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CalApex is a calcium hydroxide, polymeric resin, root canal filling material that is used in conjunction with gutta percha or silver endodontic points.

Calplus is a temporary or permanent root canal filling material for use following pulpectomy, or for apexogenesis or apexification.

Cerafill RCS is a MTA (mineral trioxide aggregate) based root canal sealer that provides complete and permanent sealing of root canals. It can be used with or without root canal obturation materials.

Endoseal is used for permanent obturation of the root canal space with the aid of obturating points in accordance with ISO 6876 for Dental Root Canal Sealing materials.

Nanoseal S is indicated in patients for permanent obturations of root canal after vital extirpation or after treatment of pulpal gangrene and temporary filling.

Zical Ultra Paste is used for permanent obturation of the root canal space with the aid of obturating points.

Zical Ultra Powder/Liquid is used for permanent obturation of the root canal space with the aid of obturating points.

CalApex is a non-eugenol, radiopaque, calcium hydroxide polymeric resin root canal filling material. It is a two part, base/catalyst – paste/paste system that is mixed in equal portions. The mixture is then carried to the root canal with endodontic obturation points or directly dispensed in the root canal depending on delivery method, e.g. tube or dual-barrel syringe.

Calplus can be used as a temporary or permanent root canal filling material.

Cerafill RCS is an endodontic sealer based on MTA, providing a biocompatible and effective root canal filling. It is premixed and pre-loaded in a syringe, which allows a complete filling of the entire root canal including accessory and lateral canals. The product is eugenol-free and will not impede adhesion inside the root canal.

Endoseal is a Zinc Oxide/Eugenol root canal sealant. The product is made up of two separate components, a powder base and a liquid catalyst, to form the final device.

Nanoseal S is a permanent root canal filling material which is silicone based (polydimethylsiloxane). It is cold flowable and is in a dual barrel cartridge.

Zical Ultra Paste is a two-part, base/accelerator, paste/paste system that is mixed in equal portions. The mixture is carried to the root canal with endodontic obturation points. The product comes in a dual barrel cartridge.

Zical Ultra Powder/Liquid is a two-part, powder/liquid system for permanent filling of root canals. The mixture is carried to the root canal with endodontic obturation points.

The document describes the acceptance criteria and performance of several root canal sealers developed by Prevest Denpro Limited. The study involved a series of bench tests conducted according to ISO standards to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

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Apacal ART and is suitable for several indications including:

• · Liner to be applied to the interior of a prepared cavity prior to the insertion of restorative materials.
• · Indirect pulp capping or management of deep caries lesions, or
• · Direct pulp capping

CAL-LC is indicated for use as a cavity liner and pulp capping material. It is self-adhering and highly filled.

Calcigel is a calcium hydroxide paste that has a creamy consistency and is suitable for several indications including;

• · Indirect pulp capping or management of deep caries lesions, or
  · Direct pulp capping

CalUltra is a hard-setting calcium hydroxide cavity liner and pulp capping agent to be used in conjunction with all permanent restorative techniques.

Apacal ART is a light cured single-component paste reinforced with tricalcium phosphate and hydroxyapatite. It is sold in a syringe with accompanying applicator tips.

CAL-LC is a highly filled cavity liner and pulp capping material. It is sold in a syringe with accompanying applicator tips.

Calcigel is a creamy, ready -to -use calcium hydroxide paste with a pH above 11. It is syringe with accompanying applicator tips.

CalUltra is a hard-setting calcium hydroxide cavity liner and pulp capping agent. CalUltra is a two-part base/catalyst paste/paste system. It is sold in a tubes with accompanying spatula and mixing pad.

The provided text describes the substantial equivalence of Prevest Denpro Cavity Liners to predicate devices, focusing on physical parameters and material composition rather than AI performance. Therefore, many of the requested categories related to AI studies and expert review are not applicable to this document.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All tests results met the criteria in standards." The acceptance criteria are implicit in the ISO and USP standards referenced for each test. The performance is reported as meeting these standards.

2. Sample size used for the test set and the data provenance

The document does not specify the sample sizes used for the testing of these physical and chemical properties. The data provenance is presumed to be from the manufacturer's testing conducted in India (Prevest Denpro Limited, Jammu, India). The testing is described as being performed "according to protocols based on" relevant ISO and USP standards, indicating manufacturer-conducted in vitro/bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a medical device clearance based on material properties and performance against established international standards, not an AI or diagnostic device requiring expert ground truth for image interpretation or similar tasks.

4. Adjudication method for the test set

Not applicable. This type of adjudication is typically used in clinical or image-based studies. The "adjudication" here is the assessment against specified ISO/USP standard requirements.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The device is a dental material, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The device is a dental material, not an algorithm.

7. The type of ground truth used

The "ground truth" for the device's performance is based on the objective measurements against established international and national standards (ISO and USP) for material properties (e.g., flexural strength, depth of cure, water sorption/solubility, pH, setting time, radio-opacity).

8. The sample size for the training set

Not applicable. There is no training set mentioned, as this is not an AI or machine learning device.

9. How the ground truth for the training set was established

Not applicable, as there is no training set.

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GuttaSil is a material for permanent obturation of root canals after treatment of pulpal gangrene and temporary filling of the canal.

GuttaSil, a product in the form of a paste which combines gutta-percha with a sealer. The gutta-percha powder is mixed in a matrix of polyvinylsiloxane. It is convenient since sealing and obturation are simultaneously possible without heating and the root canal can be filled in a quick manner. This device contains a syringe, auto-mix& Endo tips, spatula, and mixing pads.

