F1 SERIES DENTAL CHAIRS WITH OPERATIVE UNIT

K052470 · Shanghai Fimet Medical Instrument Co., Ltd. · EIA · Nov 1, 2005 · Dental

Device Facts

• Record ID: K052470
• Device Name: F1 SERIES DENTAL CHAIRS WITH OPERATIVE UNIT
• Applicant: Shanghai Fimet Medical Instrument Co., Ltd.
• Product Code: EIA · Dental
• Decision Date: Nov 1, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1

Intended Use

The FI Series Dental Chairs with Operative Unit is intended to supply power to and serve as a base for dental devices and accessories. This product includes a dental chair. The unit is intended for use in the dental clinic/office environment and used by trained dentists and/or dental technicians and assistants.

Device Story

F1 Series Dental Chairs with Operative Unit provide patient support and utility supply for dental procedures. System includes motorized chair, dentist instrument board, cuspidor, assistant board, dental light, and footswitches. Operates via electrical power (~110/220/230V) to provide air (600~800Kpa) and water (200~400Kpa) to compatible dental instruments (e.g., turbines, scalers, motors). Used in dental clinics by trained professionals to facilitate patient positioning and instrument operation. Enhances clinical workflow by centralizing power and utility delivery for various dental accessories.

Clinical Evidence

No clinical data. Substantial equivalence based on bench testing and feature comparison.

Technological Characteristics

Motorized dental chair with integrated operative unit. Power: 110/220/230V AC. Air pressure: 600-800Kpa; Water pressure: 200-400Kpa. Components: dentist instrument board, cuspidor, assistant board, dental light, footswitches. Compatible with standard dental instrument fittings. Safety standard: UL 60601-1.

Indications for Use

Indicated for use in dental clinic/office environments by trained dentists, dental technicians, and assistants to serve as a base and power supply for dental devices and accessories.

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

• Sirona Dental Systems C8+ (K032543)

Submission Summary (Full Text)

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# EXHIBIT 2 510(k) Summary

## Shanghai Fimet Medical Instrument Co., Ltd. 961 Kangqiao Road, Pudong, Shanghai 201315 China Tel: [phone] Fax: [phone] E-mail: [e-mail] Contact: Simo Makkonen, General Manager October 26, 2005

- 1. Identification of the Device: Proprietary-Trade Name: F1 Series Dental Chairs with Operative Unit Classification Name: Unit, operative dental Product Code EIA Common/Usual Name: Dental operative unit and accessories
- 2. Equivalent legally marketed device: Sirona Dental Systems C8+ , K032543 .
- Indications for Use (intended use): The FI Series Dental Chairs with Operative Unit is 3. intended to supply power to and serve as a base for dental devices and accessories. This product includes a dental chair. The unit is intended for use in the dental clinic/office environment and used by trained dentists and/or dental technicians and assistants.
- 4. Description of the Device: F1 Series Dental Chairs with Operative Units provide patient comfort and dentists' air and water supplies for dental instruments and procedures. Water pressure: 200~400Kpa. Air pressure: 600~800Kpa. The units can be powered from ~110/220/230V. The chair is motorized. The system is compatible with instruments from various manufacturers with standard fittings.

Image /page/0/Picture/8 description: The image shows a dental chair and equipment. The chair is dark and has a headrest and armrests. The equipment includes a light, a water supply, and a suction device. The equipment is all white and is mounted on a stand. The image is black and white and is slightly grainy.

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- 5. Safety and Effectiveness, comparison to predicate device:
.

| Comparison Areas | Sirona Dental Systems C8+, K032543 | Shanghai Fimet F1 Series Dental Chairs with Operative Unit |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| Indications for use | Intended to supply power to and serve as a base for dental devices and accessories. This product includes a dental chair. The unit is intended for use in the dental clinic/office environment and used by trained dentists and/or dental technicians and assistants. | SAME |
| Power | 100/120/240 ac | SAME |
| Components | Chair, dentist instrument board, cuspidor, assistants board, dental light, footswitches | SAME |
| Compatibility | Air water syringe, high and low speed turbines, electric motors, ultrasonic scalers, fiber optic instruments, dental curing light, water warmer, airscaler, air polisher | SAME |
| Safety Standards | Not specified | UL Standard for Safety, Medical Devices, UL 60601-1 |

- 6. Conclusion: In all important respects, the F1 Series Dental Chairs with Operative Units are substantially equivalent to the Sirona Dental Systems C8+ , K032543. This conclusion is based on indications for use, feature comparisons, and safety standards testing.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

### Public Health Service

NOV - 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Shanghai Fimet Medical Instrument Company Limited C/O Mr. Daniel Kamm Regulatory Engineer Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015

Re: K052470

Trade/Device Name: F1 Series Dental Chairs with Operative Unit Regulation Number: 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: September 6, 2005 Received: September 12, 2005

Dear Mr. Kamm:

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. Kamm

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 vours,

Sophie y. Michael MD.

Chu 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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K052470

## Indications for Use

510(k) Number (if known):

Device Name: ________ F1 Series Dental Chairs with Operative Unit

Indications For Use:

The F I Series Dental Chairs with Operative Unit is intended to supply power to and serve as a base for dental devices and accessories. This product includes a dental chair. The unit is intended for use in the dental clinic/office environment and used by trained dentists and/or dental to thicials and assistants.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)


| Division Sign-Off | |
|-----------------------------------------------|---------|
| Division of Anesthesiology, General Hospital, | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K052470 |

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