INTEGO Family and Accesories

K150909 · Sirona Dental Systems GmbH · EIA · Jul 17, 2015 · Dental

Device Facts

• Record ID: K150909
• Device Name: INTEGO Family and Accesories
• Applicant: Sirona Dental Systems GmbH
• Product Code: EIA · Dental
• Decision Date: Jul 17, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1

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 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.

Device Story

The INTEGO Family is a dental treatment unit system comprising a patient chair, dentist/assistant elements, foot control, and water unit. It serves as a base for dental instruments, supplying power, air, and water. The MOTOR BL ISO E drives rotating/oscillating handpieces for endodontic and general procedures. The SPRAYVIT E syringe provides unheated air/water and illumination. Used in dental clinics by dentists/assistants. The system features ergonomic design, smooth surfaces for infection control, and hands-free operation via foot control. It replaces the C8+ unit, maintaining similar functional principles. The device improves workflow and ergonomics, facilitating patient treatment through integrated controls and modular accessories.

Clinical Evidence

No clinical data. The submission relies on bench testing, literature review, and critical appraisal by medical professionals. Compliance with performance standards (ISO 7494-1/2, ISO 10993, IEC 60601-1, etc.) and comparison to predicate devices demonstrate safety and effectiveness.

Technological Characteristics

Dental operative unit with patient chair, dentist/assistant elements, and water unit. Materials selected for chemical disinfectant resistance (ISO 21530). Features include electric motors (BL ISO E), LED lighting, and integrated USB/network interfaces. Software is classified as moderate level of concern. Sterilization/disinfection via detachable parts, barriers, and automated waterline sanitization (Dentosept P). Complies with IEC 60601-1, IEC 62304, and ISO 14971.

Indications for Use

Indicated for use in dental clinics by trained dentists or dental assistants to provide a base and power for dental devices, including handpiece operation (endodontic/general) and irrigation/illumination via multifunctional syringe. Contraindicated for use in explosive hazard areas, mobile vehicles, or for patients with specific pulmonary diseases or high immunosuppression (unless using sterile solutions).

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)

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" 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

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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,

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

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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)

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# 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: [phone]

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

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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

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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.

