SDIF Dental chairs with operative unit is indicated for use to supply power to and serve as a base for dental devices and accessories. This product includes a dental chair. The unit is indicated for use in the dental clinic/office environment used by trained dentists and/or dental technicians and assistants

Device Description

SDIF dental chairs with operative units provide patient comfort and dentists' air and water supplies for dental instruments and procedures. Water pressure: 200~400Kpa. Air water Supplios for dontar mounts can be powered from ~110/220/230V. The chair is protoure. The system is compatible with instruments from various manufacturers with standard fittings.

AI/ML Overview

The provided text is a 510(k) summary for a "SDIF Dental chair with Operative Unit and accessories". It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria.

Specifically, the document states:

"14-Safety and Effectiveness of the device: This device is safe and effective as the other predicate device cited above." This is a claim of substantial equivalence based on the predicate, not a report of a specific study to meet acceptance criteria.
The FDA letter (pages 1-3) confirms the substantial equivalence determination based on the information provided in the 510(k) submission but does not detail the specific performance studies that show the device meets acceptance criteria.

Therefore, I cannot provide the requested table and study details as the information is not present in the provided document. The document is primarily focused on describing the device and its intended use for regulatory clearance, not on detailing a performance study with specific acceptance criteria.

Summary

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K06 3302

NOV 1 5 2006

510(k) Summary As Required by 21 section 807.92 ( c )

SHANGHAI DENTAL INSTRUMENT FACTORY CO., LTD 1-Submitter Name: ("SDIF") 820 LINGSHI ROAD, SHANGHAI CHINA 200072 2-Address: Tel +86 21 66255988. 3-Phone: Fax +86 21 56956197 4-Fax: Ms Chen Yimei, Vice General Manager 5-Contact Person: 5-Consultant: Jay Mansour, Mansour Consulting LLC, 845 Aronson Lake Court, Roswell, GA 30075 USA. Tel 678-908-8180. Fax 678-623-3765 7-Date summary prepared: October 26th, 2006 8-Device Trade or Proprietary Name: SDIF Dental chair with Operative Unit and accessories 9-Device Common or usual name: Dental chair with operative unit 10-Device Classification Name: Chair, Dental, with Operative unit 11-Substantial Equivalency is claimed against the following device: K052470

12-Description of the Device:

13-Intended use of the device:

SDIF dental chairs with Operative Unit is intended for use 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.

14-Safety and Effectiveness of the device:

This device is safe and effective as the other predicate device cited above.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with outstretched wings, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Shanghai Fimet Medical Instrument Company, Limited C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313

NUV 15 2006

Re: K063302

Trade/Device Name: SDIF Dental Chairs with Operative Unit Regulation Number: 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: October 30, 2006 Received: November 1, 2006

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.

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. Job

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions 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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Snite y. Michien M.D.

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

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: SDIF DENTAL CHAIRS WITH OPERATIVE UNIT

Indications For Use:

Prescription Use (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)

Susan Rumer

:
Sign-Off)
en of Anesthesiology, General Hospital,
con Control, Dental Devices

) Fiumber:

Page 1 of 1

PAGE 11

Regulation Number and Section

§ 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.