THE PROMA PERCEPTION, RESPONSE AND COMPASS SYSTEM AND ACCESSORIES

K980106 · Proma, Inc. · EIA · Aug 3, 1998 · Dental

Device Facts

• Record ID: K980106
• Device Name: THE PROMA PERCEPTION, RESPONSE AND COMPASS SYSTEM AND ACCESSORIES
• Applicant: Proma, Inc.
• Product Code: EIA · Dental
• Decision Date: Aug 3, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1

Intended Use

This dental operating unit system is intended for use by professionally trained demists and their supervised dental hygienists and assistants to support their general, nonsurgical dental diagnostic and restorative procedures performed within contemporary standards of dental patient care. When properly used and cared for, the system is safe and effective and meets advertised claims. When equipped with isolated patient water (bottle) system that is properly installed and cared for, it has been shown to reduce the number of microbes in the water dispensed.

Device Story

Dental operating unit system; supports general, nonsurgical dental diagnostic and restorative procedures. Operated by dentists, hygienists, and assistants in clinical settings. Includes optional isolated patient water (bottle) system to reduce dispensed water microbial load. Provides mechanical support and utility for dental instruments/procedures. Benefits patient by facilitating standard dental care and providing cleaner water delivery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental operating unit; includes optional isolated water bottle system for microbial reduction. Class I device (Product Code EIA).

Indications for Use

Indicated for use by dentists, dental hygienists, and assistants to support general, nonsurgical dental diagnostic and restorative procedures in dental patients.

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

3 1098 AUG

Mr. Frank A. Betush Quality Manager Proma, Incorporated 751 East Kingshill Place Carson, California 90746-1223

Re : K980106 The Proma Perception, Response and Compass Trade Name: System and Accessories Regulatory Class: I Product Code: EIA Dated: April 24, 1998 Received: May 5, 1998

Dear Mr. Betush:

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 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, Druq, 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. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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## Page 2 - Mr. Betush

This letter will allow you to begin marketing your device as The FDA described in your 510(k) premarket notification. 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 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" (21 CFR 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/dsmamain.html".

Sincerely yours,

S. Autman for

Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Form revised at FDA request-2nd revision 24 Apr 98

Indications for use Form Page (1 of 1)

| 510 (K) number (if known): | K# 980106 |
|----------------------------|-----------------------|
| Device name: | Dental Operating Unit |
| Indications for use: | |

This dental operating unit system is intended for use by professionally trained demists and their supervised dental hygienists and assistants to support their general, nonsurgical dental diagnostic and restorative procedures performed within contemporary standards of dental patient care. When properly used and cared for, the system is safe and effective and meets advertised claims. When equipped with isolated patient water (bottle) system that is properly installed and cared for, it has been shown to reduce the number of microbes in the water dispensed.

(Please do not write below this line-continue on another page)

(concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Susan Runge

(Division Sisin-Off) (Division Sign-Off)
Division Sign-Off, Infection Control, . . . . Devices and Genera 169010 510(k) Number -

OR Over-The-Counter Use

(Optional Format 1-2-96)