MTA ADVANCED MATERIAL by DENTSPLY INTERNTIONAL

. 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 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.

AI/ML Overview

I am sorry, but the provided text from the 510(k) summary (K073218) for "MTA ADVANCED MATERIAL" does not contain the acceptance criteria or a study proving the device meets acceptance criteria in the format you've requested.

The document is a 510(k) summary for a dental root canal filling resin. It focuses on demonstrating substantial equivalence to a predicate device based on:

Device Description: What the product is and what it does.
Intended Use: The clinical applications of the device.
Technological Characteristics: Highlighting that its components are legally marketed and safe for dental use.
Biocompatibility Testing: Mentioning that it passed tests for cytotoxicity, mutagenicity, and sensitization.

There is no mention of:

A table of acceptance criteria and reported device performance.
Sample sizes or data provenance for a test set.
Number or qualifications of experts for ground truth.
Adjudication methods.
MRMC comparative effectiveness studies.
Standalone algorithm performance.
Type of ground truth used.
Sample size for a training set.
How ground truth for a training set was established.

This type of information is typically found in performance studies or clinical trials, which are not detailed in this 510(k) summary. The document focuses on the regulatory approval process rather than a detailed performance study report.

Summary

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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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suvor Roarer

NATIONAL GENERAL LIFE

DENTSPLY International

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.