Search Results

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:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document does not specify the exact sample sizes used for each bench test. It states that the tests were conducted "according to protocols based on ISO 6876:2012 and tested for radio-opacity according to a protocol based on ISO 13116:2014". The data provenance is implied to be from the manufacturer's testing, but no specific country of origin for the data or whether it was retrospective or prospective is mentioned. The manufacturer, Prevest Denpro Limited, is located in India.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This type of information is not applicable to this study. The tests performed are benchtop physical and chemical property evaluations rather than evaluations requiring expert human interpretation of medical images or patient outcomes. The "ground truth" for these tests is defined by the objective measurement protocols and acceptance criteria of the specified ISO standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. The study involves objective bench testing, not subjective assessments requiring adjudication by multiple experts.

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 study focuses on the physical and chemical properties of root canal sealers and does not involve AI or human readers for diagnostic interpretation.

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

Not applicable. This study does not involve an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The ground truth for this study is defined by the objective measurement standards and acceptance criteria set forth by international ISO standards (ISO 6876:2012 for most physical properties and ISO 13116:2014 for radio-opacity). For biocompatibility, the ground truth is established by the assessment according to ISO 10993.

8. The sample size for the training set:

Not applicable. This study involves bench testing of medical devices, not training of machine learning models.

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

Not applicable. There is no training set for this type of device submission.

Ask a specific question about this device