TAURUS C1

{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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized representation of three human profiles facing to the right, resembling a bird-like shape. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 22, 2016 Shinhung Company, Ltd. c/o Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway Houston, Texas 77025 Re: K151996 Trade/Device Name: Taurus C1 Regulation Number: 21 CFR 872.6640 Regulation Name: Operative Dental Unit and Accessories Regulatory Class: I Product Code: EIA Dated: December 9, 2015 Received: December 15, 2015 ### Dear Mr. Kim: 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. {1}------------------------------------------------ Page 2 - Mr. Dave Kim 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 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 device-related 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 vours. Tina Kiang - 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K151996 Device Name TAURUS C1 Indications for Use (Describe) The TAURUS C1 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 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. Type of Use (Select one or both, as applicable) | <div> <span> <span style="font-size:16px;"></span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | |-------------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="font-size:16px;"></span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # Traditional 510(k) Summary This 510(k) summary is being submitted in accordance with requirements of 21 CFR Part 807.92. Date 510k summary prepared: December 10, 2015 #### I. SUBMITTER | Submitter's Name : | Shinhung Co., Ltd. | |----------------------------------------------------|-----------------------------------------------------------------------------------| | Submitter's HQ Address: | Shinhung Bldg, 450, Cheongpa-ro, Jung-gu,<br>Seoul, 100-858, Korea | | Factory Address: | 42-25, 27beon-gil, Dongsan-ro, Danwon-gu,<br>Ansan-si, Gyeonggi-Do, 425-852 Korea | | Submitter's Telephone: | +82(2)6366-2124 | | Contact person: | Sky Shin( sky@shinhung.co.kr) / Manager | | Official Correspondent:<br>(U.S. Designated agent) | Dave Kim (davekim@mtech-inc.net) | | Address: | 8310 Buffalo Speedway, Houston, TX 77025 | | Telephone: | +713-467-2607 | | Fax: | +713-583-8988 | II. DEVICE | Trade/proprietary name | : | TAURUS C1 | |------------------------|---|---------------------------------------| | Common or Usual Name | : | Dental Chair and Units | | Regulation Name | : | Dental Operative Unit and Accessories | | Regulation Number | : | 21 CFR 872.6640 (Product Code: EIA) | | Regulatory Class | : | I Class | | Prescription Use. | | | {4}------------------------------------------------ #### III. PREDICATE DEVICE | Primary Manufacturer | : | A-DEC, INC | |----------------------|---|-----------------------------------------| | Device Name | : | A-DEC 200 DENTAL SYSTEM | | 510(k) Number | : | K102234 (Decision Date – Jan. 13, 2012) | | Regulation Name | : | Dental Operative Unit and Accessories | | Regulation Number | : | 21 CFR 872.6640 (Product Code: EIA) | | Regulatory Class | : | I Class | Prescription Use This predicate has not been subject to a design-related recall. No reference devices were used in this submission. #### DEVICE DESCRIPTION IV. TAURAUS C1 is a dental chair and units to be used to take for diagnosis and therapy of patients. It consists of the main unit and accessories. The dental chair is used for patient to sit during the dental diagnosis, treatment and /or operation. The dental unit consists of patient chair, dentist table with instrument holders, assistant table, water unit, arm system, cuspidor (spittoon) and dental light. The dental unit system is used by trained dentists and /or dental assistants to supply air, water, vacuum and electrical power to dental devices and accessories to allow the dental practitioner an intuitive control center for all common and normal patient treatment procedures performed in the dental operatory. {5}------------------------------------------------ #### INDICATIONS FOR USE: V. The TAURUS C1 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 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. ### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE VI. DEVICE | | Model | A-dec 200 (K102234) | TAURUS C1 for 510K | | |--------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------| | | Indications for Use | The A-dec 200 Dental<br>System and accessories are<br>intended for use in general<br>dental applications by<br>providing the dental<br>practitioner a user interface<br>to control operation of the<br>dental chair and attached<br>dental devices. The system<br>delivers air, water, vacuum<br>and electricity to allow the<br>dental practitioner an<br>intuitive control center for<br>all common and normal<br>patient treatment procedures<br>performed in the dental<br>operatory | The TAURUS C1 Dental<br>System and accessories are<br>intended for use in general<br>dental applications by<br>providing the dental<br>practitioner a user interface<br>to control operation of the<br>dental chair and attached<br>dental devices. The system<br>delivers air, water, vacuum<br>and electricity to allow the<br>dental practitioner an<br>intuitive control center for<br>all common and normal<br>patient treatment procedures<br>performed