MAX-I-PROBE ENDODONTIC SEALER DELIVERY SYSTEM by MPL TECHNOLOGIES, INC.

This device is intended to be used in endodontic therapy as an improved method for applying Zinc Oxide-Eugenol sealing cement directly to the inside surface of a prepared root canal to coat and seal the canal walls prior to the introduction of gutta percha (or other restorative and filling materials).

Device Description

The MPL Technologies Inc. Max-i-Probe Endodontic Sealer Delivery System is intended to be used in endodonic therapy by dental care professional in a clinical setting to apply Zinc Oxide-Eugenol sealing cement to the inside sufface of a prepared root canal prior to the introduction of gutta percha (or other restorative and filling materials).

The Max-i-Probe Endodontic Sealer Delivery System consists of Zinc Oxide/Eugenol dental cement packaged in a delivery cartridge consisting of a type 304 stainless steel tube insert molded into a nylon cartridge. A sealer cartridge is loaded into a carridge-type syringe. The tube is inserted into the prepared canal. The cernent is expressed directly into the canal by squeezing the pressure activation handle while slowly withdrawing the probe from the canal. The cement is allowed to set. The empty cartridge is removed and discarded.

AI/ML Overview

The provided 510(k) summary for the "Max-i-Probe Endodontic Sealer Delivery System" does not include a study proving device acceptance criteria in the manner typically found in more recent submissions involving performance testing with quantitative metrics. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device.

Here's an analysis of the submission given the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a substantial equivalence determination based on predicate devices, specific numerical acceptance criteria and performance metrics from a dedicated study are not provided in the document. The acceptance is implied by the equivalence to the predicate.

Acceptance Criterion	Reported Device Performance
Material Equivalence	The manufacturing materials and processes are the same or equivalent as the predicate device (Roth International Ltd. Root Canal Cement, Type 801 Elite Grade/Eugenol USP).
Functional Equivalence	The functionality of the Max-i-Probe Endodontic Sealer Delivery System is the same or equivalent as the predicate device.
Intended Use Equivalence	Intended to be used in endodontic therapy by dental care professionals in a clinical setting to apply Zinc Oxide-Eugenol sealing cement to the inside surface of a prepared root canal prior to the introduction of gutta percha (or other restorative and filling materials), which is consistent with the predicate.
Sterility Assurance	Packaged in a sealed polypropylene cartridge pak and radiation sterilized to AMI guidelines. Sterility assurance level at least 10⁻⁶. Each lot is dosimetrically released.

2. Sample Size Used for the Test Set and Data Provenance:

No specific test set or data provenance (e.g., country of origin, retrospective/prospective) is mentioned, as the submission relies on the established safety and effectiveness of the predicate device and the equivalence of the new device to it.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. The ground truth, in this context, refers to the established safety and effectiveness of the predicate device, not data from a new study with expert review.

4. Adjudication Method for the Test Set:

Not applicable. No new test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

No MRMC study was conducted or referenced in this 510(k) summary. The submission focuses on device equivalence, not comparative effectiveness with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. The device is a physical delivery system for endodontic sealer, not an algorithm or AI system.

7. The Type of Ground Truth Used:

The "ground truth" for this submission is the established safety and effectiveness of the legally marketed predicate device (Roth International Ltd. Root Canal Cement, Type 801 Elite Grade/Eugenol USP). The new device's materials, manufacturing processes, and function are asserted to be equivalent to this predicate.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device, so there is no training set in the conventional sense.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. There is no training set mentioned.

Summary

{0}------------------------------------------------

KA71622

Image /page/0/Picture/4 description: The image shows the logo for MPL Technologies, which is a company. The logo consists of a geometric shape on the left, followed by the text "MPL Technologies" in bold, black letters. Below the company name, it says "A SoloPak Company" in a smaller font. The geometric shape is a stylized, abstract design with a series of lines and angles.

JUN 20 1997

510(k) SUMMARY

June 13, 1997

To Whom it may concern:

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Devices Act of 1990 and CFR 807.92:

Trade Name - Max-i-Probe Endodontic Sealer Delivery System Common Name - Endodontic Sealing Cement Classification Name - Root Canal Filling resin (21CFR & 872.3820)

The manufacturing materials and processes, and functionality of the Max-i-Probe Endodontic Sealer Delivery System are the same or equivalent as the predicate devices named in the submission: Roth International Ltd. Root Canal Cement, Type 801 Elite Grade/Eugenol USP.

Each Max-i-Probe Endodontic Sealer Delivery System cartridge is packaged in a sealed polypropylene cartridge pak and radiation sterilized to AMI guidelines. The sterility assurance level is at least 10 . Each lot is dosimetrically released.

Based on the fact that the Max-i-Probe Endodontic Sealer Delivery System utilizes similar and equivalent designs, components, manufecturing processes as currently legally marketed products, this product is safe and effective when used as intended.

Sincerely,

Daniel O'Toole Jr.

Daniel J. Østerby Quality Assurance Director MPL Technologies, Inc.

MPI. Technologies Inc.

{1}------------------------------------------------

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with three curved lines above them, resembling a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 20 1997

Mr. Daniel J. Osterby 'Ouality Assurance Director MPL Technologies, Incorporated 9400 King Street Franklin Park, Illinois 60131

Re : K971622 Trade Name: Max-I-Probe Endodontic Sealer Delivery System Regulatory Class: II Product Code: KIF Dated: April 10, 1997 Received: May 2, 1997

Dear Mr. Osterby:

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, Druq, 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 aqainst 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 Requlations, Title 21, Parts 800 to 895. ಗಿ 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 requlation may result in requlatory 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

{2}------------------------------------------------

Page 2 - Mr. Osterby

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 genera 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

{3}------------------------------------------------

3 - 1

| |

510(k) Number (if known): 长97 | し22

Device Name: Max-i-Probe Endodontic Sealer Delivery System

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runner

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
510(k) Number	K971622

Prescription Use (Per 21 CFR 801.109)	OR	Over-The-Counter Use
		(Optional Format 1-2-96)

Regulation Number and Section

§ 872.3820 Root canal filling resin.

(a)
Identification. A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.(b)
Classification. (1) Class II if chloroform is not used as an ingredient in the device.(2) Class III if chloroform is used as an ingredient in the device.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other root canal filling resin shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.