(105 days)
No
The summary describes a standard dental treatment unit and its accessories, focusing on mechanical and ergonomic features. There is no mention of AI or ML capabilities.
No.
The device description indicates that the INTEGO Family of Dental Treatment Units with accessories is intended to supply power to and serve as a base for dental devices and accessories, including a dental chair. It is described as a dental operating system whose design aids ergonomic treatment for dentists and assistants, facilitates cleaning and infection control, and provides an intuitive workflow. While it supports other dental devices used for treatment (e.g., MOTOR BL ISO E for driving handpieces, SPRAYVIT E multifunctional syringe for air/water/illumination), the unit itself does not directly apply or provide therapy. It is an infrastructure or platform for therapeutic devices, not a therapeutic device in itself.
No
The device description indicates that the INTEGO family dental treatment unit is a "dental operating system" and is used to "supply power to and serve as a base for dental devices and accessories" and for "driving rotating and oscillating straight and contra-angle handpieces" and for "dental treatment with unheated air and unheated water" and "to illuminate the preparation field". There is no mention of the device being used to diagnose conditions or diseases.
No
The device description clearly outlines physical components such as a dental chair, foot control, dentist element, water unit, assistant element, cuspidor, dental operating light, and monitor, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for supplying power to and serving as a base for dental devices and accessories, and for use in dental treatments. This involves direct interaction with the patient's mouth and teeth, not the examination of specimens derived from the human body.
- Device Description: The description details a dental operating system including a chair, foot control, dentist element, water unit, etc. These are all components of a system used for performing dental procedures on a patient.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, urine, tissue, etc.) to provide information about a physiological state, health, disease, or congenital abnormality.
IVD devices are specifically designed to be used in vitro (outside the body) to analyze biological samples. This device is used in vivo (on the body) for dental treatment.
N/A
Intended Use / Indications for Use
The INTEGO Family of Dental Treatment Units with accessories is intended to supply power to and serve as a base for dental devices and accessories. Each unit includes a dental chair. The units are intended for use in the dental clinic environment and are used by trained dentists and/or dental assistants.
The MOTOR BL ISO E is used to drive rotating and oscillating straight and contra-angle handpieces in connection with the dental treatment units for endodontic and general dental purposes.
The SPRAYVIT E multifunctional syringe is used for dental treatment with unheated air and unheated water. The SPRAYVIT E multifunctional syringe is also used to illuminate the preparation field.
Product codes
EIA, EBW
Device Description
The INTEGO family dental treatment unit is a dental operating system. INTEGO and INTEGO pro dental treatment units constitute the INTEGO Family. These are the successors of C8+. Components and functional principles are taken over or widely derived from this C8+. The units include a patient chair, foot control, dentist element and a water unit. The units may also include an assistant element, a cuspidor a dental operating light, and a monitor.
The design concept of the INTEGO treatment unit is similar to commonly available treatment units.
The dimensions of the components, their movements and shapes are designed for ergonomic treatment; i.e. the dentist and, where applicable, the assistant can perform their treatments in a healthy working posture.
Surfaces are smooth to enable easy cleaning and disinfecting. This simplifies, in line with detachable parts and barriers as well as simple maintenance routines, efficient infection control.
The operating concept is designed to make treatments easy and intuitive to prevent mal-operations and provide an unimpeded workflow. Depending on the selected foot control and user interface version, a significant portion of functions can be operated hands-free to improve infection control and treatment workflow.
Styling and colors were selected under aesthetic aspects.
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
used by trained dentists and/or dental assistants.
