← Product Code [EIA](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIA) · K964271

# IGN 500 TM WATER CLEANING UNIT WITH CALBENIUM LIQUID (K964271)

_Airel-West · EIA · Dec 19, 1997 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIA/K964271

## Device Facts

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

## Indications for Use

Intended to help prevent gross contamination of the dental operatory unit.

## Device Story

The IGN 500 Waterline Unit with Calbenium Liquid is a dental accessory designed to maintain cleanliness within dental operatory waterlines. It functions by introducing Calbenium Liquid into the dental unit's water system to mitigate microbial contamination and prevent the buildup of biofilm or gross contaminants. The device is intended for use in a clinical dental setting and is operated by dental professionals. By reducing waterline contamination, the device supports the maintenance of sanitary conditions during dental procedures, potentially reducing the risk of patient exposure to contaminated water during treatment.

## Clinical Evidence

No clinical data provided; bench testing only.

## Technological Characteristics

The device consists of a waterline cleaning unit and a chemical additive (Calbenium Liquid). It operates as a mechanical/chemical system for water treatment within dental units. No specific materials, software, or electronic sensing components are described.

## 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)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

{0}

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

DEC 19 1997

Airiel-West
C/O Daniel A. Kracov
Patton Boggs, L.L.P.
2550 M Street, N.W.
6th Floor
Washington, DC 20037

Re: K964271
Trade Name: IGN 500 Waterline Unit
Regulatory Class: I
Product Code: EIA
Dated: September 19, 1997
Received: September 22, 1997

Dear Mr. Kracov:

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

{1}

Page 2 - Mr. Kracov

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 (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 (301) 443-6597 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

{2}

PB LLP 6TH FL ct
ID:202-457-6315
DEC 17'97 13:58 No.035 P.04

510(k) Number (if known): K964271

Device Name: IGN 500™ WATER CLEANING UNIT WITH CALBENIUM LIQUID™

Indications For Use:

Intended to help prevent gross contamination of the dental operatory unit.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rupner

(Division Sign-Off)

Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K964271

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐

(Optional Format 1-2-96)

---

**Source:** [https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIA/K964271](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIA/K964271)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com