in the dental<br>operatory. | | | | Construction | CHAIR / UNIT / DOCTOR<br>TABLE /ASSISTANT<br>TABLE / OPERATING<br>LIGHT / FOOT<br>CONTROLLER / STOOL | CHAIR / UNIT/ DOCTOR<br>TABLE /ASSISTANT<br>TABLE / OPERATING<br>LIGHT / FOOT<br>CONTROLLER / STOOL | | | | Power Supply /<br>Frequency | AC100V/110V/120V,<br>AC210/220/230V , 50/60Hz | AC100V/110V/115V,<br>AC210/220/230V, 50/60Hz | | | | Power<br>Shock<br>Protection | Class 1 | Class 1 | | | | Electric Protection | B Type | B Type | | | | | EN 60601-1-2 | EN 60601-1-2 | | | | EMC Standard | IEC 61000-3-2 | IEC 61000-3-2 | | | | | IEC 61000-3-3 | IEC 61000-3-3 | | | | Dental<br>units<br>Standard | ISO 7494-1<br>ISO 7494-2 | ISO 7494-1<br>ISO 7494-2 | | | | Dental Patient<br>chair Standard | ISO 6875 | ISO 6875 | | | | Safety Standard | EN 60601-1 | EN 60601-1 | | | | Chair Operating<br>system | Hydraulic system | Hydraulic system | | | Description<br>(Comparative<br>testing<br>confirmed<br>equivalence<br>to the noted<br>predicate) | UNIT/CHAIR<br>form type | Over-arm Contour type | Over-arm Contour type | | | | Vacuum system | Central Vacuum system | Central Vacuum system or<br>Air Vacuum system | | | | 3-Way Syringe | Adjusting the Water / Air /<br>Spray function is used in the<br>syringe button. | Adjusting the Water / Air /<br>Spray function is used in the<br>syringe button. | | | | Cuspidor(Spittoon) | Spittoon bowl / Rinsing pipe<br>/ Tumbler filler | Spittoon bowl / Rinsing pipe<br>/ Tumbler filler | | | | Water System | City Water / Distilled Water | City Water / Distilled Water | | | | | Comparative testing<br>confirmed equivalence to<br>the noted predicate | | | | | Light head<br>structure | 3-axis head adjustment<br>method | 3-axis head adjustment<br>method | | | Operating<br>Light | ON/OFF control | Auto and manual ON/OFF | Auto and manual ON/OFF | | | | Headrest | Double-articulating<br>headrest | Double-articulating<br>headrest | | | | Safety switch<br>function | Chair lift arm and auxiliary<br>arm, 2 safety switches | Chair lift arm and auxiliary<br>arm, 2 safety switches | | | | | The safety switch stops the<br>chair operation. | The safety switch stops the<br>chair operation. | | | | | | chair | chair | | | Programmable<br>chair position | Programmable<br>position:<br>Total 4 positions | Programmable<br>position:<br>Total 5 positions | | | Delivery<br>system | Handpiece holder | 5 angle adjustable holders | 6 integrated rotation type<br>holder | | | | | Handl e | Adjustable handle | Fixed handle | | | | Touchpad | Membrane panel | Membrane Panel | | | | Handpiece water<br>and air cooling | Manually adjustable<br>handpiece water / air cooling | Manually adjustable<br>handpiece water / air cooling | | | | Flexarm tension | Control the tension to adjust<br>the shift of flexarm rotation<br>flow. | Control the tention to adjust<br>the shift of TABLE ARM<br>rotation. | | Accessories<br>tools | Accessories holder | HVE, SE, 3-WAY syringe<br>attached | HVE, SE, 3-WAYsyringe<br>attached | | | | | Holder structure | Rotation and individual<br>holder | Fixed, one-piece holder | | Support<br>center | Cuspidor | Self-contained 2 liter water<br>bottle system | Attach/detachable GLASS,<br>disassemble for cleaning | | | | | Sol i ds c ol lec tor | Equipped | Equipped | | | | Distilled water<br>reservoir | Equipped | Equipped | | | | Cup water system | Manual water system<br>Press the cupfill button for a<br>timed operation. Press and<br>hold the cupfill button for<br>manual operation. | Automatic and manual water<br>system.<br>Place the cup at the specified<br>location for a timed<br>operation. | | Accessories<br>attached to<br>the device: | handpiece / Low speed handpiece / Scaler / Curing light / Dental Chair / 3-way<br>syringe | | | | | Operation<br>Method | Control panel / Assistant control panel / Foot controller | | | | {6}------------------------------------------------ {7}------------------------------------------------ #### VII. PERFORMANCE DATA The following performance data was provided in support of the substantial equivalence determination. Biocompatibility testing: TAURUS C1 dental operative unit and accessories use the materials already cleared for patient contact components such as patient chair seat, arm rest, 3 way syringe, {8}------------------------------------------------ vacuum syringe, and saliva ejector which are similar to the predicate device. ## Non Clinical testing: IEC 60601-1 Test for Medical Electrical Equipment was performed for General Requirements for basic safety and essential performance. The requirements of specified standards were fulfilled. IEC 60601-1-2 Test for Medical Electrical Equipment was performed for General Requirements for basic safety and essential performance (collateral standards: electromagnetic compatibility. The requirements of specified standards were fulfilled. ISO 7494-1 Test was performed for general requirements and test methods: Pass ISO 7494-2 Test was performed for general requirements for water and air supply: Pass ISo6875 test was performed for general, electrical, and mechanical requirements: Pass # VIII. CONCLUSIONS There are no significant differences between the TAURUS C1 and the predicate device. In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification Shinhung Co, Ltd. concludes that TAURUS C1 is substantially equivalent in comparison with Adec-200, the predicate device as described herein.