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510(k) Data Aggregation
(321 days)
Zircon Blanks are used for milling using digital stl-files to produce Crowns, Bridges and monolithic works. We propose the K2 Zircon Blanks for anterior and posterior restorations.
Table 1: Indication of use and maximum intermediate elements.
| Single crown | Bridges | |||
|---|---|---|---|---|
| Anterior | Posterior | Anterior | Posterior | |
| K2 Zircon Blank | ||||
| white classic | X | X | 2 | 2 |
| K2 Zircon Blank | ||||
| translucent | X | X | 2 | 2 |
| K2 Zircon Blank | ||||
| extreme translucent | X | X | 1 | - |
All K2 Zircon Blanks are indicated to be colored with Dip & Brush K2 CAD CAM Zircon Liquids. K2 Zircon Blanks should be not used by the general public or over-the-counter.
The Yeti K2 Zircon Blanks are ceramic blanks, which are indicated for the production of dentalprosthetic restorations. The blanks named above can be machined with CAM, CAD/CAM or copy milling systems commonly used in dental medical technology and for milling using digital STL files to produce Crowns, Bridges and monolithic works made from zirconium oxide.
The Yeti Dip & Brush K2 liquids are ready for use water-based products. These liquids are specifically formulated for the colorization of K2 Zircon Blanks from Yeti Dentalprodukte GmbH.
This document is a 510(k) premarket notification for a dental device, specifically Zirconium Oxide blanks used for milling dental restorations. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics (like sensitivity, specificity, or reader improvement) is not applicable to this type of submission.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present specific acceptance criteria in the form of performance thresholds (e.g., in terms of accuracy, sensitivity, or specificity) for the device itself in a study format. Instead, it demonstrates substantial equivalence to predicate devices based on:
| Characteristic | Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (K2 Zircon Blanks) |
|---|---|---|
| Chemical Composition | Comparable to predicate device (> 99.5% ZrO2 + HfO2 + Y2O3) | > 99.5% ZrO2 + HfO2 + Y2O3 |
| Shapes and Dimensions | Comparable to predicate devices | Disks (Diameter: 95 or 98.5 mm, Height: 10 to 25 mm) |
| Bulk Density | No significant deviations to predicate devices | Tested for each batch |
| Grain Size | No significant deviations to predicate devices | Tested for each batch |
| Flexural Bending Strength | No significant deviations to predicate devices | Tested for each batch |
| Fracture Toughness | No significant deviations to predicate devices | Tested for each batch |
| Hardness (Vicker's) | No significant deviations to predicate devices | Tested for each batch |
| Coefficient of Thermal | No significant deviations to predicate devices | Tested for each batch |
| Radioactivity (raw material) | No significant deviations to predicate devices | Tested for each batch |
| Solubility (acetic acid) | No significant deviations to predicate devices | Tested for each batch |
| Biocompatibility | Compliance with ISO 10993-1 standards | Tested for cytotoxicity, haemolysis, acute systematic toxicity, irritation, sensitization, pyrogen, chromosomal abbreviation and long-term implantation; all performed in accordance with ISO 10993-1. |
| Shelf Life | Established shelf-life | 10 years |
| Sintering Parameters | Identical to predicate device | 1450°C - 2 hours, 1500°C - 1 hour |
Note: The document explicitly states: "Except for the K2 Zircon Blank white classic, there was no comparable value found for the specifications translucency and Thermal conductivity" for the predicate device. This indicates that for these specific properties, direct comparison was not possible, but it doesn't indicate a failure to meet acceptance criteria, as the overall substantial equivalence argument is based on the totality of characteristics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes a 510(k) submission for a dental material (zirconium oxide blanks), not an AI/software device. Therefore, there is no "test set" in the context of an AI study for diagnostic performance. The "tests" mentioned are material property tests and biocompatibility tests.
- Sample Size: Not specified in terms of a "test set" as understood in AI studies. The performance data refers to "bench test for each raw material or product batch" and "biocompatibility evaluation." The number of samples for these tests is not quantified in the provided text, but it implies ongoing quality control and a specific evaluation for biocompatibility.
- Data Provenance: Not applicable in the context of clinical data for AI; the data refers to material testing conducted by the manufacturer, Yeti Dentalprodukte GmbH, in Germany. The biocompatibility tests were conducted according to ISO 10993-1.
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 section is not applicable. The device is a dental material, not a diagnostic device requiring expert interpretation or ground truth establishment in the diagnostic sense. The "ground truth" for material properties is established through standardized physical and chemical tests (e.g., ISO standards, lab measurements).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. There is no "test set" for diagnostic performance and no human interpretation requiring adjudication in this 510(k) submission.
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
This section is not applicable. An MRMC study is relevant for comparing human reader performance with and without AI assistance for diagnostic tasks. This device is a dental material, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. This device is a dental material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device relates to its physical, chemical, and biological properties. This is established through:
- Standardized material testing: Measurements of properties like chemical composition, bulk density, grain size, flexural bending strength, fracture toughness, hardness, coefficient of thermal expansion, radioactivity, and solubility. These are objective laboratory measurements, not subjective expert consensus.
