FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C

K071353 · Shanghai Foshion Medical Instruments Co., Ltd. · KLC · Dec 14, 2007 · Dental

Device Facts

• Record ID: K071353
• Device Name: FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C
• Applicant: Shanghai Foshion Medical Instruments Co., Ltd.
• Product Code: KLC · Dental
• Decision Date: Dec 14, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6250
• Device Class: Class 1

Intended Use

The Foshion Chair Mounted Dental Unit is intended to supply power and serve as a base for dental devices and accessories. The product includes a dental chair, operating light, x-ray viewer, control panel, low and high speed turbine hand pieces, 3-way syringe and air foot control. The unit is intended for use in the dental office or clinic and is used by trained dentists and/or dental technicians and assistants.

Device Story

Foshion Chair Mounted Dental Unit serves as a base for dental instruments; provides power to accessories. Components include adjustable dental chair (headrest, backrest, seat, armrests), operating light, x-ray viewer, cuspidor, cup filler, control panel, instrument tray, and foot control. Integrated instruments include 3-way syringe, saliva ejector, air suction, and high/low-speed turbine handpieces. Used in dental offices/clinics by dentists, technicians, and assistants. Device supports patient positioning and instrument operation during dental procedures.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Chair-mounted dental unit; includes mechanical chair adjustments, pneumatic/electric power supply for handpieces, and integrated dental accessories. No specific materials or software algorithms described.

Indications for Use

Indicated for use in dental offices or clinics by trained dentists, dental technicians, and assistants to provide a base and power supply for dental accessories and instruments.

Regulatory Classification

Identification

A dental chair and accessories is a device, usually AC-powered, in which a patient sits. The device is intended to properly position a patient to perform dental procedures. A dental operative unit may be attached.

Predicate Devices

• F1 Series Dental Chairs with Operative Unit (K052470)

Submission Summary (Full Text)

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Ko71353

Traditional 510(k)

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## SECTION 5. 510(K) SUMMARY

| Submission<br>Correspondent: | Keystone Regulatory Services, LLC<br>342 E. Main Street<br>Suite 211<br>Leola, PA 17557<br>USA | DEC 1 4 2007 |
|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| | Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail]<br>Contact: William G. McLain<br>President and Principal Consultant | |
| Submission Sponsor: | Shanghai Foshion Medical Instrument Company, Ltd<br>No.211 Jiangchang No.3 Rd<br>Zhabei Borough<br>Shanghai, China | |
| | Phone: [phone]<br>Fax: [phone] | |
| Date summary prepared: | May 15, 2007 | |
| Device trade name: | Foshion Chair Mounted Dental Unit | |
| Device common name: | Dental chair with operative unit. | |
| Device classification name: | EIA, Dental Operative Unit, 21 CFR 872.6640 | |
| Legally marketed device to<br>which the device is<br>substantially equivalent: | F1 Series Dental Chairs with Operative Unit, K052470. Manufactured by<br>Shanghai Fimet Medical Instrument Co., Ltd. | |
| Description of the device: | The Foshion Chair Mounted Dental Unit is a dental operative unit attached<br>to a dental chair. There are three main parts to the product: a dental chair,<br>a dental unit, and a stool for the dentist. The dental chair has adjustable<br>headrest, backrest, seat with extension for leg support, and armrests. The<br>dental unit consists of a floor box to which are attached a number of<br>operative units: light, x-ray viewer, cuspidor, cup filling device, control<br>panel, instrument tray, and foot control. The instrument panel also includes<br>a 3-way syringe, saliva ejector, air suction, and handpiece attachments | |
| Intended use of the device: | The Foshion Chair Mounted Dental Unit is intended to supply power and<br>serve as a base for dental devices and accessories. The product includes<br>a dental chair, operating light, x-ray viewer, control panel, low and high<br>speed turbine hand pieces, 3-way syringe and air foot control. The unit is<br>intended for use in the dental office or clinic and is used by trained dentists<br>and/or dental technicians and assistants. | |
| Technological<br>characteristics: | The technological characteristics between the predicate and proposed<br>device are similar. Both are chair mounted dental units which supply<br>power and serve as a base for dental devices and accessories. | |
| Conclusions: | There are no significant differences between the Foshion Chair Mounted<br>Dental Unit and the predicate device; therefore, the proposed device does<br>not raise any questions regarding safety and effectiveness. | |
| | The Foshion Chair Mounted Dental Unit, as designed, is as safe and<br>effective as the predicate device. Comparisons have been made to a<br>legally marketed predicate device, and the device is determined to be<br>substantially equivalent to the referenced predicate device currently on the<br>market. | |

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DEC 1 4 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Keystone Regulatory Services, LLC C/O Mr. William Mclain Principal Consultant Shanghai Foshion Medical Instruments Company, Limited 342 East Main Street, Suite 211 No. 3 Road Leola, Pennsylvania 17540

Re: K071353

Trade/Device Name: Chair Mounted Dental Unit Regulation Number: 872.6250 Regulation Name: Dental Chair and Accessories Regulatory Class: II Product Code: KLC Dated: November 28, 2007 Received: December 6, 2007

Dear Mr. Mclain:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Mr. Mclain

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Susan Kummer

×19Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## SECTION 4. INDICATIONS FOR USE STATEMENT

510(k) Number:

Device Name:

Indications for Use:

7135

Chair Mounted Dental Unit

The Foshion Chair Mounted Dental Unit is intended to supply power and serve as a base for dental devices and accessories. The product includes a dental chair, operating light, x-ray viewer, control panel, low and high speed turbine hand pieces, 3-way syringe and air foot control. The unit is intended for use in the dental office or clinic and is used by trained dentists and/or dental technicians and assistants.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OF?

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Suxr June

071353