MTA MATERIAL is indicated for the repair of root canals as an apical plug during Apexification, and repair of Root Perforations during root canal therapy (endodontic therapy) or as a consequence of internal resorption.

Device Description

MTA MATERIAL is identical to K964174, Mineral Trioxide Aggregate (found substantially equivalent February 10, 1997). This submission is for a new intended use. MTA MATERIAL is a powder consisting of fine hydrophilic particles. Hydration of the powder results in a colloidal gel, which solidifies to a hard structure.

AI/ML Overview

This 510(k) submission (K980332) for "MTA MATERIAL" describes a device that is identical in composition to a previously cleared device (K964174, Mineral Trioxide Aggregate) but is seeking clearance for new intended uses. Therefore, the acceptance criteria and performance data presented relate to the suitability of the existing material for these new indications.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission for a new intended use of an identical material, the acceptance criteria are implicitly tied to demonstrating the effectiveness of the material for the specified new indications through various in-vitro and animal studies. There aren't explicit quantifiable "acceptance criteria" presented in the manner of a typical performance study for a novel device, but rather a demonstration of biological and functional performance in relevant models.

Acceptance Criterion (Implicit)	Reported Device Performance
For Non-Apical Root Perforation Repair:
Ability to effectively seal non-apical (lateral) root perforations, demonstrating less leakage than existing materials.	Study: In-vitro extracted tooth model (dye penetration study) comparing MTA MATERIAL to IRM® filling material and amalgam. Performance: MTA MATERIAL showed the least degree of dye leakage. Significantly less leakage (p<0.05) than IRM and amalgam. Even with overfilled or underfilled perforations, MTA MATERIAL had the least dye penetration (p<0.05).
For Furcal Perforation Repair:
Ability to promote healing and minimize inflammation in furcal perforations, performing comparably or better than existing materials.	Study: In-vivo study with seven dogs, comparing MTA MATERIAL to amalgam. Evaluation included immediate and delayed repair with bacterial contamination. Performance (Immediate Repair): Only 1 of 6 teeth repaired immediately with MTA MATERIAL exhibited inflammation, while all amalgam-filled perforations had often moderate to severe inflammation. 5 of 6 MTA-filled teeth had cemental repair over the material. Performance (Delayed Repair): Inflammation in 4 of 7 MTA-filled teeth, while all amalgam-filled teeth had frequently severe and more extensive inflammation.
For Apical Plug During Apexification (Ability to serve as an apical barrier):
Ability to induce hard tissue formation and minimize lesion size at the apex in immature roots, performing comparably or better than existing materials.	Study (Exhibit 3): In-vivo study with seven dogs to evaluate apical barrier function in induced periapical lesions. Performance: MTA MATERIAL had the smallest lesions histologically and radiographically among experimental materials and functioned well as a one-step apical plug material in an open apex. Study (Exhibit 4): In-vivo study with dogs comparing MTA MATERIAL to osteogenic protein-1 (OP-1) and calcium hydroxide for hard tissue barrier formation in immature roots. Performance: MTA MATERIAL induced apical hard tissue formation more often than other test materials (p=0.004). The degree of inflammation was lowest for MTA MATERIAL.
For Biocompatibility/Safety:
Continued demonstration of biocompatibility and safety for the new intended uses.	Performance: MTA MATERIAL is identical to K964174. Prior biocompatibility studies (not detailed in this document) for K964174, along with the animal study performance data provided for the new intended uses, support the safety.

2. Sample Sizes Used for the Test Set and Data Provenance

Non-Apical Root Perforation Repair (Exhibit 1):
- Test Set Sample Size: "an in-vitro extracted tooth model" - specific number of teeth not provided, but comparisons were made between MTA, IRM, and amalgam groups.
- Data Provenance: In-vitro study. Country of origin not specified, but typically conducted in a laboratory setting. No indication of retrospective or prospective for this in-vitro model.
Furcal Perforations (Exhibit 2):
- Test Set Sample Size: Seven dogs. Each dog likely provided multiple teeth, as the study mentions "In half of the teeth..." and "all six teeth" or "four of seven teeth."
- Data Provenance: Prospective in-vivo animal study (dogs). Country of origin not specified.
Apical Plug During Apexification (Exhibit 3):
- Test Set Sample Size: Seven dogs.
- Data Provenance: Prospective in-vivo animal study (dogs). Country of origin not specified.
Apical Plug During Apexification (Exhibit 4):
- Test Set Sample Size: Not explicitly stated, but "dogs" were used.
- Data Provenance: Prospective in-vivo animal study (dogs). Country of origin not specified.