dental clinic environment
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)
Non Clinical Testing:
An evaluation using relevant literature and a critical appraisal of the Dental Treatment Unit and accessories by a medical professional have been performed. Sirona's motors pass applicable recognized consensus standards for product code EBW. FDA cleared standalone motors also pass these applicable consensus standards. As such Sirona's motors are comparable to their standalone counterparts. The Sirona INTEGO Family and Accessories also comply with the following performance standards:
- ISO 7494-1 Second edition 2011-08-15 ● Dentistry-Dentalunits-Part1: General requirements and test methods
- ISO 7494-2 First edition 2003-03-01 Water and air supply
- Dentistry Dental units Part 2:
- 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 Secondedition 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 -- Collateral Standard: Usability
- . IEC 62304 First edition 2006-05 Medical device software - Software lifecycle processes
- . IEC 62366 Edition 1.1 2014-01 Medical devices - Application of usability engineering to medical devices
- IEC 62471 First edition 2006-07 Photobiological safety of lamps and lamp ● systems
- ISO 14457 First Edition 2012-09-15
- Dentistry Handpieces And Motors
- 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
- . EN 1717:2000 Protection against pollution of potable water installations and general requirements of devices to prevent pollution by backflow
- DIN6856-3 Radiological film viewing boxes and viewing conditions - Part 3: Radiological film viewing boxes for dentistry
- ISO 6875:2011 Dental patient chair ●
- ISO 9680:2007 Dentistry-Operatinglights ●
- ISO 11143:2008 Dentistry-Amalgam separators
- ISO 13485:2003 with Technical Corrigendum 1:2009 . Medical devices -Quality 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
- ISO 21531:2009 Dentistry -- Graphicalsymbols for dental instruments ●
- 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a flowing design element connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 17, 2015
Sirona Dental Systems Gmbh % Kofi Aninakwa Legal Services Engineer Sirona Dental Systems. Inc. 30-30 47th Avenue, Suite 500 Long Island City, NY 11101
Re: K150909
Trade/Device Name: Intego Family 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 17, 2015 Received: June 19, 2015
Dear Mr. 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,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH 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
2
510(k) Number (if known): K150909
Device Name: INTEGO FAMILY AND ACCESSORIES
Indications for Use:
The INTEGO Family of Dental Treatment Units with accessories is intended to supply power to and serve as a base for dental devices and accessories. Each unit includes a dental chair. The units are intended for use in the dental clinic environment and are used by trained dentists and/or dental assistants.
The MOTOR BL ISO E is used to drive rotating and oscillating straight and contra-angle handpieces in connection with the dental treatment units for endodontic and general dental purposes.
The SPRAYVIT E multifunctional syringe is used for dental treatment with unheated air and unheated water. The SPRAYVIT E multifunctional syringe is also used to illuminate the preparation field.
Prescription Use _X (Part 21 CFR 801 Subpart D) Over-The-Counter Use _____ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
510(k) Summary
for
Sirona Dental Systems INTEGO FAMILY and ACCESSORIES
SPONSOR 1
Sirona Dental Systems GmbH
Fabrikstrasse 31
64625 Bensheim
Germany
Contact Person: Kofi Aninakwa
Telephone: 718- 482 -2248
Date Prepared: July 16 2015
2 DEVICE NAME
| Proprietary Names | : INTEGO Family and Accessories |
|---|---|
| Common/Usual Name | : Unit, Operative Dental |
| Classification Name | : Dental operative unit and accessories. |
| Regulation Number | : 21 CFR 872.6640 |
| Class | : 1 |
| Product Code | : EIA |
| Secondary Product Code | : EBW |
3 PREDICATE DEVICES
C8+ DENTAL OPERATIVE UNIT WITH ACCESSORIES - (K032543 - Primary Predicate) A-DEC 200 DENTAL SYSTEM - (K102234 - Reference Predicate)
4 INTENDED USE
The INTEGO Family of Dental Treatment Units with accessories is intended to supply power to and serve as a base for dental devices and accessories. Each unit includes a dental chair. The units are intended for use in the dental clinic environment and are used by trained dentists and/or dental assistants.
The MOTOR BL ISO E is used to drive rotating and oscillating straight and contraangle handpieces in connection with the dental treatment units for endodontic and
4
general dental purposes.
The SPRAYVIT E multifunctional syringe is used for dental treatment with unheated air and unheated water. The SPRAYVIT E multifunctional syringe 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. In this case the use of sterile solutions is recommended.
5 DEVICE DESCRIPTION AND FUNCTION
The INTEGO family dental treatment unit is a dental operating system. INTEGO and INTEGO pro dental treatment units constitute the INTEGO Family. These are the successors of C8+. Components and functional principles are taken over or widely derived from this C8+. The units include a patient chair, foot control, dentist element and a water unit. The units may also include an assistant element, a cuspidor a dental operating light, and a monitor.
The design concept of the INTEGO treatment unit is similar to commonly available treatment units.
The dimensions of the components, their movements and shapes are designed for ergonomic treatment; i.e. the dentist and, where applicable, the assistant can perform their treatments in a healthy working posture.
Surfaces are smooth to enable easy cleaning and disinfecting. This simplifies, in line with detachable parts and barriers as well as simple maintenance routines, efficient infection control.
