(105 days)
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.
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.
The provided text is a 510(k) Summary for the Sirona Dental Systems INTEGO Family and Accessories. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with acceptance criteria and device performance in the way a clinical study for a novel device would.
Therefore, many of the requested elements (like sample size, number of experts, adjudication method, MRMC studies, standalone performance with metrics like AUC, sensitivity, specificity, ground truth type for test/training sets) are not applicable in this regulatory context, as it's a submission for a Class I device based on substantial equivalence, not a new high-risk device requiring extensive clinical validation.
However, I can extract information related to the device's adherence to relevant standards and its demonstrated equivalence.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the device's compliance with various national and international standards. The "Reported Device Performance" is stated by the manufacturer to be substantially equivalent to the predicate devices and compliant with these standards. Since this is a substantial equivalence submission, specific numerical performance metrics (e.g., sensitivity, specificity, accuracy) are not provided in the document for the device itself against a specific acceptance criterion.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Compliance with ISO 7494-1 (Dental units - General requirements) | Device complies with ISO 7494-1:2011 |
| Compliance with ISO 7494-2 (Dental units - Water and air supply) | Device complies with ISO 7494-2:2003 |
| Compliance with ANSI/AAMI ES60601-1 (Electrical equipment safety) | Device complies with ANSI/AAMI ES60601-1:2005/(R)2012 and amendments |
| Compliance with IEC 60601-1-2 (EMC) | Device complies with IEC 60601-1-2 Ed 3:2007 |
| Compliance with IEC 60601-1-6 (Usability) | Device complies with IEC 60601-1-6 Ed 3.0 2010 |
| Compliance with IEC 62304 (Software lifecycle processes) | Device complies with IEC 62304:2006 (for moderate concern software) |
| Compliance with IEC 62366 (Usability engineering) | Device complies with IEC 62366 Ed 1.1 2014 |
| Compliance with IEC 62471 (Photobiological safety) | Device complies with IEC 62471:2006 |
| Compliance with ISO 14457 (Handpieces and Motors) | Device complies with ISO 14457:2012 |
| Compliance with ISO 7405 (Biocompatibility) | Device complies with ISO 7405:2008 |
| Compliance with ISO 15223-1 (Medical Device Symbols) | Device complies with ISO 15223-1:2012 |
| Compliance with ISO 10993-10 (Irritation and Skin Sensitization) | Device complies with ISO 10993-10:2010 |
| Compliance with EN 1717 (Protection against water pollution) | Device complies with EN 1717:2000 |
| Compliance with DIN 6856-3 (Radiological film viewing boxes) | Device complies with DIN 6856-3 |
| Compliance with ISO 6875 (Dental patient chair) | Device complies with ISO 6875:2011 |
| Compliance with ISO 9680 (Dentistry - Operating lights) | Device complies with ISO 9680:2007 |
| Compliance with ISO 11143 (Amalgam separators) | Device complies with ISO 11143:2008 |
| Compliance with ISO 13485 (Quality management systems) | Device complies with ISO 13485:2003 |
| Compliance with ISO 21530 (Resistance to chemical disinfectants) | Device complies with ISO 21530:2004 |
| Compliance with IEC 80601-2-60 (Dental equipment) | Device complies with IEC 80601-2-60:2012 |
| Compliance with ISO 17664 (Sterilization of medical devices) | Device complies with ISO 17664:2004 |
| Compliance with ISO 21531 (Graphical symbols for dental instruments) | Device complies with ISO 21531:2009 |
| Compliance with ISO 3964 (Dental handpieces – Coupling dimensions) | Device complies with ISO 3964:1982 |
| Compliance with DIN EN ISO 10993-5 (In vitro cytotoxicity) | Device complies with DIN EN ISO 10993-5:2009 |
| Substantial Equivalence to Predicates | "Sirona INTEGO family is as safe and as effective to perform its intended use and is substantially equivalent to the predicate devices." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Applicable. This document describes a 510(k) submission for a Class I dental operative unit, not a device requiring clinical performance testing with test sets in the typical sense (e.g., for diagnostic accuracy). The evaluation is primarily based on compliance with recognized consensus standards and comparison of technological characteristics to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. See point 2. The evaluation relied on "an evaluation using relevant literature and a critical appraisal of the Dental Treatment Unit and accessories by a medical professional." The number and specific qualifications of this medical professional are not detailed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. See point 2.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is not an AI/CADe/CADx device. No MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithmic device in the AI sense.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable in the traditional clinical validation sense. The "ground truth" for this type of submission is the established performance and safety demonstrated by predicate devices and the requirements set forth in the referenced consensus standards.
8. The sample size for the training set
- Not Applicable. This is not an AI/machine learning device that uses a "training set."