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#### 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+<br>(K032543) | A-DEC 200<br>(K102234) | INTEGO Family |
|-------------------|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Intended<br>Use | The CS+ Dental<br>Operative Unit<br>with accessories is<br>intended to supply<br>power to and serve<br>as<br>a base for dental<br>devices and<br>accessories.<br>This product<br>includes a dental<br>chair. The 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-Dec200 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. | The INTEGO Family of Dental<br>Operative Units with accessories<br>is intended to supply power to<br>and serve as a base for dental<br>devices and accessories. Each<br>unit includes a dental chair. The<br>units are intended for use in the<br>dental clinic environment and<br>are used by trained dentists<br>and/or dental assistants. |
| | Positions | 5 instrument<br>positions | 5 instruments<br>positions | 5 instrument positions + 1<br>Additional |
| Dentist Element | Max. Motors | Up to 2 motors | Up to 3 motors | Up to 2 drill drives |
| | User<br>Interface | TouchPad (No<br>display) | Touch Pad only with<br>buttons | Touchpad (EasyPad) with 7-<br>segment display |
| | | | | Touch display (EasyTouch)<br>Display |
| | Device | C8+<br>(K032543) | A-DEC 200<br>(K102234) | INTEGO Family |
| | | handsfree<br>operation by<br>foot control | handsfree operation<br>by foot control | Handsfree operation with cursor<br>control (with EasyTouch)<br>4.3" (optional) |
| | Syringe | 3-way syringe<br>/ Sprayvit | 3 way | 3 way syringe / Sprayvit E with light |
| | Turbines | Turbines | Turbines | Turbines with light |
| | Motors | Motor SL<br>(electric<br>motor) | . | Motor BL ISO E (electric motor with<br>light) |
| | | Motor SL ISO<br>(electric<br>motor) | . | . |
| | Control of<br>coolant | Water amount<br>controlled by<br>the unit | Manual knob to open<br>or close for water | Water amount controlled by the unit |
| | | Air amount<br>controlled by<br>the unit | Manual knob to open<br>or close for air | Air amount controlled by the unit |
| | Scaler | Sirosonic L<br>with light | yes | Sirosonic L with light |
| | Intraoral<br>Camera | Sirocam 3 | . | Sirocam F / Sirocam AF |
| | Curing light | Mini LED<br>(Acteon<br>Satelec) | . | Mini LED (Acteon, Satelec) |
| | X-ray<br>Viewer | X-ray viewer | X-ray image viewer | X-ray image viewer |
| | Style of<br>dentist<br>element | Height<br>adjustable<br>support arm<br>(CS, TS) | Adjustable arm with<br>manual knob | Height adjustable support arm with<br>pneumatic brake |
| | | Cart version | . | |
| | | swivel arms or<br>hanging hoses | hanging hoses | swivel arms or hanging hoses (CS /<br>TS) |
| | | Additional tray | tray only on the | Additional tray at dentist element |
| | Device | C8+<br>(K032543) | A-DEC 200<br>(K102234) | INTEGO Family |
| Assistant Element | | at dentist<br>element | dentist element | |
| | Endodontics | . | . | Torque control kit |
| | Interfaces | . | . | USB interface |
| | Positions | 3 handpiece<br>positions | 3 handpiece positions | 4 handpiece positions |
| | User<br>Interface | Touch pad | Touch pad | Touch pad |
| | Syringe | 3-way syringe<br>/ Sprayvit | 3-way syringe | 3 way syringe / Sprayvit E with light |
| | Curing light | Mini LED<br>(Acteon<br>Satelec) | . | Mini LED |
| | Suction | Suction devices | Suction devices | Suction devices |
| | | Saliva ejector | Saliva ejector | Saliva ejector |
| Chair | | | HVE (High<br>volume<br>evacuator) | HVE (High volume<br>evacuator) |
| | Interfaces | . | . | USB interface |
| | | Hydrocolloid<br>port | . | Hydrocolloid port |
| | Patient load | Max. 135kg + 5<br>kg accessories | 181 kg | Max. 135kg + 5 kg accessories / Max.<br>180kg + 5 kg accessories (optional) |
| | Headrest | Flat headrest | double-articulating<br>headrest | Flat headrest |
| | | Articulating<br>headrest | . | Double articulated headrest |
| | Upholstery | Standard/lounge<br>upholstery<br>(sleek style) | Upholstery Care<br>(sleek style) | Thermo upholstery (sleek style) |
| | Arm Rest | Arm rest | Arm rest | Arm rest |
| | Switch | 4-way foot-<br>switch | . | 4-ay foot-switch |

July 16, 2015

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| | Device | C8+<br>(K032543) | A-DEC 200<br>(K102234) | INTEGO Family |
|------------|-------------------------------------------|-------------------------------------------------------------------|------------------------------------------|---------------------------------------------------------|
| | Movement | Synchronized<br>Backrest and<br>seat<br>movements | . | Synchronized Backrest and seat<br>movements |
| | | . | . | External device connection |
| | | . | . | Pressure reduction kit |
| | | User<br>programmable<br>positions | User programmable<br>positions | User programmable positions |
| | | Backrest<br>motor driven | Backrest motor<br>driven | Backrest motor driven |
| | | Seat motor<br>driven | Seat motor driven | Seat motor driven |
| | Cuspidor<br>bowl | Cuspidor bowl | Cuspidor | Cuspidor bowl |
| | Amalgam<br>separator | Amalgam<br>separator | Amalgam separator | Amalgam separator |
| | Water | Fresh water<br>bottle/<br>Connection to<br>municipal<br>water | Fresh water bottle | Fresh water bottle / Connection to<br>municipal water |
| Water unit | Heating | Water heater | . | Water heater |
| | Water /<br>Suction<br>hose treat-<br>ment | Water<br>treatment with<br>continuous<br>sanitization<br>function | Put tablets in the<br>water 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<br>flushing with<br>water | only by flushing with<br>water | Suction hose cleaning with<br>chemicals |
| | Water<br>treatment | Dentosept P<br>Waterline<br>Treatment | A-dec ICX Waterline<br>Treatment tablets | Dentosept P Waterline Treatment<br>solution |

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| | 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<br>Light | LEDview<br>Sirolux E | LED light | LEDview<br>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<br>Electronic foot control | Foot Switch<br>Foot Control | Pneumatic Foot control available<br>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)

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- 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

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- 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.