PURE COMPANY FLUID DELIVERY SYSTEM

K971278 · Pure Co. · EIA · Jul 3, 1997 · Dental

Device Facts

• Record ID: K971278
• Device Name: PURE COMPANY FLUID DELIVERY SYSTEM
• Applicant: Pure Co.
• Product Code: EIA · Dental
• Decision Date: Jul 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1

Intended Use

The Pure Fluid Delivery System is a dual reservoir system that isolates a dental operatory from municipal or rural water supplies. It can also be used to introduce bottled solutions that are commonly used in dental procedures through the dental unit. The Pure Fluid Delivery System also has a .01 Micron air filter that permits air purging of the dental unit with higher quality air. The operation of the Fluid Delivery System is facilitated by a rotary switch on the control face that permits switching between the contents of the two bottles being used. There is a built-in pressure relief valve that limits pressure in the bottles to 40psi as a safety feature. The control face panel also has a quick disconnect that allows the solutions in the bottle selected to be used in an external dental device.

Device Story

Dual reservoir system for dental operatories; isolates dental unit from municipal/rural water supplies; enables delivery of bottled solutions. Features rotary switch for reservoir selection; 0.01-micron air filter for air purging; pressure relief valve (40psi limit) for safety; quick disconnect for external device connection. Operated by dental staff in clinical settings. Benefits include water supply isolation and controlled delivery of procedural solutions.

Technological Characteristics

Dual reservoir system; 0.01-micron air filter; rotary switch control; pressure relief valve (40psi limit); quick disconnect interface.

Indications for Use

Indicated for use in dental operatories to isolate dental units from municipal/rural water supplies and to deliver bottled solutions for dental procedures.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. Gray S. Nunnelly
Chief Executive Officer
Pure Company
2045 Preisker Lane
Santa Maria, California 93454

JUL - 3 1997

Re: K971278
Trade Name: Pure Company Fluid Delivery System
Regulatory Class: I
Product Code: EIA
Dated: April 4, 1997
Received: April 7, 1997

Dear Mr. Nunnelly:

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, 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 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

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Page 2 - Mr. Nunnelly

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

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 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,

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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510(k) Number: K971278

Device Name: Pure Fluid Delivery System

Indications For Use:

The Pure Fluid Delivery System is a dual reservoir system that isolates a dental operatory from municipal or rural water supplies. It can also be used to introduce bottled solutions that are commonly used in dental procedures through the dental unit. The Pure Fluid Delivery System also has a .01 Micron air filter that permits air purging of the dental unit with higher quality air.

The operation of the Fluid Delivery System is facilitated by a rotary switch on the control face that permits switching between the contents of the two bottles being used. There is a built-in pressure relief valve that limits pressure in the bottles to 40psi as a safety feature.

The control face panel also has a quick disconnect that allows the solutions in the bottle selected to be used in an external dental device.

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Prescription Use
(Per 21 CFR 801.109)

OR

Over the Counter Use