DENTAL UNIT WITH CHAIR

K080438 · North West Medical Instrument (Group) Co., Ltd. · EIA · Apr 4, 2008 · Dental

Device Facts

• Record ID: K080438
• Device Name: DENTAL UNIT WITH CHAIR
• Applicant: North West Medical Instrument (Group) Co., Ltd.
• Product Code: EIA · Dental
• Decision Date: Apr 4, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1
• Attributes: 3rd-Party Reviewed

Intended 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.

Device Story

Dental unit with integrated chair; provides power and mounting base for dental instruments/accessories. Components include main box, connection box, assistant holder, foot control, telescopic tray arm, instrument tray, and operating light. Used in dental clinics by dentists, technicians, and assistants. Operates as a support platform for clinical dental procedures. Benefits include organized, powered workspace for dental equipment.

Clinical Evidence

Bench testing only. Compliance with ISO 7494-1, ISO 7494-2, ISO 6875, ISO 9168, ISO 10993 (biocompatibility), IEC 60601-1 (safety), and IEC 60601-1-2 (EMC). Software validation performed per FDA guidance.

Technological Characteristics

Dental operative unit; includes main/connection boxes, tray arms, foot control, and light. Complies with ISO 7494-1/2, ISO 6875, ISO 9168. Biocompatibility per ISO 10993. Electrical safety per IEC 60601-1; EMC per IEC 60601-1-2.

Indications for Use

Indicated for use in dental clinics/offices by trained dentists, dental technicians, and assistants to provide power and a base 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

• C8+DENTAL OPERATIVE UNIT (K032543)

Submission Summary (Full Text)

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K080438

# 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 9807.92.

The Assigned 510(k) Number is:

## 1. Applicant Device Information

Trade/Proprietary Name: Dental Unit with Chair Model: S2300, S2305, S2308, S2315, S2318, S2320 Common Name: Dental Unit with Chair Classification Name: Unit, Operative Dental Device Class: I Product Code: EIA Regulation Number: 872.6640 Review Panel: Dental Intended 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.

### 2. Submitter Information

## Sponsor and Manufacturer:

North West Medical Instrument (Group) Co., Ltd No.3 Biyuan Road, Xianyang, 712000 Shaanxi, China

#### Contact Person of the Submission:

Ms. Diana Hong Mr. Eric Chen Shanghai Mid-Link Business Consulting Co., Ltd Suite 8D, Zhongxin Zhongshan Mansion, No.19, Lane 999, Zhong Shan Nan Er Road, 200230 Shanghai, China Phone: [phone] x 152 Fax: [phone] x 809

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#### Email: [e-mail]

## 3. Predicate Device

K Number: K032543 C8+DENTAL OPERATIVE UNIT Classification Name: Unit, Operative Dental Product Code: EIA Manufacturer: SIRONA DENTAL SYSTEMS GMBH.

### 4. Device Description

The applicant device of Dental Unit with Chair contains 6 types: S2300, S2305, S2308, S2315, S2318 and S2320. All of these types follow the same design principle and intended use, and comply with ISO7494-1, ISO7494-2 and ISO6875. The connection of these types complies with ISO9168.

All of these types of applicant device consist of similar components with similar function and different appearance, these components include: main box, connection box, assistant holder, foot control, telescopic tray arm, instrument tray, operating light.

### 5. Effectiveness and Safety Considerations

#### Effectiveness:

The Dental Unit with Chair comply with ISO7494-1, ISO7494-2, ISO6875 and ISO9168.

#### Safety Considerations:

The Biological Evaluation Tests are in compliance with the standards of ISO 10993, "Biological Evaluation of Medical Devices". The compatibility of the skin-contact component material in the finished product meets the requirement of Biocompatibility.

The applicant device is compliance 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

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The Software Validation is in compliance with FDA Guidance to Compliance with FDA Guidance for the Content of PreMarket Submissions for Software Contained in Medical Devices.

## 6. Substantially Equivalence Determination

#### 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 applicant device doesn't provide the video system, but 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 market device. Therefore, the applicant device is determined as safe and effectiveness.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

North West Medical Instrument (Group) Company, Limited C/O Ms. Laura Danielson Responsible Third Party Official TUV SUD America, Incorporated 1775 Old Highway 8NW New Brighton, Minnesota 55112

APR - 4 2008

Re: K080438

Trade/Device Name: Dental Unit with Chair Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: March 20, 2008 Received: March 21, 2008

Dear Ms. Danielson:

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 - Ms. Danielson

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 Quong

Chiu 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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# Y.Indications for Use

510(k) Number: KOSO438 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Device Name: Dental Unit with Chair

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Russo

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

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510(k) Number: K080438