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• Permanent obturation of the root canal following vital pulp-extirpation.
• Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings.

i-MTA SP Injectable Root Canal Bioceramic Sealer is suitable for use in the single cone and placement of intracanal dressings.

i-MTA SP Injectable Root Canal Bioceramic Sealer is a convenient premixed ready-to-use, injectable white hydraulic bioceramic paste developed for permanent root canal filling and sealing applications. an injectable mineral trioxide aggregate. i-MTA SP is used for root canal sealing and permanent obturation. It is an insoluble and radiopaque material based on a calcium silicates composition, which requires the presence of water to set and harden. i-MTA SP is packaged in an oral irrigator and is supplied with disposable Intra Canal Tips. i-MTA SP may be delivered into the canal via the disposable tips or it can be delivered via traditional methods.

The provided text describes a 510(k) submission for a medical device, the "Injectable Root Canal Bioceramic Sealer (i-MTA SP)". This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than proving the device meets specific acceptance criteria through a clinical study with AI or human readers.

Therefore, the requested information regarding acceptance criteria, AI/human reader performance, sample sizes for test/training sets, expert ground truth establishment, or MRMC studies is not available in the provided text.

The text primarily details:

• Device Name: Injectable Root Canal Bioceramic Sealer (i-MTA SP)
• Regulation Number: 21 CFR 872.3820
• Regulation Name: Root Canal Filling Resin
• Product Code: KIF
• Indications for Use:
  • Permanent obturation of the root canal following vital pulp-extirpation.
  • Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings.
  • Suitable for use in the single cone and placement of intracanal dressings.
• Comparison to Predicate Devices: The document explicitly states its purpose is to show "substantial equivalence" based on "similar physical and biocompatible properties and demonstrates comparable performance specifications to the predicate devices."
• Performance Data Provided:
  • ISO 6876:2012 Dentistry - Root canal sealing materials.
  • Endodontic usage Test- ISO 7405:2018 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
  • Biocompatibility Assessment per FDA Biocompatibility Guidance Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.

No information about AI performance, human reader studies, or the specific criteria for such studies is present in this 510(k) summary. This device is a material used for root canal filling, not a diagnostic or AI-powered device.

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