MTA MATERIAL

K980332 · Dentsply Intl. · KIF · Feb 24, 1998 · Dental

Device Facts

• Record ID: K980332
• Device Name: MTA MATERIAL
• Applicant: Dentsply Intl.
• Product Code: KIF · Dental
• Decision Date: Feb 24, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3820
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

MTA MATERIAL is a powder composed of fine hydrophilic particles; hydration creates a colloidal gel that solidifies into a hard structure. Used by dentists/endodontists in clinical settings for root canal repair. Functions as an apical plug during apexification and as a sealant for root perforations. Applied directly to the site of the perforation or root apex. Provides a physical barrier to seal the canal; promotes hard tissue formation; reduces inflammation compared to traditional materials like amalgam. Benefits include improved sealing of root defects and support for natural cemental repair.

Clinical Evidence

Evidence includes four animal/in-vitro studies. In-vitro dye penetration study (n=not specified) showed MTA had significantly less leakage than IRM or amalgam (p<0.05). Dog study (n=7) on furcal perforations showed MTA had less inflammation and higher cemental repair than amalgam. Dog study (n=7) on apical plugs showed MTA functioned as an effective one-step barrier with smallest lesions. Comparative dog study (n=not specified) on apexification showed MTA induced apical hard tissue formation more frequently than calcium hydroxide or OP-1 (p=0.004).

Technological Characteristics

Powder consisting of fine hydrophilic particles; hydrates to form a colloidal gel that solidifies into a hard structure. Identical formulation to predicate K964174. No specific ASTM standards or software/energy sources mentioned.

Indications for Use

Indicated for patients requiring endodontic therapy for root canal repair as an apical plug during apexification, or repair of root perforations resulting from endodontic therapy or internal resorption.

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

• Mineral Trioxide Aggregate (K964174)

Reference Devices

• IRM filling material
• Amalgam
• Osteogenic protein-1 (OP-1)
• Calcium hydroxide

Submission Summary (Full Text)

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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 [phone] Fox [phone]

P. J. Lehn Telefax [phone]

| 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.

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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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 [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 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 [phone] 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:

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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)