DENTAPURE DENTAL UNIT WATER LINE FILTER-IODINATED

K963548 · Mrlb Intl., Inc. · EIA · Jan 22, 1997 · Dental

Device Facts

• Record ID: K963548
• Device Name: DENTAPURE DENTAL UNIT WATER LINE FILTER-IODINATED
• Applicant: Mrlb Intl., Inc.
• Product Code: EIA · Dental
• Decision Date: Jan 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1

Intended Use

The DentaPure™ Cartridge is an in-line filter assembly incorporating iodinated resin and a .22 micron filter. The filter is connected within 5" of the connection to the handpiece. The filter portion is of a sufficiently small porosity to be bacterially retentive, and would thereby reduce the amount of bacteria that would reach the patient from the dental water system. The iodine that is released reduces 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. The filter is installed in each dynamic instrument water tubing with quick connect fittings for ease of changing on a weekly basis.

Device Story

DentaPure™ is an in-line, disposable water filter for dental operatory units. It utilizes a .22 micron membrane filter and an iodinated ion exchange resin chamber. As water flows through, the resin releases 2-4 ppm of iodine, acting as a germicide to reduce cross-contamination. The filter is installed via quick-connect fittings within 5 inches of the dental handpiece. It is intended for weekly replacement. By combining mechanical filtration and chemical disinfection, the device reduces bacterial counts in dental water lines to <1 cfu/ml, protecting patients from potential pathogens in the dental water system. It is operated by dental staff as part of routine instrument maintenance.

Clinical Evidence

Bench testing and in-office performance data provided. Laboratory testing showed iodine residual of 0.5 ppm and bacterial counts <1 cfu/ml, with no recontamination observed after 43 days. In-office testing demonstrated a reduction in bacterial colony-forming units from 10^7 cfu/100ml to <10 cfu/100ml using a 0.45 micron filter configuration with iodinated resin.

Technological Characteristics

In-line, disposable filter assembly. Components: 0.22 micron membrane filter, 10.0cm² surface area, 2.5cc iodinated ion exchange resin. Dimensions: 1.5cm diameter, 4.5cm length. Pressure rating: 70 PSI. Vented design to prevent air-lock. Materials: USP Class VI compliant. Installation: Luer-loc quick connect fittings.

Indications for Use

Indicated for use in dental operatory units to reduce bacteria levels in water lines to less than 1 cfu/ml, exceeding ADA recommendations of less than 200 cfu/ml. Used in conjunction with standard sterilization and flushing practices for dental instruments.

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

• Clearline™ Cartridge (K930144)

Submission Summary (Full Text)

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JAN 22 1997
K963S48
MRLB International
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"510 (K) SUMMARY"
[As required by 807.92(c)]

Submitter: MRLB INTERNATIONAL, INC.
305 DeMers Avenue
East Grand Forks, Minnesota 56721

Telephone: [phone]
Fax: [phone]

Contact Person: Rex Hammarback, President

Date: August 27, 1996

Trade Name: DentaPure™ Cartridge

Common Name: Inline Water Filter

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

Equivalent Device: Clearline™ Cartridge, (K930144)
Manufactured by:
SciTech Dental
562 First Avenue South, Suite 700
Seattle, Washington 98104
[per 807.92(a) (3)]

Device Description and Intended Use: The DentaPure™ Cartridge is an in-line filter assembly incorporating iodinated resin and a .22 micron filter. The filter is connected within 5" of the connection to the handpiece. This is illustrated in Figure 1.

A schematic of the cartridge is shown in Figure 2. It consists of a membrane type in-line filter with the outer chamber filled with an iodinated ion exchange resin that imparts 2-4 ppm of iodine

MRLB International, Inc., P.O. Box 4, East Grand Forks, MN 56721, Phone [phone] / Fax [phone]

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into the water as it flows through. The resin is registered with EPA. The filter portion is of a sufficiently small porosity to be bacterially retentive, and would thereby reduce the amount of bacteria that would reach the patient from the dental water system. The iodine that is released reduces 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. The filter is installed in each dynamic instrument water tubing with quick connect fittings for ease of changing on a weekly basis.

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™ Cartridges commonly reduce bacteria levels to less than 1 cfu/ml. Current recommendations of the ADA recommend having less than 200 cfu/ml in dental unit water lines, so this device exceeds those recommendations.

## Performance Data:

Two tests have been conducted to show the efficacy of the DentaPure™ Cartridge and its substantial equivalence to the Clearline™ filter. Tests of the effectiveness of the iodine residual in cross contamination were conducted. Results showed an iodine residual in the tubing of .5 ppm in the first 5 ml, and less than 1 cfu/ml. Samples of the first 5 ml taken the next day showed little or no recontamination after 43 days.

The second set of tests to show equivalence and effectiveness were performed in a dental office, under actual conditions. Tests showed that inclusion of a 0.45 micron filter in conjunction with iodinated resin reduced the number of colony forming units from $10^{7}$ cfu/100ml to less than 10cfu/100ml.

## Comparative Technological Characteristics:

| Parameter | DentaPure™ | Clearline™ |
| --- | --- | --- |
| Filter Type | In-line
Disposable | In-line
Disposable |

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| Parameter | DentaPure™ | Clearline™ |
| --- | --- | --- |
| Installation Fittings | Luer-loc | Luer-loc |
| Components | Membrane Filter
0.22 micron
Column Type
10.0cm² Area
2.5cc Iodinated Ion Exchange Resin | Membrane Filter
0.22 micron
Disc Type
4.2cm² Area
Chlorhexidine overnight soak |
| Maintenance | Weekly Change | Daily Change, connecting tubing between dynamic instrument and filter requires an overnight soak in Chlorhexidine. |
| Air-Lock Potential | Vented | Non-vented |
| Pressure Rating | 70 PSI | 75 PSI |
| Dimensions | 1.5cm Diameter
4.5cm Length | 2.8cm Diameter
2.3cm Length |
| Biosafe | USP Class VI | USP Class VI |

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