MAX-I-PROBE ENDODONTIC SEALER DELIVERY SYSTEM

K971622 · Mpl Technologies, Inc. · KIF · Jun 20, 1997 · Dental

Device Facts

• Record ID: K971622
• Device Name: MAX-I-PROBE ENDODONTIC SEALER DELIVERY SYSTEM
• Applicant: Mpl Technologies, Inc.
• Product Code: KIF · Dental
• Decision Date: Jun 20, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3820
• Device Class: Class 2

Intended Use

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).

Device Story

Device is a delivery system for Zinc Oxide-Eugenol endodontic sealing cement; consists of a type 304 stainless steel tube insert molded into a nylon cartridge. Used by dental professionals in clinical settings. Operation involves loading cartridge into a syringe, inserting tube into prepared root canal, and expressing cement by squeezing a pressure activation handle while withdrawing the probe. Cement coats canal walls prior to gutta percha placement. Device is single-use and disposable; radiation sterilized. Benefits include improved method for applying sealing cement to canal surfaces.

Clinical Evidence

No clinical data. Substantial equivalence is based on design, material, and functional similarity to legally marketed predicate devices.

Technological Characteristics

Materials: Type 304 stainless steel tube, nylon cartridge, polypropylene packaging. Sterilization: Radiation sterilized to AMI guidelines. Form factor: Cartridge-based syringe delivery system.

Indications for Use

Indicated for use by dental professionals in endodontic therapy to apply Zinc Oxide-Eugenol sealing cement to the internal surface of prepared root canals prior to placement of gutta percha or other restorative materials.

Regulatory Classification

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.

Predicate Devices

• Roth International Ltd. Root Canal Cement, Type 801 Elite Grade/Eugenol USP

Submission Summary (Full Text)

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KA71622

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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 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.

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.

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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

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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 [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 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 [phone] or at [phone].

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

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510(k) Number (if known): 长97 | し22

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

Indications For Use:

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).

(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) |