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Premier's MultiMatch Universal Chameleon Restorative Composite is a nano-hybrid dental restorative intended for direct placement in all cavity classes in anterior teeth. Additional indications include repair of enamel defects, repair of provisionals, and repair of porcelain restorations, minor occlusal build-ups, and incisal abrasions.

Premier's MultiMatch Universal Chameleon Restorative Composite is a light-cured, radiopaque, resin-based nanohybrid restorative composite. It is formulated for direct placement in any type of anterior and posterior cavity form. It is intended to be used with a dental bonding agent and can be sculpted prior to curing. Once light cured, the composite can be easily finished and polished to achieve a highly esthetic and durable restoration. Available in three chameleon shades, MultiMatch can be dispensed via a unit-dose capsule or syringe to provide a restoration with an excellent visual color match to the surrounding dentition.

This document is a 510(k) Summary for Premier's MultiMatch Universal Chameleon Restorative Composite. It seeks to demonstrate substantial equivalence to a predicate device, SimpliShade (K162257).

The document does not describe a study involving an AI/Machine Learning algorithm for medical image analysis or similar diagnostic purposes where an "acceptance criteria" for algorithm performance would be relevant in the way outlined in the prompt. Instead, it describes a dental restorative material and its performance testing as compared to a predicate device.

Therefore, the prompt asks for information that is not present or applicable to the provided document. The document focuses on:

• Device Description: A light-cured, radiopaque, resin-based nanohybrid restorative composite.
• Intended Use/Indications for Use: Direct placement in all cavity classes in anterior and posterior teeth, repair of enamel defects, provisionals, porcelain restorations, minor occlusal build-ups, core build-ups, and incisal abrasions.
• Technological Characteristics: Comparison of composition, curing mechanism, storage, etc., with a predicate device.
• Non-Clinical Performance Data: Mechanical strength (flexural strength, compressive strength), water sorption and solubility, depth of cure, light sensitivity, radiopacity, polymerization shrinkage, volumetric wear, and color stability, as well as biocompatibility testing.

Since this 510(k) is for a dental restorative material and not an AI-powered diagnostic device, there are no "acceptance criteria" related to AI performance metrics (like sensitivity, specificity, AUC), no "test set" of images, no "experts" establishing ground truth for AI, no "adjudication methods" for AI interpretations, no "MRMC studies," no "standalone algorithm performance," and no "training set" in the context of machine learning.

The "acceptance criteria" mentioned in the document relate to the physical and chemical properties of the composite material, tested against established ISO standards for dental materials, and comparison to the predicate device's performance.

To answer the prompt directly based on the provided text, it's necessary to state that the requested information (related to AI model acceptance criteria and study design) is not relevant to this specific premarket notification.

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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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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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