The operating concept is designed to make treatments easy and intuitive to prevent mal-operations and provide an unimpeded workflow. Depending on the selected foot control and user interface version, a significant portion of functions can be operated hands-free to improve infection control and treatment workflow.
Styling and colors were selected under aesthetic aspects.
6 LEVEL OF CONCERN
The software was determined to be of a MODERATE level of concern because the software does not control a life-supporting or life-sustaining device, does not
5
control delivery of harmful energy, does not provide diagnostic information as a basis for treatment or therapy, and does not perform vital signs monitoring. However a latent design flaw or malfunction of the system software, though improbable, would result in minor injury to the patient or operator. Software documents consistent with the requirements for MODERATE level of concern software, as specified in FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, were provided.
6
7 TECHNOLOGICAL CHARACTERISTICS SUMMARY
The INTEGO Family and Accessories has similar physical and technical characteristics to the predicate devices, as illustrated in the table below. As shown in the substantial equivalence table below, there are only minor differences between the proposed and predicate devices and nothing significant that would render the device non-substantially equivalent. The entire Indications for use for the Intego Family and Accessories include language for the MOTOR BL ISO E and SPRAYVIT E. These accessories have been tested and comply with applicable recognized consensus standards and are comparable to FDA cleared counterparts. As such the overall differences between the indications for use of the INTEGO Family and Accessories and predicate C8+ do not affect the safety and effectiveness of the INTEGO Family and Accessories.
| | Device | C8+
(K032543) | A-DEC 200
(K102234) | INTEGO Family |
|-------------------|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Intended
Use | The CS+ 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-Dec200 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. | The INTEGO Family of Dental
Operative Units with accessories
is intended to supply power to
and serve as a base for dental
devices and accessories. Each
unit includes a dental chair. The
units are intended for use in the
dental clinic environment and
are used by trained dentists
and/or dental assistants. |
| | Positions | 5 instrument
positions | 5 instruments
positions | 5 instrument positions + 1
Additional |
| Dentist Element | Max. Motors | Up to 2 motors | Up to 3 motors | Up to 2 drill drives |
| | User
Interface | TouchPad (No
display) | Touch Pad only with
buttons | Touchpad (EasyPad) with 7-
segment display |
| | | | | Touch display (EasyTouch)
Display |
| | Device | C8+
(K032543) | A-DEC 200
(K102234) | INTEGO Family |
| | | handsfree
operation by
foot control | handsfree operation
by foot control | Handsfree operation with cursor
control (with EasyTouch)
4.3" (optional) |
| | Syringe | 3-way syringe
/ Sprayvit | 3 way | 3 way syringe / Sprayvit E with light |
| | Turbines | Turbines | Turbines | Turbines with light |
| | Motors | Motor SL
(electric
motor) | . | Motor BL ISO E (electric motor with
light) |
| | | Motor SL ISO
(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 L with light |
| | Intraoral
Camera | Sirocam 3 | . | Sirocam F / Sirocam AF |
| | Curing light | Mini LED
(Acteon
Satelec) | . | Mini LED (Acteon, Satelec) |
| | X-ray
Viewer | X-ray viewer | X-ray image viewer | X-ray image viewer |
| | Style of
dentist
element | Height
adjustable
support arm
(CS, TS) | Adjustable arm with
manual knob | Height adjustable support arm with
pneumatic brake |
| | | Cart version | . | |
| | | swivel arms or
hanging hoses | hanging hoses | swivel arms or hanging hoses (CS /
TS) |
| | | Additional tray | tray only on the | Additional tray at dentist element |
| | Device | C8+
(K032543) | A-DEC 200
(K102234) | INTEGO Family |
| Assistant Element | | at dentist
element | dentist element | |
| | Endodontics | . | . | Torque control kit |
| | Interfaces | . | . | USB interface |
| | Positions | 3 handpiece
positions | 3 handpiece positions | 4 handpiece positions |
| | User
Interface | Touch pad | Touch pad | Touch pad |
| | Syringe | 3-way syringe
/ Sprayvit | 3-way syringe | 3 way syringe / Sprayvit E with light |
| | Curing light | Mini LED
(Acteon
Satelec) | . | Mini LED |
| | Suction | Suction devices | Suction devices | Suction devices |
| | | Saliva ejector | Saliva ejector | Saliva ejector |
| Chair | | | HVE (High
volume
evacuator) | HVE (High volume
evacuator) |
| | Interfaces | . | . | USB interface |
| | | Hydrocolloid
port | . | Hydrocolloid port |
| | Patient load | Max. 135kg + 5
kg accessories | 181 kg | Max. 135kg + 5 kg accessories / Max.
