(115 days)
Not Found
Not Found
No
The device description focuses on the material properties and physical setting process of Mineral Trioxide Aggregate (MTA), a cement-like substance. There is no mention of software, algorithms, data processing, or any terms related to AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device, Mineral Trioxide Aggregate (MTA), is indicated for the repair of pulpal exposures, which is a medical treatment.
No
Explanation: The device, Mineral Trioxide Aggregate (MTA), is described as a cement-like substance used for "repair of pulpal exposures" and sealing pathways. Its function is to solidify and provide a physical seal, which are therapeutic actions, not diagnostic.
No
The device description clearly describes a physical substance (Mineral Trioxide Aggregate) which is a cement-like material used for dental procedures. It is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "repair of pulpal exposures," which is a direct treatment applied to the patient's tooth. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment decisions.
- Device Description: The description details a material that is placed in the tooth and sets to form a hard structure. This is a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information.
Therefore, this device falls under the category of a therapeutic dental device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Indicated clinical applications include use as repair of pulpal exposures.
Product codes
76EMA
Device Description
Mineral Trioxide Aggregate (MTA) is a cement-like substance which seals off all pathways of communication between the root canal system and the external surface of the tooth. The powder consists of fine hydrophilic particles which set in the presence of moisture. Hydration of the powder results in a colloidal gel which solidifies to a hard structure. Mineral Trioxide Aggregate is biocompatible, and exhibits significantly better adaptation to dentinal walls than other materials. It possesses a high degree of sealability; the presence or absence of blood does not affect its sealing ability. Setting time after hydration and application is approximately three hours. In tests, its compressive strength at 21 days is about 70 Mpa. Use of MTA requires only the appropriate hydration of the powder to a viscous consistency. The mixture can then be placed over the exposure site and gently patted into place using a moistened cotton ball if necessary.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Tooth / pulpal exposures
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Shaping The Future of Endodontics
J. Safe Medical Devices Act of 1990 Summary of Safety and Effectiveness:
FEB 1 0 1997
Tulsa Dental Products Submitted by: Russ Vanderslice 5001 East 68th Street, Suite 500 Tulsa, OK 74136
A. Classification Names and Numbers: Dental Cement (other than zinc oxide-eugenol), 76EMA, CFR 872.3275.
B. Common/Usual Names: Dental Cement
C. Proprietary Name: Mineral Trioxide Aggregate (MTA)
D. Establishment Registration Number: 1643003
E. Classification: This device can be classified as a Class II device: D Coment (other than zinc oxide-eugenol), 76 EMA, CFR
F. Performance Standard: Performance standards have not been established.
G. Description of the Device: Mineral Trioxide Aggregate (MTA) is a cement-like substance which seals off all pathways of communication between the root canal system and the external surface of the tooth. Indicated clinical applications include use as repair of pulpal exposures. The powder consists of fine hydrophilic particles which set in the presence of moisture. Hydration of the powder results in a colloidal gel which solidifies to a hard structure.
Mineral Trioxide Aggregate is biocompatible, and exhibits significantly better adaptation to dentinal walls than other materials. It possesses a high degree of sealability; the presence or absence of blood does not affect its sealing ability. Setting time after hydration and application is approximately three hours. In tests, its compressive strength at 21 days is about 70 Mpa. Use of MTA requires only the appropriate hydration of the powder to a viscous consistency. The mixture can then be placed over the exposure site and gently patted into place using a moistened cotton ball if necessary.
H. Determination of Substantial Equivalence Process: This product has the same intended use as similar products currently cleared for marketing by the 510(k) process for the purpose of repairing pulpal exposures. The technological characteristics for this product are substantially equivalent as those of similar products, used for identical purposes, currently on the market. We believe that sufficiently precise specifications for this material from which this product is constructed have been supplied.
Corporate Headquarters 5001 East 68th Street, Suite 500 Tulsa, OK 74136-3332 1-800-379-3432 (918) 493-6598 Fax: (918) 493-6599
Manufacturing 3111 Hanover Road Johnson City, TN 37604 1-800-669-0822 (423) 282-1453 Fax: (423) 282-1995
Distribution 3213 Hanover Road Johnson City, TN 37604 1-800-474-0298 (423) 282-8114 Fax: (423) 282-8661
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