← Product Code [EIA](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIA) · K964942

# INFECTION CONTROL CARTRIDGE (K964942)

_Dentalpure Corp. · EIA · Jun 19, 1997 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIA/K964942

## Device Facts

- **Applicant:** Dentalpure Corp.
- **Product Code:** [EIA](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIA.md)
- **Decision Date:** Jun 19, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.6640
- **Device Class:** Class 1
- **Review Panel:** Dental

## Indications for Use

FOR USE TO REDUCE BACTERIA AND VIRUSES PRESENT IN DENTAL UNIT WATER LINE WATER. THE DEVICE CAN BE USED ON THE GENERAL PATIENT POPULATION, WITH THE EXCEPTION OF PATIENTS WHO ARE PREGNANT OR WHO ARE SENSITIVE TO IODINE.

## Device Story

Dental unit water treatment cartridge; installed in dental unit water lines; functions to reduce microbial contamination (bacteria and viruses) in water used during dental procedures; intended for use in dental clinics; operated by dental staff; provides treated water to dental instruments; benefits patient by reducing exposure to waterborne pathogens during treatment.

## Clinical Evidence

No clinical data provided; bench testing only.

## Technological Characteristics

Water treatment cartridge; utilizes chemical reduction/treatment principle; intended for integration into dental unit water supply lines.

## Regulatory 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. Stephen J. Poindexter
President
Dentalpure Corporation
300 South Owasson Boulevard
St. Paul, Minnesota 55117

JUN 19 1997

Re: K964942
Trade Name: Dental Unit Water Treatment Cartridge
Regulatory Class: I
Product Code: EIA
Dated: May 16, 1997
Received: May 20, 1997

Dear Mr. Poindexter:

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 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 regulations.

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Page 2 - Mr. Poindexter

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 (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or at (301) 443-6597.

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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06/16/97 MON 15:24 FAX 301 480 3002
FAA/ODE/DDIGD
002
Page 1 of 1

510(k) Number (if known): K964942

Device Name: DENTAL UNIT WATER TREATMENT CARTRIDGE

Indications For Use:
REDUCE 6-16-97/AP
FOR USE TO BACTERIA AND
VIRUSES PRESENT IN DENTAL
UNIT WATER LINE WATER. THE
DEVICE CAN BE USED ON THE
GENERAL PATIENT POPULATION,
WITH THE EXCEPTION OF PATIENTS
WHO ARE PREGNANT OR WHO ARE
SENSITIVE TO IODINE.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number: K964942

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐

(Optional Format 1-2-96)

2/2 d ReE169 oNTime Jun. 16. 2:15PM
Wd0g:2 L66191unf

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIA/K964942](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIA/K964942)

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