K Number
K102163
Device Name
REALSEAL XT SEALER
Manufacturer
Date Cleared
2010-10-16

(75 days)

Product Code
Regulation Number
872.3820
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
RealSeal XT Sealer is indicated for permanent root canal obturation and sealing, in combination with root canal points or an obturator.
Device Description
RealSeal XT Sealer is intended for permanent obturation of root canals of teeth in combination with root canal points. The subject device is a self-etch methacrylate/epoxy resin root canal sealant in a catalyst/base paste formulation, which combines the methacrylate and epoxies resin chemistry. Due to its self-etching and adhering properties, RealSeal XT Sealer does not require the use of an etchant, primer or adhesive to achieve its intended function. It has also been designed for dual cure capabilities. That is, it not only self-cures after mixing the catalyst and base parts in a specific time period, but it can also be light cured by the doctor if there is a need to see an immediate hardening of the material, which facilitates the immediate cleaning of the material after a root canal filling procedure. RedSeal XT Sealer will be packaged in a 4 ml dual-barrel syringe for both the catalyst and base parts. The material can be mixed using an auto-mixing tip attached to the syringe or the material can be mixed by hand on a paper pad, if desirable.
More Information

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No
The device description focuses on the chemical composition and physical properties of a root canal sealant, with no mention of AI or ML technologies.

Yes
The device is a root canal sealant used for permanent obturation and sealing of root canals, which is a therapeutic intervention to treat and preserve teeth.

No

The device is a permanent root canal obturation and sealing material, not a tool for diagnosing medical conditions.

No

The device description clearly indicates it is a physical material (sealant) in a syringe, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for "permanent root canal obturation and sealing." This is a therapeutic procedure performed directly on the patient's tooth, not a test performed on a sample taken from the body to diagnose a condition.
  • Device Description: The description details a material used to fill and seal the root canal, a physical intervention. It doesn't describe a test or analysis of a biological sample.
  • Lack of IVD Characteristics: The description doesn't mention any of the typical characteristics of an IVD, such as:
    • Analyzing a biological sample (blood, urine, tissue, etc.)
    • Providing information for diagnosis, monitoring, or screening
    • Using reagents or assays to detect specific substances

The device is a medical device used in a dental procedure, but it falls under the category of a therapeutic or restorative device, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

RealSeal XT Sealer is indicated for permanent root canal obturation and sealing, in combination with root canal points or an obturator.

Product codes (comma separated list FDA assigned to the subject device)

KIF

Device Description

RealSeal XT Sealer is intended for permanent obturation of root canals of teeth in combination with root canal points. The subject device is a self-etch methacrylate/epoxy resin root canal sealant in a catalyst/base paste formulation, which combines the methacrylate and epoxies resin chemistry. Due to its self-etching and adhering properties, RealSeal XT Sealer does not require the use of an etchant, primer or adhesive to achieve its intended function. It has also been designed for dual cure capabilities. That is, it not only self-cures after mixing the catalyst and base parts in a specific time period, but it can also be light cured by the doctor if there is a need to see an immediate hardening of the material, which facilitates the immediate cleaning of the material after a root canal filling procedure. RedSeal XT Sealer will be packaged in a 4 ml dual-barrel syringe for both the catalyst and base parts. The material can be mixed using an auto-mixing tip attached to the syringe or the material can be mixed by hand on a paper pad, if desirable.

Mentions image processing

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Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

Root canals of teeth

Indicated Patient Age Range

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Intended User / Care Setting

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Description of the training set, sample size, data source, and annotation protocol

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Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Biocompatibility studies have been completed, which demonstrates that RealSeal XT Sealer is safe for its intended use.
This 510(k) submission also includes data from bench testing used to evaluate the performance characteristics of RealSeal XT Sealer compared to the predicate devices. The characteristics evaluated include working time, water solubility and bond strength.
Based upon the biocompatibility tests and bench testing, the clinical performance of RealSeal XT Sealer is substantially equivalent to the predicate devices.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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§ 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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