YOBOSHI DENTAL UNIT

{0}------------------------------------------------ K103550 Yoboshi Dental Unit- 510(K): Sec. 5 # 510(K) SUMMARY ## JAN - 4 2011 This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR 807.92 #### 1.0 Submitter's Information ## Establishment Registration Name: Foshan Yoboshi Medical Equipment Co., Ltd. 4 Simple Workshop, East city road, (Fuwan) hecheng city street, Gaoming, Foshan, Guangdong China 528500 Contact Person of applicant Mr. Jianjun Zhong - Management Representative ' 4 Simple Workshop, East city road, (Fuwan) hecheng city street, Gaoming, Foshan, Guangdong China 528500 TEL: +86-757-2885 3333 FAX: +86-757-2890 1866 Email: ## Contact Person of the Submission: Ms. Sabrina Wei MEDLAB (Shenzhen) Information Service Co., LTD Room 2706, Block A, ZhongFang JinYuan Buiding, Xinwen Road Shenzhen, Guangdong, P.R. China, 518034 TEL: +86-755-83089699 FAX: +86-755-83089760 Email: sabrinawei(@hotmail.com; ; please CC lingbensuo@gmail.com, #### 2.0 Device Information Type of 510(k) submission: Traditional Device Common Name: · Dental Unit with Chair Trade Name: Yoboshi Dental Unit Model: A8000, A8000-I, A8000-II Classification name: · Dental operative unit and accessories {1}------------------------------------------------ | Review Panel: | Dental | |--------------------|----------| | Product Code: | EIA | | Regulation Class: | I | | Regulation Number: | 872.6640 | #### 3.0 Predicate Device Information | Sponsor: | North West Medical Instrument (Group) Co., Ltd | |----------------|------------------------------------------------| | Device: | Dental Unit with Chair, Model: S2300 | | 510(K) Number: | K080438 | #### 4.0 Device description Yoboshi dental units with chairs are driven by imported low-voltage DC motor with imported air spring auxiliary balance to keep a safe and stable operation of equipment and low noise. With two pieces of NSK high speed H.P and one piece of NSK lowspeed H.P, it is easy and credible for working. The single-form seamless leather cushion provides comfort for the patient to sit and for the doctor to clean and disinfect more easily. It is applicable for the dental clinic. The unit is composed of integral ceramic spittoon, air-controlled balanced instrument-arm, newlydesigned cold light. The models include A8000, A8000-I, A8000-II. All of these types follow the same design principle and intended use, and comply with ISO7494-1:2004, ISO7494-2:2003. The hose connectors of these types comply with ISO9168:1991. The air-motors of these types comply with ISO13294: 1997. Dental patient chair complies with ISO 6875:1995. All of these types of applicant devices consist of similar components with similar function and different appearance, these components include: - Electric pedal switch ● - Control key for mouth lamp - Wash cuspidor - Gargle water control - Pedal switch - Handrail - Backrest - Headrest - Cuspidor - Rising pipe - Lamp arm - Operation light - Seat cushion for child #### Intended Use 5.0 The Dental Unit with Chair is intended to supply power to and serve as a base for {2}------------------------------------------------ dental devices and accessories. It is intended for use in the dental clinic/office environment and used by trained dentists and/or dental technicians and assistants. This product is attached with a dental chair #### 6.0 Effectiveness and Safety Considerations ### Effectiveness: The Dental Unit with Chair complies with ISO7494-1:2004, ISO7494-2:2003, ISO9168: 1991, ISO 6875:1995 and ISO13294: 1997. ### Safety Considerations: The applicant devices comply with IEC60601-1, Medical electrical equipment - Part 1: General requirements for safety and IEC60601-1-2, Medical electrical equipment - Part 1-2: General requirements for safety -Collateral standard: Electromagnetic compatibility - Requirements and tests. For all hose connectors and air motors, the applicant devices comply with ISO 9168: 1991 and ISO 13294: 1997. For dental patient chair, the applicant devices comply with ISO 6875:1995. In regard to biocompatibility evaluation, the applicant devices comply with ISO 111381-1: 2006 for BI material, ISO 11737-1: 2006 for disposable anesthesia channel; ISO 10993-5 & -10 for Single-use anesthesia tube. The Software Validation is in compliance with FDA Guidance for the Content of Pre-Market Submissions for Software Contained in Medical Devices. #### Comparison to predicate device and conclusion 7.0 ### Comparison Analysis The applicant device has same classification information, same indications and intended use, similar product design, similar technical specification, biological specification and safety specification. The video system of the applicant device is optional for Model A8000 & A8000-I, and it is substantially equivalent to the predicate device in other parts. ### Conclusion: The applicant device is Substantially Equivalent (SE) to the predicate device which is US legally marketed device. Therefore, the applicant device is determined as safe and effectiveness. Compare with predicate device, they are very similar in design principle, intended use, functions, material and the adopting applicable standards. The differences between applicant device and predicate device do not raise any new questions of safety or effectiveness. {3}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission of providing essential human services. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MID 20993-0002 Fosham Yoboshi Medical Equipment Company, Limited C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313 JAN - 4 2011 Re: K103550 Trade/Device Name: Yoboshi Dental Unit with Chair Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: December 21, 2010 Received: December 22, 2010 Dear Mr. Job: 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. {4}------------------------------------------------ Page 2- Mr. Job Enclosure 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ ucm 1 1 5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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. Sincerely yours, Susan Russer Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health {5}------------------------------------------------ # Statement of Indications for Use 510(k) Number (if known): K103556 Device Name: Model: Yoboshi Dental Unit with Chair A8000, A8000-I, A8000-II JAN - 4 2011 Indications for Use: The Dental Unit with Chair is intended to supply power to and serve as a base for dental devices and accessories. It is intended for use in the dental clinic/office environment and used by trained dentists and/or dental technicians and assistants. This product is attached with a dental chair Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) is use Stidfer > Division Sign-Off) iivision of Anesthesiology, General Hospital nfection Control, Dental Devices آران وجود اللود والموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الم 510(k) Number: Concurrence of CDRH, Office of Device Evaluation (ODE) Page_1_of_1