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K Number
K073218
Device Name
MTA ADVANCED MATERIAL
Manufacturer
DENTSPLY INTERNTIONAL
Date Cleared
2008-01-07

(53 days)

Product Code
KIF
Regulation Number
872.3820
Type
Traditional
Panel
DE
Reference & Predicate Devices
K011009
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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
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:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance for a test set.
  3. Number or qualifications of experts for ground truth.
  4. Adjudication methods.
  5. MRMC comparative effectiveness studies.
  6. Standalone algorithm performance.
  7. Type of ground truth used.
  8. Sample size for a training set.
  9. 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.

§ 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.