditional 13 keys (foil) and StatusLEDs
	handsfreeoperation by footcontrol	handsfree operation byfoot control	Handsfree operation with cursor controlby foot control
Dentist Element	Syringe	3-way syringe /Sprayvit	3 way	Sprayvit M with internal heater forwater and light
Dentist Element	Turbines	Turbines	Turbines	Turbines with light
Dentist Element	Motors	Motor SL (electricmotor)	-	Motor BL (electric motor with light)
	Device	C8+ (K032543)	A-DEC 200 (K102234)	TENEO
		Motor SL ISO(electric motor)	-	Motor BL ISO C (electric motor withlight)
				Motor BL implant (electric motor)
	Control ofcoolant	Water amountcontrolled by theunit	Manual knob to open orclose for water	Water amount controlled by the unit
		Air amountcontrolled by theunit	Manual knob to open orclose for air	Air amount controlled by the unit
Scaler		Sirosonic L withlight	yes	Sirosonic TL with light
	IntraoralCamera	Sirocam 3	-	Sirocam AF+
	Curinglight	Mini LED	-	Mini LED (Acteon, Satelec)
	X-rayViewer	X-ray viewer	X-ray image viewer	Panorama X-ray image viewer
	Style ofdentistelement	Height adjustablesupport arm (CS,TS)	Adjustable arm withmanual knob	Motor driven sliding track
		Cart version	-	-
		swivel arms orhanging hoses	hanging hoses	hanging hoses
		Additional tray atdentist element	tray only on the dentistelement	extra tray with an arm
	Endodontics	-	-	Implantology functions
		-	-	Endodontic treatment functions
		-	-	Integrated pump for saline solution
		-	-	Integrated Apex locator function
	Interfaces	-	-	USB interface
Assistant Element	Positions	3 handpiecepositions	3 handpiece positions	4 handpiece positions
	UserInterface	Touch pad	Touch pad	Touch pad (foil) with 12 keys and statusLEDs
	Syringe	3-way syringe /Sprayvit	3-way syringe	Sprayvit M with internal heater forwater
	Device	C8+ (K032543)	A-DEC 200 (K102234)	TENEO
	Curinglight	Mini LED	-	Mini LED (Acteon, Satelec)
	Suction	Suction devicesSaliva ejectorHVE (High volumeevacuator)	Suction devicesSaliva ejectorHVE (High volumeevacuator)	Suction devicesSaliva ejectorHVE (High volume evacuator)Surgical suction devices
		Interfaces	-Hydrocolloid port	-	USB interfaceHydrocolloid port
		Patientload	Max. 135kg + 5 kgaccessories	181 kg	Max. 160kg + 5 kg accessories
	Headrest	Flat headrest	Headrest	Motorized headrest
	Upholstery	Standard/loungeupholstery (sleekstyle)	Upholstery Care (sleekstyle)	Thermo upholstery / lounge upholstery(sleek style)
	Arm Rest	Arm rest	Arm rest	Arm rest removable
	Switch	Yes	-	4-way foot-switch
Chair	Movement	SynchronizedBackrest and seatmovements-UserprogrammablepositionsBackrest motordrivenSeat motor driven	--User programmablepositionsBackrest motor drivenSeat motor driven	Synchronized Backrest and seatmovementsExternal device connectionMassage and lumbar support functionUser programmable positionsBackrest motor drivenSeat and seat inclination motor driven
Water unit		Cuspidorbowl	Cuspidor bowl	Cuspidor	Motor driven cuspidor bowl
		Amalgamseparator	Amalgamseparator	Amalgam separator	Amalgam separator
		Water	Fresh waterbottle/Connectionto municipal water	Fresh water bottle	Connection to municipal water
		Heating	Water heater	-	Water heater
		Device	C8+ (K032543)	A-DEC 200 (K102234)	TENEO
General	Water /Suctionhosetreat-ment	Water treatmentwith continuoussanitizationfunction	Put tablets in the waterbottle	Water treatment with permanentsanitization function
		Suction hosecleaning withwater	Suction hose cleaningwith water	Suction hose cleaning with water
		only by flushingwith water	only by flushing withwater	Suction hose cleaning with chemicals
	Watertreatment	WaterlineTreatmentsolution	A-dec ICX WaterlineTreatment tablets	Waterline Treatment solution
	Purge	Purge function	only by flushing withwater	Purge function with auto purge
	OperatingLight	LEDviewSirolux E	LED light	LEDview
		Monitor	22" monitor on thelight supportcolumn
	FootControl	Pneumatic Footcontrol available	Foot Switch	Wireless Foot control available
		Electronic footcontrol	Foot Control	Electronic foot control
	PCInterface			Network interface