180kg + 5 kg accessories (optional) |
| | Headrest | Flat headrest | double-articulating
headrest | Flat headrest |
| | | Articulating
headrest | . | Double articulated headrest |
| | Upholstery | Standard/lounge
upholstery
(sleek style) | Upholstery Care
(sleek style) | Thermo upholstery (sleek style) |
| | Arm Rest | Arm rest | Arm rest | Arm rest |
| | Switch | 4-way foot-
switch | . | 4-ay foot-switch |
July 16, 2015
7
8
9
| | Device | C8+
(K032543) | A-DEC 200
(K102234) | INTEGO Family |
|------------|-------------------------------------------|-------------------------------------------------------------------|------------------------------------------|---------------------------------------------------------|
| | Movement | Synchronized
Backrest and
seat
movements | . | Synchronized Backrest and seat
movements |
| | | . | . | External device connection |
| | | . | . | Pressure reduction kit |
| | | User
programmable
positions | User programmable
positions | User programmable positions |
| | | Backrest
motor driven | Backrest motor
driven | Backrest motor driven |
| | | Seat motor
driven | Seat motor driven | Seat motor driven |
| | Cuspidor
bowl | Cuspidor bowl | Cuspidor | Cuspidor bowl |
| | Amalgam
separator | Amalgam
separator | Amalgam separator | Amalgam separator |
| | Water | Fresh water
bottle/
Connection to
municipal
water | Fresh water bottle | Fresh water bottle / Connection to
municipal water |
| Water unit | Heating | Water heater | . | Water heater |
| | 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 | Dentosept P
Waterline
Treatment | A-dec ICX Waterline
Treatment tablets | Dentosept P Waterline Treatment
solution |
10
| Device | C8+ (K032543) | A-DEC 200 (K102234) | INTEGO Family | |
|---|---|---|---|---|
| General | solution | |||
| Purge | Purge function | only by flushing with water | Purge function with auto purge | |
| Operating | ||||
| Light | LEDview | |||
| Sirolux E | LED light | LEDview | ||
| LEDlight | ||||
| Monitor | 22" monitor on the light support column | 22" monitor (with integrated power supply) on light support column | ||
| Foot Control | Pneumatic Foot control available | |||
| Electronic foot control | Foot Switch | |||
| Foot Control | Pneumatic Foot control available | |||
| Electronic foot control | ||||
| PC Interface | Network interface |
NON CLINICAL TESTING 8
An evaluation using relevant literature and a critical appraisal of the Dental Treatment Unit and accessories by a medical professional have been performed. Sirona's motors pass applicable recognized consensus standards for product code EBW. FDA cleared standalone motors also pass these applicable consensus standards. As such Sirona's motors are comparable to their standalone counterparts. The Sirona INTEGO Family and Accessories also comply with the following performance standards:
- ISO 7494-1 Second edition 2011-08-15 ● Dentistry-Dentalunits-Part1: General requirements and test methods
- ISO 7494-2 First edition 2003-03-01 Water and air supply
- Dentistry Dental units Part 2:
- 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 Secondedition 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)
11
- 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 -- Collateral Standard: Usability
- . IEC 62304 First edition 2006-05 Medical device software - Software lifecycle processes
- . IEC 62366 Edition 1.1 2014-01 Medical devices - Application of usability engineering to medical devices
- IEC 62471 First edition 2006-07 Photobiological safety of lamps and lamp ● systems
- ISO 14457 First Edition 2012-09-15
- Dentistry Handpieces And Motors
- 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
- . EN 1717:2000 Protection against pollution of potable water installations and general requirements of devices to prevent pollution by backflow
- DIN6856-3 Radiological film viewing boxes and viewing conditions - Part 3: Radiological film viewing boxes for dentistry
- ISO 6875:2011 Dental patient chair ●
- ISO 9680:2007 Dentistry-Operatinglights ●
- ISO 11143:2008 Dentistry-Amalgam separators
- ISO 13485:2003 with Technical Corrigendum 1:2009 . Medical devices -Quality 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
12
- ISO 21531:2009 Dentistry -- Graphicalsymbols for dental instruments ●
- 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
g CONCLUSION
Based on a comparison of intended use, indication, construction materials, principle of operation, features and technical data, the Sirona INTEGO family is as safe and as effective to perform its intended use and is substantially equivalent to the predicate devices.