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

For the animal studies, the ground truth was established through histological and radiographic examination. The number and qualifications of the experts performing these evaluations are not specified in the provided text. It is assumed these would be veterinary pathologists or experienced researchers in the field of endodontics, but no explicit details are given.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing ground truth in the studies. Given the nature of animal model evaluations (histology, radiology), it's common for a single expert or a panel to evaluate, but the method isn't detailed here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The studies described are not MRMC studies comparing human readers with and without AI assistance. This submission is for a material (MTA MATERIAL), not an AI device.

6. Standalone (Algorithm Only) Performance Study

No. This submission is for a material, not an algorithm.

7. Type of Ground Truth Used

The ground truth for the performance studies was primarily based on:

In-vitro Measurement: Dye penetration (Exhibit 1).
Histology: Examination of tissue samples for inflammation, cemental repair, and lesion size (Exhibits 2, 3, 4).
Radiography: Assessment of lesion size (Exhibit 3).
Hard Tissue Formation: Quantified visually or histomorphometrically (Exhibit 4).

8. Sample Size for the Training Set

This submission is for a material, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI. The performance data presented relates to experimental validation studies for the material itself.

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

Not applicable, as there is no training set for an AI algorithm. The material's properties and performance are established through scientific studies using the methods described in point 7.

Summary

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K980332

510(k) SUMMARY FEB 24 1998

Image /page/0/Picture/2 description: The image shows the word "DENTSPLY" in all capital letters. The font is bold and sans-serif. The letters are tightly spaced together, and the word is centered in the image.

NAME & ADDRESS:

DENTSPLY International

570 West College Avenue P.O. Box 872 York, PA 17405-0872 (717) 845-7511 Fox (717) 854-2343

P. J. Lehn Telefax (717) 849-4343

CONTACT:	P. Jeffery Lehn
DATE PREPARED:	January 23,1998
TRADE OR PROPRIETARY NAME:	MTA MATERIAL
COMMON OR USUAL NAME:	Root Filling Material
CLASSIFICATION NAME:	Root canal filling resin material	872.3820
PREDICATE DEVICE:	Mineral Trioxide Aggregate	K964174

DEVICE DESCRIPTION: MTA MATERIAL is identical to K964174, Mineral Trioxide Aggregate (found substantially equivalent February 10, 1997). This submission is for a new intended use.

MTA MATERIAL is a powder consisting of fine hydrophilic particles. Hydration of the powder results in a colloidal gel, which solidifies to a hard structure.

INTENDED USE: MTA MATERIAL is indicated for the repair of root canals as an apical plug during Apexification, and repair of Root Perforations during root canal therapy (endodontic therapy) or as a consequence of internal resorption.

TECHNOLOGICAL CHARACTERISTICS: MTA MATERIAL is identical to DENTSPLY'S K964174, Mineral Trioxide Aggregate. This submission is for an additional intended use.

The fact that the formula is identical to K964174 (found substantially equivalent February 10, 1997) leads to the conclusion that biocompatibility studies with the formulation are not necessary

Therefore, we believe that the prior use of the formula in K964174, the animal study performance data provided, and the results of previous testing in K964174 support the safety and effectiveness of MTA MATERIAL for the new intended use.

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Substantial Equivalence Comparison:

ID of Predicate Device:

K964174, Mineral Trioxide Aggregate, is the predicate device for this submission. MTA MATERIAL is identical to the predicate. This submission is for a new intended use only.

Statement of Similarities and/or Differences:

MTA MATERIAL is identical to K964174. This submission is for a new intended use only.

This submission addresses the new intended use: Repair of root canals as an apical plug . during Apexification, and repair of Root Perforations during root canal therapy (endodontic therapy) or as a consequence of internal resorption.
K964174 addresses the use: Intended to be applied to a tooth to protect the pulp.

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Performance Data:

The use of MTA MATERIAL to repair root canals as an apical plug during Apexification, and to repair Root Perforations during root canal therapy (endodontic therapy) or as a consequence of internal resorption is addressed in Exhibits 1 through 4.

