DCI WATER PURIFIER

K971727 · Dental Components, Inc. · EIA · Sep 12, 1997 · Dental

Device Facts

• Record ID: K971727
• Device Name: DCI WATER PURIFIER
• Applicant: Dental Components, Inc.
• Product Code: EIA · Dental
• Decision Date: Sep 12, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1

Intended Use

A device which provides water exposed Ultraviolet for a denta ( conjunction wit operate treatment devices, to veduce Water bacteria in the water number o

Device Story

DCI Water Purifier uses ultraviolet (UV) light to reduce bacterial counts in water supplied to dental treatment devices. Device integrates into dental water lines; operates by exposing water flow to UV radiation. Intended for use in dental clinical settings to improve water quality for patient treatment. Output is treated water with reduced microbial load; assists clinicians in maintaining sanitary conditions during dental procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

UV-based water purification system for dental applications. Class I device (Product Code: EIA).

Indications for Use

Indicated for reduction of bacteria in water used in conjunction with dental treatment devices.

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

SEP | 2 |997

Mr. Richard W. Hanson Official Correspondent Dental Components Incorporated 305 North Springbrook Road Newberq, Oregon 97132

Re: K971727 DCI Water Purifier Trade Name: Regulatory Class: I Product Code: EIA Dated: August 19, 1997 Received: Auqust 22, 1997

Dear Mr. Hanson:

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 The general controls provisions of the Act 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 Requlation (QS) for Medical Devices: General requlation (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 requlation may result in requlatory 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. Hanson

through 542 of the Act for devices under the Electronic enrough 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 assorizon in formalence 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" (21 CFR 807.97). Other gener 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,

Patricia Creciente/for

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

Enclosure

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K971727 510(k) Number (if known):

Device Name: DCI WATER PURIFIER

Indications For Use:

A device which provides water exposed Ultraviolet for a denta ( conjunction wit operate treatment devices, to veduce Water bacteria in the water number o

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Ruanev

n Sion-Off f Dental, Infection Cor

Prescription Use (Per 21 CFR 801.109

OR

Over - The-Counter Use -

(Optional Format 1-2-96)