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Luminesse ZR Blanks are intended for CAD/CAM fabrication of all-ceramic ( no metal ) dental restorations. Luminesse ZR Blanks are partially sintered Yttria stabilized zirconia blanks for use as CAD/CAM milling blanks. They are isostatically cold pressed so they can be milled using any compatible CAD/CAM machine such as Sirona InLab by Sirona Dental Systems, LLC, Charlotte, NC or KaVO Everest by KaVo Dental, Lake Zurich, IL.

After the ZR Blank is milled, it is sintered, causing the materials to densify into a high strength ceramic material which is suitable for dental inlays, onlays, crowns and bridges.

Luminesse Zirconia blanks, are high purity, bisque fired zirconia machining blanks. The powders pressed to form these blanks are of a uniform size and well dispersed, ensuring no agglomerates. The resultant fine grained, bisque body allows intricate shapes to be machined with tight tolerances. Luminesse Zirconia blanks are phase stabilized with 3 mol % yttria and therefore do not undergo the usual phase transitions associated with pure zirconia. This phase transformation "toughens" the zirconia and stops crack propagation, yielding high fracture toughness and high strength. The highest purity powders are used to make Luminesse Zirconia Blanks minimizing trace oxides. Luminesse Blanks are 99.9 wt% ZrO 2+ Y20 3 + HfO2 + A1203. The natural zirconia minerals HfO2, which is so similar in structure and chemical properties to zirconia, that it has no effect on product properties. A small addition of alumina minimizes hydrothermal aging.

Luminesse Zirconia Blanks are dental ceramic blanks designed for the manufacturing of substructures for ceramic dental appliances. The dental appliance is machined either by CAD/CAM machining or using the copying technique. All appliances are for the sole use of the particular patient only. A metal chuck is glued on the end of blank or a metal ring that holds it in the CAD/CAM machine which is used to machine the final dental restoration. After completion of the machining steps, the dental restoration is fired (i.e., sintered) in the oven to harden the ZrO 2.

Luminesse ZR Blanks are intended for CAD/CAM fabrication of all-ceramic ( no metal ) dental restorations. Luminesse ZR Blanks are partially sintered Yttria stabilized zirconia blanks for use as CAD/CAM milling blanks. They are isostatically cold pressed so they can be milled using any compatible CAD/CAM machine such as Sirona InLab by Sirona Dental Systems, LLC, Charlotte, NC or KaVO Everest by KaVo Dental, Lake Zurich, IL.

After the ZR Blank is milled, it is sintered, causing the materials to densify into a high strength ceramic material which is suitable for dental inlays, onlays, crowns and bridges.

The provided text describes a 510(k) summary for "Luminesse Zirconia Blanks," which are dental ceramic blanks for manufacturing substructures for ceramic dental appliances. This submission argues for substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a new device's functionality. Therefore, many of the requested points related to device performance studies, ground truth, and expert evaluation are not directly applicable or provided in this document.

Here's an analysis based on the provided text:

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

The document does not present specific acceptance criteria for device performance for Luminesse Zirconia Blanks. Instead, it states that the predicate device, IPS e.max ZirCAD by Ivoclar (K051705), used the Biaxial Performance Criteria: Strength method to test Flexural Strength (ISO 6872) and Chemical Solubility for mass loss (ISO 6872) using a 4% solution of acetic acid.

The submission claims that "Since the predicate and proposed devices are exactly identical in formulation, there is no need for further testing." This implies that the Luminesse Zirconia Blanks are expected to perform comparably to the predicate device, meeting the same (unspecified in this document) performance criteria as evaluated for the predicate device.

Table of (Implied) Acceptance Criteria and Reported Device Performance:
(Based on the predicate device's testing and the claim of identical formulation)

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

No specific test set or data provenance is mentioned for the Luminesse Zirconia Blanks as direct testing was not conducted. The reliance is on the predicate device's data.

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 applicable. No ground truth establishment by experts for a test set is mentioned for the Luminesse Zirconia Blanks. The basis for equivalence is material composition.

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

Not applicable. No adjudication method for a test set is mentioned.

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 device is a material for dental restorations, not an AI or imaging diagnostic tool that would involve human readers or AI assistance.

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

Not applicable. This device is a material, not an algorithm.

