The DentaPure® DP90 and DP365 Cartridge is for use on dental unit water lines attached to the Second handpiece, three-way air/water syringe and dynamic demail mstruments, f.e., mgr. opod has with currently recommended practices regarding ultrasonic Scaler. This outhego in setyantator stermization and Instilling of contax morent ADA recommendations for water quality having a maximum of 200 cfu/ml.

Device Description

The DentaPure® DP90 and DP365 Cartridges are in-line assemblies incorporating iodinated resin and a polypropylene filter. The cartridge is connected to the municipal water supply at the air/water service junction box in each operatory. It consists of a polypropylene 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 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.

AI/ML Overview

The provided text describes a medical device, the DentaPure® DP90 and DP365 Cartridge, and its regulatory clearance via a 510(k) submission. However, it does not contain information related to a study proving the device meets specific acceptance criteria. The letter from the FDA confirms substantial equivalence to a predicate device and approval for marketing, but it does not detail performance testing or acceptance criteria.

Therefore, I cannot fulfill the request to provide:

A table of acceptance criteria and reported device performance
Sample size used for the test set and data provenance
Number of experts and qualifications for ground truth establishment
Adjudication method
MRMC comparative effectiveness study details (effect size)
Standalone performance study details
Type of ground truth used
Sample size for the training set
How ground truth for the training set was established

The document focuses on the regulatory aspects (510(k) summary, FDA clearance letter) and general claims about the device's function and adherence to ADA guidelines (reducing bacteria levels to less than 100 cfu/ml, which is below the ADA recommendation of 200 cfu/ml). It mentions a prior equivalent device (DentaPure® DP1, K963548), suggesting that the substantial equivalence was likely based on comparison to the performance of that device, but no specific study details are given in this text.

Summary

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1893

SEP 8 1999

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

Submitter:	MRLB INTERNATIONAL, INC.2450 College WayFergus Falls, Minnesota 56537
Telephone:	(218) 739-2222
Fax:	(218) 736-3241
Contact Person:	B. J. Hammarback
Date:	August 8,1999
Trade Name:	DentaPure® DP90 Cartridge; DentaPure® DP365 Cartridge
Common Name:	Dental Unit Waterline Purification Cartridge
Classification Name:	Accessory for "Unit, Dental Operative" per CFR 872.6640) Class I.
Equivalent Device:	DentaPure® DP1 (K963548)Manufactured by:MRLB International, Inc.2450 College WayFergus Falls, MN 56537[per 807.92(a) (3)]
Device Descriptionand Intended Use:	The DentaPure® DP90 and DP365 Cartridges are in-line assembliesincorporating iodinated resin and a polypropylene filter. The

cartridge is connected to the municipal water supply at the air/water service junction box in each operatory. This is illustrated in Figure 1.

A schematic of the cartridge is shown in Figure 2. It consists of a polypropylene in-line filter with the inner chamber filled with an iodinated ion exchange resin that imparts 2-6 ppm of iodine into the

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water as it_flows through. The resin is registered with EPA. The 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. The cartridge is connected to the municipal water supply at the air/water service junction box in each operatory.

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® DP90 and DP365 Cartridge commonly reduce bacteria levels to less than 100 cfulml. Current recommendations of the ADA recommend having less than 200 cfu/ml in dental unit water lines, so this device complies with those recommendations.

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Image /page/2/Picture/2 description: The image shows a circular logo with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The symbol in the center appears to be a stylized representation of a person or figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 8 1999

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

K992893 Re : DentaPure® DP 90 Cartridge, Dentapure® DP Trade Name: 365 Cartridge Requlatory Class: I Product Code: EIA Dated: Auqust 25, 1999 Received: August 27, 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 requlations 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) requlation (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

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Page 2 -Mr. Hammarback

the Act for devices under the Electronic Product Radiation the Act for devices ander or other Federal laws or regulations.

This letter will allow you to begin marketing your device as fire reed in your 510(k) premarket notification. The FDA described in your alence of your device to a legally rinding of babbandasice results in a classification for your marketta predication of mits 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 regaradiagnostic devices), please contact the Office of Compliance at (301) 594-4690. Additionally, for questions on the promotion and advertising of your device, please contact che office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
the regulation entitled, "Misbranding by reference to information on your responsibilities under the Act may be Information on Jourision of Small Manufacturers Assistance obtained from one (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Tim A. Ulataniski

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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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® DP90 and DP365 Cartridge is for use on dental unit water lines attached to the The Delliar une Dr 70 and Dr 30 Second handpiece, three-way air/water syringe and dynamic demail mstruments, f.e., mgr. opod has with currently recommended practices regarding ultrasonic Scaler. This outhego in setyantator stermization and Instilling of contax morent ADA recommendations for water quality having a maximum of 200 cfu/ml.

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

NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Sinan Russo

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

Prescription Use (Per 21 CFR 801.109)

Regulation Number and Section

§ 872.6640 Dental operative unit and accessories.

(a)
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.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.