DENTAPURE DP40 CARTRIDGE

K992868 · Mrlb Intl., Inc. · EIA · Sep 7, 1999 · Dental

Device Facts

• Record ID: K992868
• Device Name: DENTAPURE DP40 CARTRIDGE
• Applicant: Mrlb Intl., Inc.
• Product Code: EIA · Dental
• Decision Date: Sep 7, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.6640
• Device Class: Class 1

Intended Use

The DentaPure® DP40 Cartridge is for use on dental unit water lines attached to the dynamic dental instruments, i.e., high-speed handpiece, three-way air/water syringe and ultrasonic scaler. This cartridge in conjunction with currently recommended practices regarding sterilization and flushing of dental instruments reduces bacteria from the water supplied through the instruments to a level that will meet or exceed the current ADA recommendations for water quality having a maximum of 200 cfu/ml.

Device Story

DentaPure DP40 is an in-line dental unit waterline purification cartridge. Device connects to pickup tube of bottle water systems via quick-connect fittings. Internal components include iodinated ion exchange resin and polyolefin filter. As water flows through, resin releases 2-6 ppm iodine to reduce biofilm and cross-contamination. Filter retains waterborne particulates. Used in dental clinics; installed by dental staff. Output is treated water delivered through dental instruments. Benefits include reduced bacterial contamination in dental water lines, helping meet ADA water quality standards.

Clinical Evidence

Bench testing only. Device performance demonstrated by ability to reduce bacteria levels to less than 100 cfu/ml, exceeding ADA recommendations of less than 200 cfu/ml.

Technological Characteristics

In-line cartridge assembly; polyolefin filter; iodinated ion exchange resin (EPA registered). Dimensions/form factor: retrofittable to modern dental units with independent bottle water systems. Connectivity: none. Energy source: none (passive flow). Sterilization: disposable unit.

Indications for Use

Indicated for use in dental unit water lines supplying dynamic dental instruments (high-speed handpiece, three-way air/water syringe, ultrasonic scaler) to reduce waterborne bacteria levels to below 200 cfu/ml.

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.

Predicate Devices

• DentaPure DP1 (K963548)

Submission Summary (Full Text)

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K992868

SEP 7 1999

## "510 (K) SUMMARY" [As required by 807.92(c)]

Submitter:

MRLB INTERNATIONAL, INC. 2450 College Way Fergus Falls, Minnesota 56537

[phone] Telephone: Fax: [phone] Contact Person: B. J. Hammarback

August 8,1999 Date:

DentaPure® DP40 Cartridge Trade Name:

Common Name: Dental Unit Waterline Purification Cartridge

Classification Name: Accessory for "Unit, Dental Operative" per CFR 872.6640) Class I.

DentaPure® DP1 (K963548) Equivalent Device: Manufactured by: MRLB International, Inc. 2450 College Way Fergus Falls, MN 56537 [per 807.92(a) (3)]

Device Description and Intended Use:

The DentaPure® DP40 Cartridge is an in-line assembly incorporating iodinated resin and a polyolefin filter. The cartridge is connected to the pickup tube of a bottle water system. This is illustrated in Figure 1.

A schematic of the cartridge is shown in Figure 2. It consists of a polyolefin in-line filter with the inner chamber filled with an iodinated ion exchange resin that imparts 2-6 ppm of iodine into the water as it flows through. The resin is registered with EPA. The

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filter portion is of a sufficiently small porosity to retain water-born particulate, and would thereby reduce the amount of particulate that would reach the patient from the dental water system. The iodine that is released reduces biofilm and the chance of cross contamination by introducing the germicide, iodine, into the water system downstream of the filter.

The DentaPure® Cartridge is a disposable unit, retrofittable to all modern dental operatory units with independent bottle water systems. The cartridge is installed in the bottle reservoir tubing with quick connect fittings for ease of change.

The instructions for use of the DentaPure® Cartridge require that the dental instruments be sterilized in conformity with current recommendations for sterilization and flushing. When used in conjunction with these normal practices, the DentaPure® DP40 Cartridges commonly reduce bacteria levels to less than 100 cfiv/ml. Current recommendations of the ADA recommend having less than 200 cfu/ml in dental unit water lines, so this device exceeds those recommendations.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three heads facing left, representing health, human services, and well-being. 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 7 1999

Mr. B.J. Hammarback MRLB International, Incorporated 2450 College Way Fergus Falls, Minnesota 56537

K992868 Re : Trade Name: DentaPure DP40 Cartridge Requlatory Class: I Product Code: EIA Dated: August 23, 1999 Received: August 26, 1999

Dear Mr. Hammarback:

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 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. ਸ 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

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## Page 2 - Mr. Hammarback

verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA regarability 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.

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 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 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

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

Enclosure

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## Indications for Use Statement

Page Contents

Ver/ 3 - 4/24/96

Applicant: MRLB International, Inc.

510(k) Number (if known):

Device Name: DentaPure DP40 Waterline Purification Cartridge

Indications For Use:

The DentaPure® DP40 Cartridge is for use on dental unit water lines attached to the dynamic dental instruments, i.e., high-speed handpiece, three-way air/water syringe and ultrasonic scaler. This cartridge in conjunction with currently recommended practices regarding sterilization and flushing of dental instruments reduces bacteria from the water supplied through the instruments to a level that will meet or exceed the current ADA recommendations for water quality having a maximum of 200 cfu/ml.

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NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)

. . Capirol, 2 - 8 - 1 - 1 - 1 -

Susan Rumm

Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number .

(Optional Format 1-2-96)

Prescription Use (Per 21 CFR 801.109)

C-1