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

Not applicable. The "ground truth" in this context is the performance of the predicate device based on standardized material testing (ISO 6872).

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. This is not an AI/machine learning device.

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Intended for use in preparation of crowns, facings, inlays and onlays--to produce a hard prosthesis with a porcelain-like finish. Frequently used with porcelain overlay for translucence and related effects. For fabricating copings and frameworks for inlays, onlays, veneers, crowns, anterior and posterior bridge restorations.

Intended to restore carious lesions or structural defects in teeth. It is intended for use in cavities Classes I, II, and V (inlays and onlays) and as a restorative material intended for veneers, crowns and bridges.

PSL BioZir Block™ is a zirconium dioxide-yttrium oxide ceramic, capable of machining by modern methods. PSL BioZir Block™ (when it reaches the dentist, like opercelain "powder" prepared by the laboratory into an inlay or onlay, or as a bridge or crown) is a finished device ready for installation. The dentist prepares the tooth surfaces, sends a properly prepared impression of those surfaces to the dental laboratory where it is scanned and an inlay, onlay, or crown inprepsived or modern computerized lathe methods and returned to the dentist then prepares the final tooth surfaces involved and cements (lutes) the prosthesis in place with standard departs adle timal (luting) materials. PSL BioZir Block™ prostheses are alternatives to gold, amalgam, ceramic, porcelain, or composite filling materials, more closely resembling gold inlays or porcely inlays, onlays or veneers in that they are actually prepared in a dental laboratory. The material is radio-onage, for ready visualization.

The provided 510(k) summary does not contain information about acceptance criteria or a study demonstrating the device's performance against such criteria. This document describes a dental restorative material, PSL BioZir Block™, and establishes its substantial equivalence to previously cleared devices based on intended use, technological characteristics, and material composition.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, study details, sample sizes, ground truth, or expert involvement, as this information is not present in the provided text.

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Intended for use in preparation of crowns, facings, inlays and onlays--to produce a hard prosthesis with a porcelain-like finish. Frequently used with porcelain overlay for translucence and related effects. For fabricating copings and frameworks for inlays, onlays, veneers, crowns, anterior and posterior bridge restorations.

Intended to restore carious lesions or structural defects in teeth. It is intended for use in cavities Classes I, II, and V (inlays and onlays) and as a restorative material intended for veneers, crowns and bridges.

Zirl3lank-PS and ZirBlank-FS is a yttrium oxide-stabilized zirconia (Y-ITZP) capable of machining by modern methods. The dentist prepares the tooth surfaces, sends a properly prepared impression of those surfaces to the dental laboratory where it is scanned and an inlay, onlay or other prosthesis is prepared by modern computerized lathe methods and returned to the dentist. The dentist then prepares the final tooth surfaces involved and cements (lutes) the inlay or onlay in place with standard dental adhesives (luting) materials. ZirBlank-PS and ZirBlank-FS prostheses are alternatives to gold, amalgam, ceramic, porcelain, or composite filling materials, more closely resembling gold inlays or porcelain inlays, onlays or veneers in that they are actually prepared in a dental laboratory. The material is radio-opaque, for ready visualization.

This submission does not contain information about an AI/ML device or a medical device that would have acceptance criteria and a study to prove it meets them in the typical sense of diagnostic performance metrics (e.g., sensitivity, specificity).

The document is a 510(k) summary for a dental restorative material, ZirBlank-PS and ZirBlank-FS, which are yttrium oxide-stabilized zirconia (Y-TZP) powders/blocks. The purpose of a 510(k) submission for such a device is to demonstrate substantial equivalence to legally marketed predicate devices, not to prove diagnostic performance.

Therefore, I cannot extract the requested information (acceptance criteria, device performance, sample sizes for test/training, expert details, adjudication methods, MRMC studies, standalone performance, or ground truth types) because this type of evaluation is not applicable to this particular device and its regulatory submission.

The "study" mentioned in the document refers to the demonstration of substantial equivalence based on:

1. Same intended use as predicate devices.
2. Similar technological characteristics, with well-understood differences.
3. Well-established materials (components of ZirBlank-PS and ZirBlank-FS have prior successful use in legally marketed devices, including hip implants).
4. Comparison to predicate devices for safety and effectiveness.