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
{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 | |
|---|---|---|---|---|
| IntendedUse | The CS+ DentalOperative Unitwith accessories isintended to supplypower to and serveasa base for dentaldevices andaccessories.This productincludes a dentalchair. The unit isintended for use inthe dental clinicenvironment andused by traineddentists and/ ordentaltechnicians andassistants. | The A-Dec200 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. | The INTEGO Family of DentalOperative Units with accessoriesis intended to supply power toand serve as a base for dentaldevices and accessories. Eachunit includes a dental chair. Theunits are intended for use in thedental clinic environment andare used by trained dentistsand/or dental assistants. | |
| Positions | 5 instrumentpositions | 5 instrumentspositions | 5 instrument positions + 1Additional | |
| Dentist Element | Max. Motors | Up to 2 motors | Up to 3 motors | Up to 2 drill drives |
| UserInterface | TouchPad (Nodisplay) | Touch Pad only withbuttons | Touchpad (EasyPad) with 7-segment display | |
| Touch display (EasyTouch)Display | ||||
| Device | C8+(K032543) | A-DEC 200(K102234) | INTEGO Family | |
| handsfreeoperation byfoot control | handsfree operationby foot control | Handsfree operation with cursorcontrol (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(electricmotor) | . | Motor BL ISO E (electric motor withlight) | |
| Motor SL ISO(electricmotor) | . | . | ||
| Control ofcoolant | Water amountcontrolled bythe unit | Manual knob to openor close for water | Water amount controlled by the unit | |
| Air amountcontrolled bythe unit | Manual knob to openor close for air | Air amount controlled by the unit | ||
| Scaler | Sirosonic Lwith light | yes | Sirosonic L with light | |
| IntraoralCamera | Sirocam 3 | . | Sirocam F / Sirocam AF | |
| Curing light | Mini LED(ActeonSatelec) | . | Mini LED (Acteon, Satelec) | |
| X-rayViewer | X-ray viewer | X-ray image viewer | X-ray image viewer | |
| Style ofdentistelement | Heightadjustablesupport arm(CS, TS) | Adjustable arm withmanual knob | Height adjustable support arm withpneumatic brake | |
| Cart version | . | |||
| swivel arms orhanging 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 dentistelement | dentist element | ||
| Endodontics | . | . | Torque control kit | |
| Interfaces | . | . | USB interface | |
| Positions | 3 handpiecepositions | 3 handpiece positions | 4 handpiece positions | |
| UserInterface | 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(ActeonSatelec) | . | Mini LED | |
| Suction | Suction devices | Suction devices | Suction devices | |
| Saliva ejector | Saliva ejector | Saliva ejector | ||
| Chair | HVE (Highvolumeevacuator) | HVE (High volumeevacuator) | ||
| Interfaces | . | . | USB interface | |
| Hydrocolloidport | . | Hydrocolloid port | ||
| Patient load | Max. 135kg + 5kg accessories | 181 kg | Max. 135kg + 5 kg accessories / Max.180kg + 5 kg accessories (optional) | |
| Headrest | Flat headrest | double-articulatingheadrest | Flat headrest | |
| Articulatingheadrest | . | Double articulated headrest | ||
| Upholstery | Standard/loungeupholstery(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 | SynchronizedBackrest andseatmovements | . | Synchronized Backrest and seatmovements | |
| . | . | External device connection | ||
| . | . | Pressure reduction kit | ||
| Userprogrammablepositions | User programmablepositions | User programmable positions | ||
| Backrestmotor driven | Backrest motordriven | Backrest motor driven | ||
| Seat motordriven | Seat motor driven | Seat motor driven | ||
| Cuspidorbowl | Cuspidor bowl | Cuspidor | Cuspidor bowl | |
| Amalgamseparator | Amalgamseparator | Amalgam separator | Amalgam separator | |
| Water | Fresh waterbottle/Connection tomunicipalwater | Fresh water bottle | Fresh water bottle / Connection tomunicipal water | |
| Water unit | Heating | Water heater | . | Water heater |
| Water /Suctionhose treat-ment | Watertreatment withcontinuoussanitizationfunction | Put tablets in thewater bottle | Water treatment with permanentsanitization function | |
| Suction hosecleaning withwater | Suction hose cleaningwith water | Suction hose cleaning with water | ||
| only byflushing withwater | only by flushing withwater | Suction hose cleaning withchemicals | ||
| Watertreatment | Dentosept PWaterlineTreatment | A-dec ICX WaterlineTreatment tablets | Dentosept P Waterline Treatmentsolution |
{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 | |
| OperatingLight | LEDviewSirolux E | LED light | LEDviewLEDlight | |
| Monitor | 22" monitor on the light support column | 22" monitor (with integrated power supply) on light support column | ||
| Foot Control | Pneumatic Foot control availableElectronic foot control | Foot SwitchFoot Control | Pneumatic Foot control availableElectronic 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.
§ 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.