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The C&B Ceramic material is used for fabrications such as inlays, onlays, onlays, veneers and full crown restorations.

The C&B Permanent material is used for fabrications such as inlays, onlays, onlays, veneers and full crown restorations

C&B Interim material is indicated for the fabrication of temporary dental restorations in conjunction with extra-oral lightcuring equipment.

Prevest C&B, Ceramic Resin is a light-curing material with ceramic fillers used for the 3D printing/ fabrication of Ceramic Crown & Bridge dental prosthesis for use in DLP, LCD/MSLA 3D printers. It is reactive to wavelength of light between 385nm and 405nm. Recommended printers and light curing unit are Asiga Max UV, Ackuretta SOL and Acuretta Curie. It is stored in 500 and 1000ml HDPE bottles and is available in several shades: A1 /A2 /A3 /A3.5 /B1 /B2 /B3 /C2 /D3 /Bleach/Extra Bleach based on the shade guide.

Prevest C&B, Interim resin is a light-curing material with glass fillers used for the 3D printing/ fabrication of long term temporary Crown & Bridge dental prosthesis for use in DLP, LCD/MSLA 3D printers. It is reactive to wavelength of light between 385nm and 405nm. Recommended printers and light curing unit are Asiga Max UV, Ackuretta SOL and Acuretta Curie. It is stored in 500 and 1000ml HDPE bottles and is available in several Shades: A1 /A2 /A3 /A3.5 /B1 /B2 /B3/ C2 /D3/Bleach/Extra Bleach based on the shade guide.

Prevest C&B, Permanent resin is a light-curing material with glass fillers for the 3D printing/fabrication of Permanent crown and bride dental prosthesis for use in DLP, LCD/MSLA 3D printers. It is reactive to wavelength of light between 385nm and 405nm. Recommended printers and light curing unit are Asiga Max UV, Ackuretta SOL and Acuretta Curie. It is stored in 500 and 1000ml HDPE bottles and is available in several Shades: A1 / A2 / A3 / A3.5 / B1 / B2 / B3 / C2 / D3/Bleach/Extra Bleach based on the shade guide.

These materials are used for the additive manufacturing of crown and bridge prosthesis following the workflow as depicted below:

The provided text describes a 510(k) premarket notification for three dental resin materials: C&B Ceramic, C&B Permanent, and C&B Interim. The document states that these devices are substantially equivalent to predicate devices based on various testing results.

Here's the breakdown of the acceptance criteria and the study information as requested:

1. Table of Acceptance Criteria and Reported Device Performance:

The document directly compares the subject devices (C&B Ceramic, C&B Permanent, C&B Interim) with predicate/reference devices against established ISO standards for certain physical parameters.

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Fusion Core DC Flo is indicated for use as core build up material on vital teeth, sealing root canal openings, cavity floor liner, post cementation, restorative material, and as a dentin replacement material.

Fusion Flo is indicated for direct filling of class V (cervical caries, root erosions, and wedge shaped defects), anterior restorations( Class III and IV), small posterior restorations, repair of composite/ceramic veneers, and blocking out of undercuts.

Fusion Flo SE is indicated for direct filling of class V (cervical caries, root erosion, wedge shaped defects), anterior restorations (Class III and IV), small posterior restorations,

Fusion I-Seal is indicated for Class I and Class II restorations, as a liner under composite restorations, and as a pit and fissure sealant.

Magma NT is indicated for direct restoration in anterior and posterior teeth classes I, III, IV and V, and porcelain/ composite repairs.

Fusion Core DC Flo is dual-curing, radiopaque, flowable restoration for core build-up composite supplied in an auto-mix delivery system.

Fusion Flo is a flowable composite of medium viscosity used for fillings in anterior teeth and small fillings in posterior teeth. Fusion Flo can be used separately or with Magma-NT composites.

Fusion Flo SE is a self-etch, self-adhesive flowable composite. The flowable composite is ready for use and doesn't require the preparatory steps of etching, priming and bonding. Fusion Flo SE can be used separately or with Magma-NT composites.

Fusion I-Seal is a single component, light cured flowable composite.

Magma-NT is a visible light cured, radio opaque highly filled hybrid composite restorative material for anterior and posterior restoration of all teeth.