The "acceptance criteria" here are implicitly satisfying the FDA's requirements for substantial equivalence, primarily by demonstrating that the device is as safe and effective as predicate devices. The performance is assessed by material properties and intended use, not by diagnostic accuracy.

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Intended for use in preparation of crowns, facings, inlays and onlays-to produce a hard prosthesis with a porcelain-like finish. Frequently used with porcelain overlay for translucence and related effects. For fabricating copings and frameworks for inlays, onlays, veneers, crowns, anterior and posterior bridge restorations. The suitability of high purity dense yttria tetragonal zirconium oxide has been well demonstrated for many uses in the dental industry. Intended to restore carious lesions or structural defects in teeth. It is intended for use in cavities Classes I, II, and V (inlays and onlays) and as a restorative material intended for veneers, crowns and bridges.

Sagemax Z-Blank™ is a zirconium dioxide-yttrium oxide ceramic, capable of machining by modern methods. The dentist prepares the tooth surfaces, sends a properly prepared impression of those surfaces to the dental laboratory where it is scanned and an inlay or onlay prepared by modern computerized lathe methods and returned to the dentist. The dentist then prepares the final tooth surfaces involved and cements (lutes) the inlay or onlay in place with standard dental adhesives (luting) materials. Sagemax Z-Blank "" prostheses are alternatives to gold, amalgam, ceramic, porcelain, or composite filling materials, more closely resembling gold inlays or porcelain inlays, onlays or veneers in that they are actually prepared in a dental laboratory. The material is radio-opague, for ready visualization.

The provided K062695 document for Sagemax Z-Blank™ is a 510(k) Premarket Notification for a dental restorative material. The purpose of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device (or devices). This is not a study that proves a device meets acceptance criteria in the way a clinical trial or performance study would for, for instance, an AI/ML medical device.

Key takeaway for your request: This document focuses on demonstrating substantial equivalence to existing predicate devices based on intended use, technological characteristics, and descriptive information about the material. It does not contain the type of performance study data, acceptance criteria tables, sample sizes, or expert ground truth information that would be found in a submission for a novel device or an AI/ML-driven device.

Therefore, I cannot extract the specific information you requested in points 1-9 for this document because it is not present. The document explicitly states:

• "The successful prior use of the components of Sagemax Z-Blank™ product in legally marketed devices, the similarity of the formulations used in this device and earlier devices, and the substantially equivalence of Sagemax Z-Blank to prior cleared devices support the safety and effectiveness of the Sagemax Z-Blank™ product for the intended use."
• "These products have the same intended use..."
• "The technological characteristics for this product are similar to those for the 2. The technological ohose currently on the market except for slight differences in predicate donood and the technological differences are well understood in the mothous of too."

This indicates that the submission relies on the established safety and effectiveness of predicate devices and the material's well-known properties, rather than new performance studies with specific acceptance criteria that would require test sets, ground truth, and expert adjudication.

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For fabricating copings and frameworks for inlays, onlays, veneers, crowns, anterior and posterior bridge restorations. The suitability of high purity dense yttria tetragonal zirconium oxide has been well demonstrated for surgical implant and more recently for many uses in the dental industry.

Intended for preparation of crowns, facings, inlays and onlays--to produce a hard prosthesis with a porcelain-like finish. Frequently will be used with porcelain overlay for translucence and related effects.

Intended to restore carious lesions or structural defects in teeth. It is intended for use in cavities Classes I, II, and V (inlays and onlays) and as a restorative material intended for veneers, crowns and bridges.

Medin Tech Zirconia™ is a zirconium dioxide-yttrium oxide ceramic, capable of machining by modern CAD/CAM methods. The dentist prepares the tooth surfaces, sends a properly prepared impression of those surfaces to the dental laboratory where it is scanned and an inlay or onlay prepared by modern computerized lathe methods and refurned to the dentist. The dentist then finally prepares the tooth surfaces involved and cements (lutes) the inlay or onlay in place with standard dental adhesives (luting) materials. Medin Tech Zirconia" prostheses are alternatives to gold, amalgam, ceramic, porcelain, or composite filling materials, except that their application more closely resembles gold inlavs or porcelain inlays, onlays or veneers in that they are actually prepared in a dental laboratory. The material is radio-opaque, for ready visualization.

This 510(k) summary does not contain information about acceptance criteria or a study proving the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices already on the market.

