(95 days)
Not Found
No
The summary describes a standard dental treatment unit with accessories and does not mention any AI or ML capabilities.
Yes.
The device includes a dental chair, motors for handpieces, and a multifunctional syringe, all of which are used in conjunction with a dental treatment unit to perform dental procedures (e.g., endodontic and general dental purposes), indicating a direct therapeutic function.
No
The device is described as a "dental treatment unit" and "dental operating system" that supplies power to and serves as a base for dental devices. Its primary functions involve providing various services (e.g., power, water, air, light) to facilitate dental procedures, rather than diagnosing conditions. The "clinical assessment" mentioned is for evaluating the device's ability to fulfill its intended use, not for diagnosing patient conditions.
No
The device description explicitly lists multiple hardware components including a patient chair, foot control, dentist element, assistant element, water unit, operating light, and monitor. The performance studies also mention testing of sterilizable components and accessories, further indicating a hardware-based device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a dental treatment unit used to supply power and serve as a base for dental devices and accessories, including a dental chair, motors for handpieces, and a multifunctional syringe for air and water. These are all tools used directly in the treatment of patients within the oral cavity.
- IVD Definition: In vitro diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform any such examination of specimens.
- Device Description: The description details the physical components of a dental operating system, all of which are used for direct patient care.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing diagnostic tests on specimens, or providing diagnostic information based on laboratory analysis.
The device is a piece of dental equipment used for performing dental procedures, not for in vitro diagnostic testing.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
EIA, EBW
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.
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
dental clinic environment and is used by trained dentists and/or dental assistants.
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
A test concept along with the acceptance criteria have been provided. Additional information concerning system and component tests and traceability analysis has been provided.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Sterilization tests for the sterilizable TENEO components as well as for the accessories have been provided. Biocompatibility tests for these components and accessories have also been conducted and provided.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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" 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
1
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
2
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)
3
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.
4
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.
5
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
6
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
7
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 | ||||
| Use | The C8+ Dental | ||||
| Operative 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 | |||||
| unit is | |||||
| intended for use in | |||||
| the dental clinic | |||||
| environment and | |||||
| used by trained | |||||
| dentists and! or | |||||
| dental | |||||
| technicians and | |||||
| assistants. | The A-DEC 200 Dental | ||||
| System and accessories | |||||
| are intended for use in | |||||
| general | |||||
| dental applications by | |||||
| providing the dental | |||||
| practitioner a user | |||||
| interface to control | |||||
| operation of the dental | |||||
| chair and attached | |||||
| dental devices. The, | |||||
| system delivers air, | |||||
| water, vacuum and | |||||
| electricity to allow the | |||||
| dental practitioner an | |||||
| intuitive control | |||||
| center for all common | |||||
| and normal patient | |||||
| treatment procedures | |||||
| performed in the | |||||
| dental operatory. | This 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. | |||||
| Positions | 5 instrument | ||||
| positions | 5 instruments positions | 6 handpiece positions + 1 Additional | |||
| Max. | |||||
| Motors | Up to 2 motors | Up to 3 motors | Up to 4 motors | ||
| User | |||||
| Interface | TouchPad (No | ||||
| display) | Touch Pad only with | ||||
| buttons | EasyTouch Display 7 ", colour, plus | ||||
| Additional 13 keys (foil) and Status | |||||
| LEDs | |||||
| handsfree | |||||
| operation by foot | |||||
| control | handsfree operation by | ||||
| foot control | Handsfree operation with cursor control | ||||