Non-Apical Root Perforation Repair (Exhibit 1)

The ability of MTA MATERIAL to seal non-apical (lateral) root perforations was investigated in an in-vitro extracted tooth model, which compared its performance to IRM® filling material and amalgam. In this dye penetration study, the MTA MATERIAL showed the least degree of dye leakage. There was no significant statistical difference between the IRM and amalgam groups, while MTA leaked significantly less than the other two materials (p<0.05). Even when perforations were overfilled or underfilled, MTA MATERIAL still had the least dye penetration associated with it when compared to IRM and amalgam (p<0.05).

Furcal Perforations (Exhibit 2)

The suitability of MTA MATERIAL for the repair of furcal perforations was investigated in a study with seven dogs, which compared its performance to that of amalgam. In half of the teeth, the perforation was filled immediately with either amalgam or MTA MATERIAL. In the other half the perforations were left open to salivary contamination for six weeks to allow for bacterial contamination and the formation of inflammatory lesions in the furcation, after which time the perforations were cleaned and filled with either amalgam or MTA MATERIAL. Histological examination after four months showed only one of six teeth repaired immediately with MTA MATERIAL exhibited inflammation, while all perforations filled with amalgam had inflammation associated with them, that was often moderate to severe. In addition five of the six teeth filled with MTA MATERIAL had some cemental repair over the material. Those perforations that were allowed to remain open and then repaired, exhibited inflammation in four of seven teeth filled with MTA MATERIAL. Those filled with amalgam were all associated with inflammation that was frequently severe and more extensive.

Apical Plug During Apexification (Exhibit 3)

The ability of MTA MATERIAL to serve as an apical barner was evaluated in a study with seven dogs. Following preparation of the root canals, periadicular lesions were induced by allowing the canals to remain open for 14 days and then sealing them with zinc oxide-eugenol cement for 14 days. All infected canals were then cleaned, shaped and irrigated with sodium hypochlorite. Calcium hydroxide was placed in the canals as a disinfectant for one week and then removed. MTA was placed in the canals and condensed. Evaluations were made after nine weeks. The MTA MATERIAL had the smallest lesions histologically and radiographically of all of the experimental materials investigated, and functioned well as a one-step apical plug material in an open apex.

Apical Plug During Apexification (Exhibit 4)

The comparative efficacy of osteogenic protein-1 (OP-1), calcium hydroxide, and MTA MATERIAL to form a hard tissue barner in immature roots was evaluated in dogs. The amount of hard tissue formation and the degree of inflammation were evaluated histomorphometrically. MTA MATERIAL induced apical hard tissue formation more often than the other test materials (p=0.004). The degree of inflammation, in ascending order, was MTA MATERIAL, calcium hydroxide, OP-1, and collagen carrier alone. No significant statistical differences in the degree of inflammation were found. Based on the results, MTA MATERIAL can be used as an apical barrier for apexification in immature roots.

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Safety Data:

MTA MATERIAL is identical to DENTSPLY'S K964174, Mineral Trioxide Aggregate. This submission is for an additional intended use.

The fact that the formula is identical to K964174 (found substantially equivalent February 10, 1997) results in the decision that biocompatibility studies with the final formulation are not necessary.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 4 1998

Mr. P. Jeffrey Lehn Mirector, Corporate Compliance and Regulatory Affairs DENTSPLY International 570 West College Avenue P.O. Box 872 York, Pennsylvania 17405-0872

K980332 Re : MTA Material Trade Name: Requlatory Class: II Product Code: KIF Dated: January 23, 1998 Received: January 28, 1998

، ، Dear Mr. Lehn:

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 Requiations - Title 21, Parts-800 to 895. - A - -- -substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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

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Page 2 - Mr. Lehn

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Patricia Cuciniello

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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PREMARKET NOTIFICATION

INDICATIONS FOR USE STATEMENT

510(K) Number:

Image /page/6/Picture/3 description: The image shows a handwritten string of alphanumeric characters. The string is 'K980332'. The characters are written in a cursive style with thick, dark lines, and there is a horizontal line underlining the entire string.

Device Name:

MTA MATERIAL

MTA MATERIAL is indicated for the repair of root canals as an apical plug

during Apexification, and repair of Root Perforations during root canal

therapy (endodontic therapy) or as a consequence of internal resorption.

Suan RUME
(Division Sign-offurrence of GDBH Office of Device Evaluation (ODE)

H, Office of Device Evaluation (ODE) Division of Dent and General Ho 510(k) Numbe OR Prescription Use Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.109)

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.