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8 PERFORMANCE DATA

The clinical assessment has been conducted for the TENEO by a dentist. TENEO's ability to fulfill the applications for which it is intended is evaluated in a critical analysis of the benefit-risk ratio by a dental practitioner.

A test concept along with the acceptance criteria have been provided. Additional information concerning system and component tests and traceability analysis has been provided.

Sterilization tests for the sterilizable TENEO components as well as for the accessories have been provided.

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Biocompatibility tests for these components and accessories have also been conducted and provided.

The Sirona TENEO Dental Treatment Unit and its accessories also comply with the following performance standards:

. Dentistry - Dental units - Part 1: ISO 7494-1 Second edition 2011-08-15 General requirements and test methods
Dentistry Dental units Part 2: ● ISO 7494-2 First edition 2003-03-01 Water and air supply
AAMI ANSI ISO 10993-1:2009/(R) 2013 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
ISO 14971 Second edition 2007-03-01 Medical devices - Application of risk management to medical devices
. ANSI/AAMI ES60601-1:2005/(R)2012 and C1:2009/(R)2012 and A2:2010/(R)2012 electrical equipment -- Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
. 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
. IEC 60601-1-6 Edition 3.0 2010-01Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance --Collaterial Standard: Usability
IEC 62304 First edition 2006-05 Medical device software - Software lifecycle processes
IEC 62366 Edition 1.1 2014-01 engineering to medical devices
. IEC 62471 First edition 2006-07 svstems

ISO 14457 First Edition 2012-09-15

●

Dentistry Handpieces And Motors
Medical devices - Application of usability

Photobiological safety of lamps and lamp

ISO 7405 Second Edition 2008-12-15 Dentistry - Evaluation Of Biocompatibility Of Medical Devices Used In Dentistry [Including: Amendment 1 (2013)]
ISO 15223-1 Second Edition 2012-07-01 Medical Devices - Symbols To Be Used With Medical Device Labels, Labeling, And Information To Be Supplied -Part 1: General Requirements
. AAMI ANSI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Comprehensive Guide To Steam Sterilization And Sterility Assurance In Health Care Facilities
ISO 10993-10 Third Edition 2010-08-01 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization

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EN 1717:2000 Protection against pollution of potable water ● installations and general requirements of devices to prevent pollution by backflow
DIN 6856-3 Radiological film viewing boxes and viewing conditions - Part ● 3: Radiological film viewing boxes for dentistry
ISO 6875:2011 Dental patient chair Dentistry -
ISO 9680:2007 ● Operating lights Dentistry -
ISO 11143:2008 Amalgam separators
. ISO 13485:2003 with Technical Corrigendum 1:2009 Medical devices -Ouality management systems
ISO 21530:2004 Dentistry - Materials used for dental equipment surfaces - Determination of resistance to chemical disinfectants
IEC 80601-2-60:2012 ● Medical electrical equipment - Part 2-60: Particular requirements for basic safety and essential performance of dental equipment
ISO 17664:2004 Sterilization of medical devices -- Information to be provided by the manufacturer for the processing of resterilizable medical devices
Dentistry -- Graphical symbols for dental instruments ● ISO 21531:2009
ISO 3964 : 1982 Dental handpieces – Coupling dimensions
DIN EN ISO 10993-5 2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity Motors

9 CONCLUSION

Based on a comparison of intented use, indication, construction materials, principle of operation, features and technical data, the TENEO Dental Treatment unit with accessories is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 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.