MTA ADVANCED MATERIAL

K073218 · Dentsply Interntional · KIF · Jan 7, 2008 · Dental

Device Facts

• Record ID: K073218
• Device Name: MTA ADVANCED MATERIAL
• Applicant: Dentsply Interntional
• Product Code: KIF · Dental
• Decision Date: Jan 7, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MTA ADVANCED MATERIAL is indicated for use in dental procedures that contact the pulp, dentin, or periradicular tissues: - Repairing the periradicular tissues in procedures such as root-end filling, repair of internal or external root resorption, iatrogenic perforation repair, apexification, pulpectomy, or - For protecting injured pulps, pulp-capping, pulpotomies, or cavity liner

Device Story

MTA Advanced Material is a powder and liquid root canal treatment system. Mixing powder and liquid creates a colloidal gel that solidifies into an impermeable barrier; this barrier seals pathways between the root canal system and external tooth surfaces. Used by dental professionals in clinical settings for endodontic and restorative procedures. The device benefits patients by protecting injured pulps and repairing periradicular tissues, preventing communication between the root canal and external surfaces.

Clinical Evidence

No clinical data provided. Safety and effectiveness supported by biocompatibility testing (cytotoxicity, mutagenicity, and sensitization) and performance data.

Technological Characteristics

Powder and liquid root canal treatment system; forms a colloidal gel that solidifies into an impermeable barrier. Components consist of materials previously used in legally marketed dental devices. Biocompatibility confirmed via cytotoxicity, mutagenicity, and sensitization testing.

Indications for Use

Indicated for dental procedures involving pulp, dentin, or periradicular tissues, including root-end filling, root resorption repair, iatrogenic perforation repair, apexification, pulpectomy, pulp-capping, pulpotomies, and cavity lining.

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

• White MTA Material (K011009)

Submission Summary (Full Text)

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K07 3218

## 510(k) SUMMARY

## JAN - 7 2008

DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, PA 17405-0872

| CONTACT: | Helen Lewis |
|----------------------------|--------------------------|
| DATE PREPARED: | NOV 08 2007 |
| TRADE OR PROPRIETARY NAME: | MTA ADVANCED MATERIAL |
| CLASSIFICATION NAME: | Root canal filling resin |
| | 872.3820 |
| PREDICATE DEVICES: | White MTA Material |
| | K011009 |

DEVICE DESCRIPTION: MTA ADVANCED MATERIAL a powder and liquid root canal treatment system. The combination of the powder and liquid creates a colloidal gel that solidifies to form a strong impermeable barrier to seal off pathways of communication between the root canal system and external surfaces of the tooth.

INTENDED USE: MTA ADVANCED MATERIAL is indicated for use in dental procedures that contact the pulp, dentin, or periradicular tissues:

- . Repairing the periradicular tissues in procedures such as root-end filling, repair of internal or external root resorption, iatrogenic perforation repair, apexification, pulpectomy, or
- . For protecting injured pulps, pulp-capping, pulpotomies, or cavity liner

TECHNOLOGICAL CHARACTERISTICS: All of the components found in MTA ADVANCED MATERIAL have been used in legally marketed devices and/or were found safe for dental use. MTA ADVANCED MATERIAL has been evaluated and passed biocompatibility testing for cytotoxicity, mutagenicity, and sensitization.

We believe that the prior use of the components of MTA ADVANCED MATERIAL in legally marketed devices, the performance data provided, and the biocompatibility data provided support the safety and effectiveness of MTA ADVANCED MATERIAL for the indicated uses.

000010

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Helen Lewis Director of Corporate Compliance and Regulatory Affairs DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17405-0872

Re: K073218 Trade/Device Name: MTA Advanced Material Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: II Product Code: KIF Dated: November 8, 2007 Received: November 20, 2007

Dear Ms. Lewis:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2- Ms. Lewis

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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). please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Suite of. Michine Omd

Chiu Lin, Ph.D. Director Division of Anesthesiology. General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE STATEMENT

1<073218

510(k) Number (if known):

MTA ADVANCED MATERIAL Device Name:

Indications for Use:

MTA ADVANCED MATERIAL is indicated for use in dental procedures that contact the pulp, dentin, or periradicular tissues:

- Repairing the periradicular tissues in procedures such as root-end filling, repair of internal . or external root resorption, iatrogenic perforation repair, apexification, pulpectomy, or
- . For protecting injured pulps, pulp-capping, pulpotomies, or cavity liner

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Suvor Roarer

NATIONAL GENERAL LIFE

DENTSPLY International