Here's why and what information is missing:

• Device Type: The device, "Medin Tech Zirconia," is a dental restorative material (porcelain powder/blocks). For such materials, the "acceptance criteria" and "study" would typically refer to physical and chemical properties (e.g., strength, biocompatibility, wear resistance, dimensional stability, bond strength) and in-vitro or potentially short-term in-vivo studies demonstrating those properties meet established standards or are comparable to predicate devices.
• 510(k) Process for Substantial Equivalence: The document explicitly states it followed the "510(k) 'Substantial Equivalence' Decision-Making Process." This means the primary argument for clearance is that the new device is as safe and effective as a legally marketed predicate device, not necessarily that it meets a specific set of predefined performance acceptance criteria through clinical trials or extensive standalone studies in the same way a novel diagnostic or therapeutic AI device might.
• Focus of the Document: The document primarily details:
  • Device description and intended use.
  • Identification of predicate devices (Cynovad Zirkon, Denzir, Cercon Base, Vita Cerec Blocks, Dicor Ceramic Inlay, Finesse All-Ceramic System, Dental Ceramic for Fabrication).
  • Arguments for substantial equivalence based on identical intended use, similar technological characteristics, and well-established materials.

Therefore, it is impossible to provide the requested table and details because the provided text does not contain this type of information. The 510(k) summary for this type of device does not typically include clinical study data in the way a diagnostic AI device's submission might.

If this were a diagnostic AI device, the missing information would be crucial for evaluating its performance. However, for a dental restorative material like zirconia powder, the "proof" often comes from material testing data comparing it to existing, cleared materials, and the FDA's acceptance of its substantial equivalence.

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Intended for preparation of crowns, facings, veneers, inlays and onlays--to produce a hard prosthesis with a porcelain-like finish.

For fabricating copings and frameworks for inlays, veneers, crowns, anterior and posterior bridge restorations.

Intended to restore carious lesions or structural defects in teeth. It is intended for use in cavities Classes I, II, and V (inlays and onlays) and as a restorative material intended for veneers, crowns and bridges.

Cynovad Zirkon™ is a zirconium dioxide-yttrium oxide ceramic, capable of machining by modern methods. The dentist prepares the tooth surfaces, sends a properly prepared impression of those surfaces to the dental laboratory where it is scanned and an inlay or onlay prepared by modern computerized lathe methods and returned to the dentist. The dentist then finally prepares the tooth surfaces involved and cements (lutes) the inlay or onlay in place with standard dental adhesives (luting) materials. Cynovad Zirkon™ inlays are alternatives to gold, amalgam, ceramic, porcelain, or composite filling materials, except that their application more closely resembles gold inlays or porcelain inlays, onlays or veneers in that they are actually prepared in a dental laboratory. The material is radio-opaque, for ready visualization.

This submission describes a dental restorative material, "Cynovad Zirkon™", which is a zirconium dioxide-yttrium oxide ceramic used to create inlays, onlays, veneers, and crowns. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than reporting on a study with specific acceptance criteria and performance metrics for the device itself.

Therefore, many of the requested sections (Table of acceptance criteria and performance, sample size for test set, number of experts, adjudication method, MRMC study, standalone study, ground truth type and training set information) cannot be extracted from the provided text as the information is not present.

Here's a breakdown of what can be inferred or stated from the provided document:

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

The document does not specify quantitative acceptance criteria or performance metrics for the Cynovad Zirkon™ device. The entire submission is based on demonstrating substantial equivalence to legally marketed predicate devices, meaning its performance is considered acceptable if its technological characteristics and intended use are similar to those already cleared.

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

Not applicable. There is no mention of a dedicated "test set" or a study designed to measure performance against specific criteria. The submission relies on a comparison to predicate devices.

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 applicable. No ground truth establishment for a test set is described.

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

Not applicable. No adjudication method is mentioned as there is no human review of a test set described in the context of performance evaluation.

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 device is a material for dental restorations, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reader improvement with AI is not relevant.

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

Not applicable. This device is a material, not an algorithm.

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

Not applicable. The basis for clearance is substantial equivalence to predicate devices, not direct comparison to a clinical ground truth established through expert consensus, pathology, or outcomes data for the Cynovad Zirkon™ itself. The "ground truth" in this context is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable. As a material, there is no "training set" in the context of algorithm development.

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

Not applicable. See point 8.

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