The provided text describes the acceptance criteria and performance of several dental composite resins from Prevest Denpro Limited (Fusion Core DC Flo, Fusion Flo SE, Fusion I-Seal, and Magna NT) as part of a 510(k) premarket notification to the FDA. The study aims to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally based on meeting the requirements of ISO 4049:2019 and ISO 13116:2014, with specific values mentioned for some parameters. The reported device performance indicates that "All test results met the criteria in standards."

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Fusion Bond 5 is indicated for direct composite or compomer restorations, adhesive cementation, and composite repair.

Fusion Bond 7 is indicated for bonding of composites to tooth structure, core build up, and adhesive cementation of crown & bridges, including inlays and onlays.

Fusion Bond DC is indicated for direct light cure composite or compomer restorations, core build up, and adhesive cementation of crown & bridges, including inlays and onlays.

Renew MDP is indicated for bonding of dual cure, light cure or self cure composite or compomer restorations to tooth structure. treatment of hypersensitive teeth, and intraoral repairs of fractured restorations.

Renew Universal is indicated for direct bonding of light-cured compomers to tooth structure, bonding of dual-cured core build up composites to tooth structure as long as these materials are light-cured. intraoral repair of composite, metal-based and zirconia /alumina-based restorations, intraoral repair of ceramic restorations in combination with a silane coupling agent, treatment of hypersensitive teeth, and cavity sealing as a pretreatment for indirect restorations.

Prevest Denpro Tooth Bonding Agents attach different types of restorations to teeth.

Fusion Bond 5 is a light curing single component bonding agent. It primes and bonds in one step to attach restorations of composites, copomers, amalgams, and porcelains to tooth structures. Tooth structures should have a 37% phosphoric acid etchant application of Fusion Bond 5.

Fusion Bond 7 is a light curing single component bonding agent. It etches, primes, and bonds in one step to attach restorations of composites, copomers, amalgams, and porcelains to tooth structures.

Fusion Bond DC is a dual cure bonding direct and indirect restorations. Enamel and dentin surfaces should be conditioned with 37% phosphoric acid etchant before application of Fusion Bond DC. It is a two component adhesive with bonding agent and activator.

Renew MDP is a light curing single component bondines etching, priming and bonding in one bottle. It is an ethanol-water based dental adhesive containing 10-Methacryloyloxydececyl Dihydrogen Phosphate (10-MDP) a functional monomer which helps in bonding to dentin and cut and un-cut enamel. Renew MDP works with light-cured and dual-cured composite materials.

Renew Universal is a light curing single component bondines etching, priming and bonding. Renew Universal contains a combination of functional monomers such as 10-MDP and 4-META. Renew Universal works with light-cured and dual-cured composite materials.

This document describes a 510(k) premarket notification for a series of dental bonding agents manufactured by Prevest Denpro Limited. The purpose of the 510(k) is to demonstrate substantial equivalence to legally marketed predicate devices, not to prove clinical efficacy through a comparative effectiveness study with human readers and AI assistance. Therefore, many of the requested criteria often associated with AI/ML medical devices are not applicable to this submission.

Based on the provided text, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance:

The acceptance criteria are established by the ISO 29022:2013 standard, specifically for "Dentistry - Adhesive - Notched-edge shear bond strength test." The reported device performance is stated as "Complies with ISO 29022" for both shear bond strength and curing time, with specific values provided as well.

Note: The document explicitly states "All test results met the criteria in standard." The specific numeric values (e.g., 10 MPa for Fusion Bond 5) are the reported performance, which is implicitly accepted as meeting the standard's criteria.

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 test. It states "Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP and Renew Universal were tested for appearance, shear bond strength and curing time according to protocols based on ISO 29022:2013."

The data provenance is from Prevest Denpro Limited, located in Bari Brahmana, Jammu 181133 India. The tests are presented as part of a regulatory submission, implying they were prospective tests conducted specifically for this 510(k).

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 is a physical testing submission, not a diagnostic imaging AI/ML device. Therefore, the concept of "experts establishing ground truth for a test set" in the context of medical image interpretation (e.g., radiologists) is not applicable. The ground truth is established by the physical properties measured according to an international standard (ISO 29022:2013).

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing consensus among human readers for image interpretation. This submission involves physical, objective measurements.

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

No, an MRMC comparative effectiveness study was not done. This is not an AI/ML medical device where human reader performance with and without AI assistance is relevant. This is a dental material.