This document describes the acceptance criteria and study proving the device meets those criteria for the GuttaSil, a root canal filling material.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for each specific test within the non-clinical testing. It only generally refers to "the following testing was conducted." The provenance of the data is not specified (e.g., country of origin, retrospective or prospective), but it is implied to be laboratory testing conducted by or for Meta Biomed Co., Ltd.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. The tests conducted are non-clinical, primarily physical, chemical, and biocompatibility tests based on ISO standards. These types of tests typically do not involve human expert adjudication of results in the way clinical performance studies do.

4. Adjudication Method for the Test Set

This information is not applicable as the tests are non-clinical performance and biocompatibility tests against quantitative ISO standards, not evaluations requiring human rater adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes non-clinical performance and biocompatibility testing. The device is a material for root canal filling, not an AI-assisted diagnostic or treatment planning tool.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

Not Applicable. This device is a material (gutta-percha with a sealer) used in a medical procedure, not an algorithm or software. Therefore, the concept of "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used

For the non-clinical performance tests, the "ground truth" is defined by the specifications and acceptable ranges outlined in the ISO 6876:2012 standard for root canal sealing materials.

For the biocompatibility tests, the "ground truth" is adherence to the biocompatibility criteria specified in the relevant ISO 10993 series standards.

8. The Sample Size for the Training Set

Not Applicable. This device is a physical material, not an AI algorithm or model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not Applicable, as there is no training set for this type of device.

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TRC-Pex: The TRC-Pex is a temporary root canal sealer for use in the treatment of root canals, following a pulpectomy or for apexegenesis or apexification.
Radic-Sealer: The Radic-Sealer is a root canal sealing of root canals following established endodontic procedures and may be used in conjunction with the auxiliary materials in the root canal (i.e. gutta percha points). The Radic-Sealer is intended for use by qualified healthcare personnel trained in its use.

TRC-Pex: TRC-Pex is an immediately available pre-mixed root canal filling material based on Calcium Hydroxide and lodoform. This pre-mixed temporary filling material maintains a constant flow, which makes it easy to inject into the canal. Depending on apicoectomy or root canal therapies, it can be used as a temporary root canal filling material. The device is contained in a plastic syringe and the system includes a plunger, disposable tips, a rubber, a protective cap, an indo stop and a holder for direction control of the tip.
Radic-Sealer: Radic-Sealer is a root canal sealing & filling material based on epoxy-amine resin. Radic-Sealer is contained in a dual syringe which makes it easy to mix and inject. It makes permanent obturation of root canals using adhesion properties between root canal walls and the root canal filling materials. The base and catalyst are contained separately in the chambers of two separate plastic syringes. The product consists of a mixing tip with a mixing joint, a protective cap, a mixing pad, and a plunger.

Here's an analysis of the provided text regarding the acceptance criteria and study for the TRC-Pex and Radic-Sealer devices:

This document is a 510(k) summary for medical devices, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a new device's safety and effectiveness from scratch through extensive clinical trials. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed within the context of showing equivalence to existing, legally marketed devices.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the standards and properties of the predicate devices. The study aims to show that the new devices meet the established performance parameters defined by these standards.

Study Proving Acceptance Criteria:

The study conducted was a series of non-clinical performance tests and biocompatibility tests. The document states:

• "Performance testing that confirmed to the protocols and recommended values described in ISO 6876 was performed."
• "Biocompatibility data were provided to demonstrate substantial equivalence to the predicate devices."
• "Side-by-Side cytotoxicity testing was performed that compared the TRC-Pex and a predicate device, and the test results showed that they have similar biocompatibility properties."
• "The bench and biocompatibility tests provided evidence that the chemical and physical properties of TRC-Pex and Radic-Sealer are substantially equivalent to the predicate devices."

Additional Information Not Present in the Document:

The provided text describes a 510(k) submission for dental materials (root canal filling and sealing materials). For this type of device, the performance evaluation primarily relies on bench testing and biocompatibility studies as per ISO standards, which is what the document reports. It does not involve studies typically associated with AI/software devices or diagnostic image analysis. Therefore, many of the requested points below are not applicable or cannot be answered from the provided text.

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not explicitly stated for each test, but standard protocols for material testing (e.g., ISO 6876, ISO 10993 series) involve a specified number of samples for each property being evaluated (e.g., usually 3-5 samples per test condition for material science, but this is not detailed here).
• Data Provenance: The tests were conducted by KM Corporation, likely in a laboratory setting. No country of origin for "data" in the sense of patient data is applicable. These are material properties tests.
• Retrospective or Prospective: Not applicable. These are laboratory-based material characterization tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. For material properties and biocompatibility, "ground truth" is established by adherence to standardized testing methods (e.g., ISO standards) and instrument measurements, not expert consensus in the human interpretation sense.

4. Adjudication method for the test set:

• Not applicable. Material property tests are objective measurements, not subject to human adjudication or interpretation disputes.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This is not an AI/imaging device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Not applicable. This is not an AI/software device.

7. The type of ground truth used:

• Bench Test Ground Truth: Measured physical and chemical properties according to ISO standards.
• Biocompatibility Ground Truth: Cellular responses (e.g., cytotoxicity) and tissue reactions according to ISO 10993 standards and comparison to established predicate device performance.

8. The sample size for the training set:

• Not applicable. These materials are not "trained" in the machine learning sense. The "training" might refer to the development and refinement process of the material formulations, which is not detailed here.

9. How the ground truth for the training set was established:

• Not applicable for this type of device submission.

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