(27 days)
Not Found
No
The device description and performance studies focus on the material properties and clinical outcomes of a mineral trioxide aggregate, with no mention of AI or ML.
Yes
The device is indicated for the repair of root canals and root perforations, which are therapeutic interventions.
No
This device is described as a material (a powder that solidifies) used for repairing root canals and perforations, not for diagnosing conditions. Its intended use is therapeutic, involving the repair of damage, rather than the identification or analysis of a disease or condition.
No
The device description clearly states that MTA MATERIAL is a powder that solidifies into a hard structure, 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 the device being used within the body for the repair of root canals and perforations. This is a therapeutic or restorative application, not a diagnostic one.
- Device Description: The description focuses on the physical properties of the material and how it solidifies, which is relevant to its function as a repair material.
- Anatomical Site: The anatomical sites mentioned are all within the body (root canals, root perforations, etc.).
- Performance Studies: The performance studies evaluate the material's ability to seal and promote healing within the body (dye leakage, inflammation, hard tissue formation). These are not diagnostic performance metrics.
IVD devices are used outside the body to examine specimens (like blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
KIF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Root canals, Apex, Root Perforations, Furcal perforations
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)
Non-Apical Root Perforation Repair (Exhibit 1)
Study type: in-vitro extracted tooth model, dye penetration study
Sample size: Not specified
Key results: MTA MATERIAL showed the least degree of dye leakage compared to IRM® filling material and amalgam. No significant statistical difference between IRM and amalgam groups, while MTA leaked significantly less than the other two materials (p
§ 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
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 (717) 845-7511 Fox (717) 854-2343
P. J. Lehn Telefax (717) 849-4343
| 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.
1
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.
2
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