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

Not applicable. There is no algorithm or AI component in these dental bonding agents. The "performance" is the physical properties of the material.

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

The ground truth for the device's performance is based on objective physical measurements conducted according to the ISO 29022:2013 standard for dental adhesives, specifically for shear bond strength and curing time. In essence, the ground truth is the scientific and engineering standard.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of machine learning for this type of device. The products are dental materials, and their formulation and manufacturing are based on established chemical and material science principles, not on iterative training data.

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

Not applicable. As there is no training set (in the ML sense), there is no ground truth to establish for it. The "ground truth" for the development of these materials would stem from principles of chemistry, material science, and prior knowledge in dental adhesive development.

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Accusil Dental Impression Material is intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums.

Accusil Dental Impression Materials are designed for dental applications to define and reproduce the structure of a patient's teeth and gums for producing crowns, bridges, occlusal models and dental implant restorative devices. Base and catalyst components are mixed in an equal ratio 1:1, placed into an impression tray and inserted into the patient's mouth. The material will conform to the patient's dentition and when set will produce a reproduction of the patient's teeth and occlusion.

The document describes the acceptance criteria and performance of Accusil Dental Impression Materials as part of a 510(k) premarket notification for FDA clearance.

Here's an analysis of the provided information, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document indicates that Accusil Dental Impression Materials were tested against specific ISO standards (ISO 4823 and ISO 48-4) and internal protocols. The "Acceptance Criteria" are implicitly derived from the requirements of these standards. The "Reported Device Performance" for Accusil is provided in the comparative table with predicate and reference devices.

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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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Micron Bioactive Class III and V. Restoration of cervical erosions and root surface caries, Core buildup. Base/Liner Class I, limited Class II, temporary fillings Restoration of primary teeth

Micron Superior Shades A1. A2. A3 Class III, Class V, limited Class I Restoration of primary teeth, Core buildup

Micron Superior Capsules Shades A1, A2, A3 Class III, Class V, limited Class I Restoration of primary teeth, Core buildup

Micron Luting

Base/Liner

Cementation of all types of metal, porcelain fused to metal, and resin crowns, inlays, and bridges Cementation of orthodontic bands Cementation of stainless steel crowns or orthodontic appliances retained with stainless steel crowns

Micron Dentin Conditioner Dentin pre-treatment prior to filling with glass ionomer cement

Micron Bioactive is a radiopaque, hydroxyapatite modified-glass ionomer cement.

Micron Superior is a radiopaque glass ionomer cement. It comes in shades A1, A2 and A3.

Micron Superior Capsules is a radiopaque glass ionomer cement. Capsules come in shades A1, A2 and A3.

Micron Luting is a radiopaque, self-curing translucent, particle glass-ionomer luting material.

Micron Dentin Conditioner is a mild polyacrylic acid solution designed to remove the dentinal smear layer and to condition dentine, thus enhancing the bond between glass ionomer cement and the dentine.

The document describes the Prevest Dental Cements, a line of dental materials including Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, and Micron Dentin Conditioner. The acceptance criteria and the study conducted to prove the device meets these criteria are detailed in the "Testing Summary" and comparison tables.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria for the Prevest Dental Cements are based on ISO 9917-1. The study reports that all test results met the criteria in Table 1 of ISO 9917-1.

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

The document does not explicitly state the sample sizes used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It only states that "Micron line products were tested" and "Shelf life testing was completed on all devices."

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

This information is not provided in the document. The testing was based on international standards (ISO 9917-1) for physical and chemical properties, not on expert clinical evaluation for ground truth.

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

This information is not applicable/provided as the testing involved laboratory measurements against a standard, not human adjudication of subjective assessments.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically relevant for AI-powered diagnostic devices involving human interpretation, which is not the nature of these dental cements.

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

This concept is not applicable to this device. These are dental cements, not an algorithm or AI system. The "standalone" testing refers to the physical and chemical property tests performed on the materials themselves, without human interpretation as part of the performance metric.

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

The "ground truth" for the performance evaluation of these dental cements is established by the specified physical and chemical properties outlined in ISO 9917-1. These are objective, measurable parameters (e.g., setting time, compressive strength, opacity) for dental materials.

8. The sample size for the training set

This information is not applicable as this is not an AI/ML device that requires a training set.

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

This information is not applicable as this is not an AI/ML device that requires a training set.

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