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Premier Etch is a prescription- only, 37% phosphoric acid etchant in a gel form that is used by the dental professional for etching dentin or enamel prior to tooth restoration.

Premier Etch is a prescription- only, 37% phosphoric acid etchant in a gel form.

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any study details. It is a 510(k) clearance letter from the FDA for a dental etching product, "Premier Etch," confirming its substantial equivalence to legally marketed predicate devices. The letter primarily addresses regulatory compliance and device classification.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on this document.

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Knit-Pak+, a prescription-only, Aluminum Chloride Hexahydrate impregnated cord is used for temporary chemo-mcchanical retraction of gingival tissues and hemostasis of the gingival margin around the tooth. It is intended for accurate and enhanced results when acquiring dental impressions, for cavity preparation or wherever hemostasis and retraction is required.

Knit-Pak+, a prescription-only, Aluminum Chloride Hexahydrate impregnated cord

The provided text is a 510(k) premarket notification letter from the FDA regarding a dental product named "Knit-Pak+". This document is a regulatory approval letter and does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls. It also outlines regulatory responsibilities for the company.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text. The requested information regarding sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information is not present in this document.

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Premier Ceramic Primer is a prescription-only, one-step silane coupling agent intended for preparation of ceramic materials such as porcelain, ceramic, hybrid ceramic or composite resin and zirconia restorations designed to improve adhesion to resin materials prior to cementation or restoration. This primer does not require prior sandblasting or the use of an etchant.

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I am sorry, but the provided text only contains regulatory correspondence from the FDA regarding a 510(k) premarket notification for the "Premier Ceramic Primer." It discusses the device's classification, general controls, and indications for use.

However, the document does not contain any information about acceptance criteria, study design, reported device performance, sample sizes, data provenance, expert qualifications, ground truth establishment, or any comparative effectiveness studies (MRMC or standalone).

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

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Ask a specific question about this device

To be used for cleaning and polishing procedures as part of a professionally administered prophylaxis treatment.

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The provided text is a 510(k) premarket notification letter from the FDA regarding a dental product named "Enamel Pro." This document does not contain any information about acceptance criteria or a study proving that a device meets such criteria.

The letter's purpose is to inform the manufacturer that their device has been found substantially equivalent to legally marketed predicate devices, allowing them to market it. It discusses regulatory classifications, general controls, and compliance requirements, but it does not detail any performance studies, acceptance criteria, or specific performance metrics for the Enamel Pro device.

Therefore, I cannot provide the requested information based on the input text.

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Enamel Pro® Varnish is a fluoride containing preparation for the treatment of dentinal hypersensitivity, and for the reduction of post operative sensitivity. The varnish can be placed on sensitive root surfaces and under temporary restoratives and cements in order to seal exposed dentinal tissue. It can be used as a cavity liner.

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I am sorry but this document does not contain the information you are looking for. The document is an FDA clearance letter for a dental varnish (Enamel Pro® Varnish) and focuses on its substantial equivalence to a legally marketed predicate device, rather than detailed acceptance criteria and a study proving device performance as typically expected for imaging or AI-driven medical devices.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for a test set or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for a test set.
5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Information on a standalone AI algorithm performance study.
7. The type of ground truth used.
8. The sample size for the training set.
9. How ground truth for the training set was established.

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Premier Self-Etching Enamel Sealant is for the preventive sealing of pits and fissures in the primary and secondary dentition, utilizing the self-etching technique. Secondarily, the material can be used as a sealant/lining under amalgam restorations.

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I am sorry, but the provided text does not contain the information required to answer your request about acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for a dental sealant and does not include details about device performance studies, sample sizes, ground truth establishment, or expert qualifications.

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Premier Self-Etching Bond Enhancer is a no-rinse multi-purpose adhesive primer and bond coupling agent designed to work with existing bonding agents. When used with dental bonding agents, Premier Self-Etching Bond Enhancer can be used for bonding composite to enamel and/or dentin, composite repair, porcelain repair, composite to metal, bonding composite core build-up material and for bonding veneers, onlays and inlays.

Premier Self-Etching Bond Enhancer is a no-rinse multi-purpose adhesive primer and bond coupling agent designed to work with existing bonding agents.

This document is a 510(k) clearance letter from the FDA for a dental bonding agent. It does not contain information about acceptance criteria or a study proving device performance in the context of AI/ML or diagnostic devices.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set size. This type of information is typically found in clinical study reports or performance data sections of 510(k) submissions, which are not included in this regulatory letter.

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Premier Temporary Cement is recommended for the cementation of temporary crowns, bridges, inlays and onlays.

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This looks like a 510(k) clearance letter for a dental cement, not an AI/ML device. Therefore, the requested information about acceptance criteria, clinical study design, ground truth establishment, expert adjudication, and comparative effectiveness studies is not applicable.

The document discusses substantial equivalence to a predicate device based on regulatory requirements for dental cements, not performance metrics of an AI algorithm.

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Cementation of Gutta-Percha in root canal using the single cone technique.

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This document is a 510(k) clearance letter from the FDA for a dental cement, Premier EndoCem Glass Ionomer Cement, and does not contain the detailed study information typically found in a clinical study report or a premarket approval (PMA) application. Therefore, most of the requested information regarding acceptance criteria, device performance, study design, and ground truth establishment is not available in this document.

The primary purpose of this letter is to state that the FDA has determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

Here's what can be extracted, and what is explicitly not available:

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

• Not available in this document. The FDA letter grants clearance based on "substantial equivalence" to a predicate device, meaning it performs as safely and effectively as a similar device already on the market. It does not provide specific performance metrics or acceptance criteria for a new study.

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

• Not available in this document. This letter does not describe any specific test set or study methodology.

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):

• Not available in this document.

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

• Not available in this document.

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 and not available. This device is a dental cement, not an AI-powered diagnostic tool. MRMC studies are used for evaluating diagnostic imaging systems with human readers.

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

• Not applicable and not available. Again, this is a physical dental cement, not an algorithm.

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

• Not available in this document. If a comparison was made for substantial equivalence, it would likely involve in vitro testing or perhaps clinical data demonstrating similar mechanical properties, biocompatibility, or sealing capabilities to the predicate device. The exact "ground truth" for showing equivalence is not detailed here.

8. The sample size for the training set:

• Not applicable and not available. There is no mention of a "training set" as this is not an AI/machine learning device.

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

• Not applicable and not available.

Summary of available information related to the device:

• Device Name: Premier EndoCem Glass Ionomer Cement
• K Number: K042215
• Regulation Number: 21 CFR 872.3275(b)
• Regulation Name: Dental Cement
• Regulatory Class: II
• Product Code: EMA
• Indications for Use: Cementation of Gutta-Percha in root canal using the single cone technique.

To obtain the detailed information requested, one would typically need to review the original 510(k) submission (which is usually not publicly available in its entirety due to proprietary information) or a specific clinical study report if one was conducted and published. The FDA clearance letter itself is a summary of their decision, not the full scientific dossier.

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