(53 days)
Not Found
No
The device description and intended use describe a material used in dental procedures, not a software or system that would typically incorporate AI/ML. There are no mentions of AI, ML, image processing, or data sets.
Yes
The device is used in dental procedures to repair and protect tissues, and to create an impermeable barrier, which are therapeutic actions aimed at treating or alleviating a condition.
No
Explanation: The device description and intended use indicate that MTA ADVANCED MATERIAL is a root canal treatment system used to repair tissues and create a barrier. It is a therapeutic material, not a device designed to diagnose a condition or disease.
No
The device description clearly states it is a "powder and liquid root canal treatment system," indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a material used in dental procedures to repair and protect tissues within and around the tooth. This is a therapeutic and restorative application, not a diagnostic one.
- Device Description: The description details a material that solidifies to form a barrier. This is a physical function within the body, not a test performed on a sample outside the body to diagnose a condition.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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
Product codes (comma separated list FDA assigned to the subject device)
KIF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pulp, dentin, or periradicular tissues
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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
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