(90 days)
- 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.
§ 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.