BELMONT UNIT, MODEL 6000 SERIES AND 7500 SERIES

K983661 · Belmont Equipment Corp. · EIA · Jan 12, 1999 · Dental

Device Facts

• Record ID: K983661
• Device Name: BELMONT UNIT, MODEL 6000 SERIES AND 7500 SERIES
• Applicant: Belmont Equipment Corp.
• Product Code: EIA · Dental
• Decision Date: Jan 12, 1999
• 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, AND DENTAL ASSISTANTS FOR TRADITIONAL AND NORMAL PATIENT PROCEDURES IN THE DENTAL OPERATORY. THE DESIGN FUNCTION, AND POSITIONING OF THE UNIT AND ACCESSORIES ARE SIMILAR TO MOST ALL OTHER DENTAL UNITS MANUFACTURED FOR THIS SPECIFIC PURPOSE OVER THE PAST TWENTY YEARS.

Device Story

Belmont Model 6000 and 7500 Series are dental units and accessories used in dental operatories. Operated by dentists and dental assistants, these units provide the necessary infrastructure, positioning, and functional support for standard dental procedures. The device functions as a platform for dental instrumentation and patient positioning, mirroring the design and utility of dental units manufactured over the preceding twenty years. It facilitates clinical workflows by providing a stable, adjustable environment for performing routine dental care.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Dental unit and accessories; design and positioning consistent with standard dental units used for traditional dental procedures.

Indications for Use

Indicated for use by dentists and dental assistants for traditional and normal patient procedures in the dental operatory.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 2 1999

Mr. John E. Collins Senior Vice President Belmont® Equipment Corporation 101 Belmont Drive Somerset, New Jersey 08873-1204

K983661 Re : Belmont Unit, Model 6000 Series and 7500 Trade Name: Series Regulatory Class: I Product Code: EIA October 14, 1998 Dated: October 19, 1998 Received:

Dear Mr. Collins:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug . Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Collins

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Diredtor Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

BELMONT, DENTAL UNIT & ACCESSORIES, MODEL 6000 & 7500 SERIES Device Name:

Indications For Use:

DENTAL UNIT AND ACCESSORIES ARE INTENDED FOR THE DENTISTS, AND DENTAL ASSISTANTS FOR TRADITIONAL AND NORMAL PATIENT PROCEDURES IN THE DENTAL OPERATORY. THE DESIGN FUNCTION, AND POSITIONING OF THE UNIT AND ACCESSORIES ARE SIMILAR TO MOST ALL OTHER DENTAL UNITS MANUFACTURED FOR THIS SPECIFIC PURPOSE OVER THE PAST TWENTY YEARS.

JOHN E. COLLINS
SENIOR VICE PRESIDENT

Sepyember 24, 1998
DATE

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runner

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number .

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use