| by foot control | |||||
| Dentist Element | Syringe | 3-way syringe / | |||
| Sprayvit | 3 way | Sprayvit M with internal heater for | |||
| water and light | |||||
| Dentist Element | Turbines | Turbines | Turbines | Turbines with light | |
| Dentist Element | Motors | Motor SL (electric | |||
| motor) | - | 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 with | |||
| light) | |||||
| Motor BL implant (electric motor) | |||||
| Control of | |||||
| coolant | Water amount | ||||
| controlled by the | |||||
| unit | Manual knob to open or | ||||
| close for water | Water amount controlled by the unit | ||||
| Air amount | |||||
| controlled by the | |||||
| unit | Manual knob to open or | ||||
| close for air | Air amount controlled by the unit | ||||
| Scaler | Sirosonic L with | ||||
| light | yes | Sirosonic TL with light | |||
| Intraoral | |||||
| Camera | Sirocam 3 | - | Sirocam AF+ | ||
| Curing | |||||
| light | Mini LED | - | Mini LED (Acteon, Satelec) | ||
| X-ray | |||||
| Viewer | X-ray viewer | X-ray image viewer | Panorama X-ray image viewer | ||
| Style of | |||||
| dentist | |||||
| element | Height adjustable | ||||
| support arm (CS, | |||||
| TS) | Adjustable arm with | ||||
| manual knob | Motor driven sliding track | ||||
| Cart version | - | - | |||
| swivel arms or | |||||
| hanging hoses | hanging hoses | hanging hoses | |||
| Additional tray at | |||||
| dentist element | tray only on the dentist | ||||
| element | extra tray with an arm | ||||
| Endodont | |||||
| ics | - | - | Implantology functions | ||
| - | - | Endodontic treatment functions | |||
| - | - | Integrated pump for saline solution | |||
| - | - | Integrated Apex locator function | |||
| Interfaces | - | - | USB interface | ||
| Assistant Element | Positions | 3 handpiece | |||
| positions | 3 handpiece positions | 4 handpiece positions | |||
| User | |||||
| Interface | Touch pad | Touch pad | Touch pad (foil) with 12 keys and status | ||
| LEDs | |||||
| Syringe | 3-way syringe / | ||||
| Sprayvit | 3-way syringe | Sprayvit M with internal heater for | |||
| water | |||||
| Device | C8+ (K032543) | A-DEC 200 (K102234) | TENEO | ||
| Curing | |||||
| light | Mini LED | - | Mini LED (Acteon, Satelec) | ||
| Suction | Suction devices | ||||
| Saliva ejector | |||||
| HVE (High volume | |||||
| evacuator) | Suction devices | ||||
| Saliva ejector | |||||
| HVE (High volume | |||||
| evacuator) | Suction devices | ||||
| Saliva ejector | |||||
| HVE (High volume evacuator) | |||||
| Surgical suction devices | |||||
| Interfaces | - | ||||
| Hydrocolloid port | - | USB interface | |||
| Hydrocolloid port | |||||
| Patient | |||||
| load | Max. 135kg + 5 kg | ||||
| accessories | 181 kg | Max. 160kg + 5 kg accessories | |||
| Headrest | Flat headrest | Headrest | Motorized headrest | ||
| Upholstery | Standard/lounge | ||||
| upholstery (sleek | |||||
| style) | Upholstery Care (sleek | ||||
| style) | Thermo upholstery / lounge upholstery | ||||
| (sleek style) | |||||
| Arm Rest | Arm rest | Arm rest | Arm rest removable | ||
| Switch | Yes | - | 4-way foot-switch | ||
| Chair | Movement | Synchronized | |||
| Backrest and seat | |||||
| movements |
User
programmable
positions
Backrest motor
driven
Seat motor driven | -
User programmable
positions
Backrest motor driven
Seat motor driven | Synchronized Backrest and seat
movements
External device connection
Massage and lumbar support function
User programmable positions
Backrest motor driven
Seat and seat inclination motor driven | |
| Water unit | | Cuspidor
bowl | Cuspidor bowl | Cuspidor | Motor driven cuspidor bowl |
| | | Amalgam
separator | Amalgam
separator | Amalgam separator | Amalgam separator |
| | | Water | Fresh water
bottle/Connection
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 /
Suction
hose
treat-
ment | Water treatment
with continuous
sanitization
function | Put tablets in the water
bottle | Water treatment with permanent
sanitization function | |
| | | Suction hose
cleaning with
water | Suction hose cleaning
with water | Suction hose cleaning with water | |
| | | only by flushing
with water | only by flushing with
water | Suction hose cleaning with chemicals | |
| | Water
treatment | Waterline
Treatment
solution | A-dec ICX Waterline
Treatment tablets | Waterline Treatment solution | |
| | Purge | Purge function | only by flushing with
water | Purge function with auto purge | |
| | Operating
Light | LEDview
Sirolux E | LED light | LEDview | |
| | | Monitor | 22" monitor on the
light support
column | | |
| | Foot
Control | Pneumatic Foot
control available | Foot Switch | Wireless Foot control available | |
| | | Electronic foot
control | Foot Control | Electronic foot control | |
| | PC
Interface | | | Network interface | |
8
9
10
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.
11
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
12
- 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.