(49 days)
Not Found
Not Found
No
The device description details a mechanical system for delivering cement and does not mention any computational or learning components.
No
The device is used to apply dental cement to a root canal, which is a component of a dental procedure but not in itself a therapeutic treatment.
No
This device is designed for delivering sealing cement within a root canal, not for diagnosing a condition or disease. It is a therapeutic delivery system.
No
The device description explicitly details hardware components including a stainless steel tube, nylon cartridge, and a cartridge-type syringe with a pressure activation handle, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device is used directly within the patient's body (the root canal) to apply a sealing cement. It is a tool for a dental procedure, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly states it's for "applying Zinc Oxide-Eugenol sealing cement directly to the inside surface of a prepared root canal." This is a therapeutic/restorative procedure, not a diagnostic one.
Therefore, this device falls under the category of a medical device used in a clinical setting for a dental procedure, but it is not an IVD.
N/A
Intended Use / Indications for 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).
Product codes
KIF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
inside surface of a prepared root canal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental care professional in a clinical setting
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Roth International Ltd. Root Canal Cement, Type 801 Elite Grade/Eugenol USP.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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 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.
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:
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) |