(188 days)
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No
The provided text describes a material (MTA) used for dental procedures and does not mention any computational or analytical capabilities, let alone AI/ML.
Yes
The device is used for the repair of root perforations, root-end filings, pulp capping, and repair of root canals, which are all therapeutic dental procedures.
No
The document describes the intended uses of the MTA devices for repairing root perforations, root-end fillings, pulp capping, and apical plugs during apexification. These are all therapeutic and reparative procedures, not diagnostic ones.
No
The provided text describes materials (MTA-B, MTA-T, MTA-XR, MTA-XR Flow) used in dental procedures, which are physical substances, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed (repair of root perforations, root-end fillings, pulp capping, apical plug during apexification) are all procedures performed directly on the patient's body within the root canal system.
- Lack of IVD Characteristics: IVDs are devices used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. The provided description does not mention any such use or the analysis of biological samples.
- Anatomical Site: The anatomical site is listed as "root canals," which is an internal part of the body.
Therefore, this device appears to be a material used in dental procedures performed in vivo (within the living body), not an IVD.
N/A
Intended Use / Indications for Use
MTA-B :
- Repair of root perforations during root canal therapy
- Root-end filings
- Pulp capping
- Repair of root canals as an apical plug during apexification
MTA-T :
- Repair of root perforations during root canal therapy
- Root-end filings
- Pulp capping
- Repair of root canals as an apical plug during apexification
MTA-XR:
- Repair of root perforations during root canal therapy
- Root-end filings
- Pulp capping
- Repair of root canals as an apical plug during apexification
MTA-XR Flow:
- Repair of root perforations during root canal therapy
- Pulp capping
- Repair of root canals as an apical plug during apexification
Product codes (comma separated list FDA assigned to the subject device)
KIF
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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
Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 24, 2013
S&C Polymer Silicon-Und Composite Spezialitaeten GmbH Dr. Christian Boettcher Regulatory Compliance Officer Robert-Bosch-Strasse 2 Elmshorn Schleswig-Holstein GERMANY 25335
Re: K130125
Trade/Device Name: MTA Cements Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: II Product Code: KIF Dated: June 19, 2013 Received: June 26, 2013
Dear Dr. Boettcher:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
1
Page 2 - Dr. Boettcher
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I hat FDA has made a determination that your device complies with other requirements of the Act that 1 Dr. has Intactions and regulations administered by other Federal agencies. You must or any I edelar banales and store registements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (2) CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Image /page/1/Picture/8 description: The image shows the text "Mary S. Runner - S" in a bold, sans-serif font. The words "Mary" and "Runner" are in solid black, while the "S." is filled with a pattern of small squares and lines. The "- S" at the end is also in solid black and slightly smaller than the other words.
Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Statement of Indication for Use
| 510(k) Number (if known): | K130125 |
|---|---|
| Device Name: | MTA Cements |
| Indications for Use: | |
| MTA-B : | Repair of root perforations during root canal therapyRoot-end filingsPulp cappingRepair of root canals as an apical plug during apexification |
| MTA-T : | Repair of root perforations during root canal therapyRoot-end filingsPulp cappingRepair of root canals as an apical plug during apexification |
| MTA-XR: | Repair of root perforations during root canal therapyRoot-end filingsPulp cappingRepair of root canals as an apical plug during apexification |
| MTA-XR Flow: | Repair of root perforations during root canal therapyPulp cappingRepair of root canals as an apical plug during apexification |
| Prescription Use: | |
| (Part 21 CFR 801 Subpart D) | and / or Over-The-Counter Use: (Part 21 CFR 807 Subpart C) |
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Sheena A. Green-S | |
|---|---|
| 2013.07.24 09:51:31:-04'00' | |
| for M. Susan Runner, DDS, MA |
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K130125 |
|---|---|
| ---------------- | --------- |