BELMONT QUOLIS 5000 SERIES DENTAL UNIT

K072273 · Takara Belmont USA, Inc. · NRD · Dec 20, 2007 · Dental

Device Facts

• Record ID: K072273
• Device Name: BELMONT QUOLIS 5000 SERIES DENTAL UNIT
• Applicant: Takara Belmont USA, Inc.
• Product Code: NRD · Dental
• Decision Date: Dec 20, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1

Intended Use

Dental Unit and Accessories are intended for the Dentists, Hygienists, and Dental Assistants for traditional and normal patient treatment procedures in the dental laboratory.

Device Story

The Belmont Quolis 5000 Series is a dental operative unit and accessory system used in dental clinics. It provides a platform for patient positioning and support during routine dental procedures. Operated by dentists, hygienists, and dental assistants, the device facilitates the delivery of care by organizing necessary dental instruments and positioning the patient for treatment. It functions as a mechanical support and delivery station for dental tools. The device benefits patients by enabling efficient, ergonomic, and stable access for dental professionals during clinical examinations and treatments.

Clinical Evidence

Bench testing only. The device complies with international performance standards including IEC 60601-1, ISO-7494-1:2004, and ISO-7494-2:2003.

Technological Characteristics

Dental operative unit and accessories. Complies with IEC 60601-1, ISO-7494-1:2004, and ISO-7494-2:2003. Mechanical positioning and instrument delivery system. No software or electronic processing described.

Indications for Use

Indicated for use by dentists, hygienists, and dental assistants for traditional and normal patient treatment procedures in a dental laboratory setting.

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

• Belmont Dental Unit, Model 2000 series (K000799)
• Belmont Dental Unit, Model 6000 series (K000799)

Submission Summary (Full Text)

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### SUMMARY

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| | Dice Detail: | DEC 29 2007 |
|--|----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| | Device Class: | CFR 872.6640 Identified device, Dental<br>Operative Unit and Accessories as<br>Class 1, Reserve. |
| | Trade or proprietary name: | BELMONT QUOLIS 5000 SERIES<br>DENTAL UNIT |
| | Common or usual name: | Dentist's Unit |
| | Classification Name: | Dental Operative Unit and Accessories |
| | Device Listing No.: | 048314 |
| | Classification: | CFR 872.6640 Identified device, Dental<br>Operative Unit and Accessories, as<br>Class 1, Reserve. |
| | Performance Standards: | IEC 60601-1, ISO-7494-2:2003,<br>ISO-7494-1:2004, ISO 60601-1 |
| | Labeling: | Copies are attached. |
| | Fablishment Detail: | |
| | Establishment Registration Number: 96114485 | |
| | TAKARA BELMONT USA, INC.<br>BELMONT Equipment Division<br>101 Belmont Drive<br>Somerset, New Jersey 08873-1204 | |

SUBMITTED BY SCHIFF & COMPANY, WEST CALDWELL, NJ

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# performance compliance:

|EC 60601-1, ISO-7494-2:2003, ISO-7494-1-2004, ISO 60601-1

### Substantially Equivalent:

This Dental Unit and accessories , based on being "Substantially Equivalent" to the Belmont Dental Unit , Model 2000 series and Model 6000 series, as indicated in the Belmont 510k, Pre-market notification submission dated March 7, 2000, K000799. Comparison of QUOLIS 5000 dental unit and Belmont 2000 Series Dental Unit as presented in attachment 2 indicates that both units are substantially equivalent.

Installation, Operating Instruction, Care and Maintenance are attached.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a stylized eagle with three heads, representing the department's commitment to health, human services, and science. The eagle is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement.

DEC 2 0 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Takara Belmont USA, Incorporated C/O Robert Schiff, Ph.D., RAC, CQA President Schiff & Company, Incorporated 1129 Bloomfield Avenue West Caldwell, New Jersey 07006

Re: K072273

Trade/Device Name: Belmont, Dental Unit & Accessories, Quolis 5000 Series Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: NRD Dated: December 14, 2007 Received: December 17, 2007

Dear Dr. Schiff:

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 - Dr. Schiff

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,

Susan Runoe

Chin Lin, Ph.D.

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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#### (K) PREMARKET NOTIFICATION FOR QUOLIS 5000 SERIES DENTAL UNIT TAKARA BELMONT USA, INC.

## Indications for Use

510(k) Number (if known):

owice Name: BELMONT, DENTAL UNIT & ACCESSORIES, QUOLIS 5000 ERIES

dications For Use:

ntal Unit and Accessories are intended for the Dentists, Hygienists, and Dental sistants for traditional and normal patient treatment procedures in the dental atory.

iption Use CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

SE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Ruang

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

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510(k) Number: K1572273