CLEAN SOURCE I, MODEL CS1000

K981144 · Aquarius Technologies, Inc. · EIA · Sep 15, 1998 · Dental

Device Facts

• Record ID: K981144
• Device Name: CLEAN SOURCE I, MODEL CS1000
• Applicant: Aquarius Technologies, Inc.
• Product Code: EIA · Dental
• Decision Date: Sep 15, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1

Intended Use

The Clean Source One, or CS1, is indicated to be used as an in-line water treatment system to reduce microorganisms in dental unit water lines.

Device Story

Clean Source I (Model CS1000) is an in-line water treatment system designed for dental unit water lines. It functions to reduce microbial contamination within the water delivery system of dental units. The device is installed directly into the water line, acting as a treatment component to improve water quality. It is intended for use in dental clinical settings to assist in maintaining water line hygiene and reducing patient exposure to microorganisms. The device operates as a passive or active treatment system (as specified by the in-line configuration) to mitigate biofilm and microbial proliferation, thereby supporting infection control protocols in dental practices.

Clinical Evidence

No clinical data provided; device clearance based on 510(k) substantial equivalence determination.

Technological Characteristics

In-line water treatment system for dental unit water lines. Mechanical/chemical treatment principle for microbial reduction.

Indications for Use

Indicated for use as an in-line water treatment system to reduce microorganisms in dental unit water lines.

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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 5 1998

Mr. William F. Jeffers Aquarius Technologies, Incorporated 1822 Sunset Place Longmont, Colorado 80501

Re : K981144 Trade Name: Clean Source I, Model CS1000 Regulatory Class: 1 Product Code: EIA June 24, 1998 Dated: Received: June 24, 1998

Dear Mr. Jeffers:

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 Regulations, Title 21, Parts 800 to 895. A 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 regulation regulations In addition, FDA may publish further announcements action. 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. Jeffers

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" (21CFR 807.97) . Other general - C 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,

L. Cilchrist

Timothy R. Ulinski

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

Enclosure

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## Statement of Indications for Use 2.

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The Clean Source One, or CS1, is indicated to be used as an in-line water treatment system to reduce microorganisms in dental unit water lines.

Suza Rroge

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

510(k) Number K631144

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