- Biocompatibility testing against ISO standards: Compliance with ISO 10993-1, which involves specific tests for cytotoxicity, haemolysis, etc.
8. The sample size for the training set
This section is not applicable. There is no "training set" as this is a material rather than an AI or machine learning algorithm.
9. How the ground truth for the training set was established
This section is not applicable. As there is no training set for an AI algorithm, the concept of establishing ground truth for it is irrelevant in this context.
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(262 days)
The Straumann CARES M-Series CAD/CAM System is indicated for the design and fabrication of single or multiple-unit implant-borne prosthetics for the restoration of partially or fully edentulous mandibles and maxillae. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners or Extra-Oral Scanners, CAD software, CAM software, restoration material blanks, milling machines and associated tooling and accessories. The system is used to design and fabricate CAD/CAM milled coping, crown and bridge restorations to be cemented onto Straumann® Variobase® Abutments, as well as milled abutments to be affixed to the endosseous dental implants of the Straumann® Dental Implant System using a basal screw.
The Straumann CARES M-Series CAD/CAM System is intended for the design and fabrication of dental restorations by dental laboratories by means of a digital workflow. The Straumann CARES M-Series CAD/CAM System employs optical impression files that document the topographical characteristics of teeth, traditional dental impressions, or stone models. The Straumann CARES Visual CAD software then allows the design of the desired restorations. The CAM software converts the digital restoration design into the tooling and tool path commands needed to fabricate the restoration. The CAM software also allows multiple restoration files to be combined (nested) in order to maximize the use of dental material blanks. The milling command file is encrypted prior to transfer to the M-Series mill; this encryption ensures that files generated using other CAD or CAM software cannot be used with the M-Series mill. The user will load the milling command file into the M-Series mill where it is decoded. The user loads the appropriate dental material blank and initiates the milling operation.
The provided document describes the acceptance criteria and the study that proves the Straumann CARES M-Series CAD/CAM System meets those criteria, primarily through a substantial equivalence comparison with predicate devices and various bench studies.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical targets in the document. Instead, performance is demonstrated through a claim of "equivalence" to predicate devices, which implicitly means meeting the performance standards of those legally marketed devices. The reported device performance is presented as "Equivalent" for various features when compared to predicate devices.
| Feature / Acceptance Criteria | Reported Device Performance (Equivalence Discussion) |
|---|---|
| Indications for Use (Straumann CARES M-SERIES CAD/CAM System vs. SIRONA DENTAL CAD/CAM SYSTEM) | Equivalent: The basic indication of providing support for prostheses scanning, design, and fabrication is the same. Support for TiBase-borne restorations is the same. The subject device indications refer to fabrication of coping, crowns, and bridges, including mesostructures (top-half of two-piece abutment), which are the same as referenced in the primary predicate indications. The crowns and bridges of the subject device are considered equivalent to hybrid abutments. The subject device also supports the fabrication of implant-connected solid abutments. This implies its performance meets the predicate for all these restoration types. |
| Source of Input Files | Equivalent: Capabilities of the subject device (Intra-Oral Scanner, Bench-top Scanners) include the scope of capabilities for the predicate device (Bench-top scanners). |
| Bench Scanner Control | Equivalent |
| Implant Detection | Equivalent: Both use Scanbodies. |
| Design Environment | Equivalent: Both are Closed CAD Systems facilitating the design of restorations, but for devices from different companies. Performance is considered equivalent in terms of design functionality. |
| Restoration Types Supported | Equivalent: Capabilities of the subject device (Copings/Crowns for Variobase, Copings/Crowns/Bridges for Screw-Retained Abutments, Bridges/Bars for Variobase for Bridge/Bar, Solid TAN Abutments) include the scope of capabilities for the predicate device (Copings/Crowns for TiBase, Copings/Crowns for Camlog Titanium Base). Both allow design and fabrication of the mesostructure for two-piece abutments (standard coping or hybrid crown/bridge). The subject device also allows design and fabrication of a one-piece titanium abutment. The areas of the abutment available for design are equivalent. |
| Supported Hardware Devices | Equivalent: Capabilities of the subject device (Straumann Variobase Abutments, Straumann Screw-Retained Abutments, Solid abutments) include the scope of capabilities for the predicate device (Sirona Ti-bases, Camlog Titanium Base). The subject devices provide support for implant-connected abutments. |
| Supported Restorative Materials | Equivalent: ZrO2 Ceramic material with indications according to ISO 6872 Classification are equivalent. The ZrO2 materials for use with the Straumann CARES M-Series CAD/CAM System have been previously cleared by FDA. The TAN material is identical to material used in CARES TAN Abutments (K150899). Straumann n!ce Blocks for Amann Girrbach were previously cleared (K170420). The use of the Ivoclar IPS e.max CAD material with Variobase Abutments has been cleared (K142890). The use of the n!ce material with Variobase Abutments has been cleared (K170354). This implies the milling performance and material properties for these materials meet prior predicate standards. |
| Restoration Sizes | Equivalent: Capabilities of the subject device (Single crown up to 16-Unit bridge) include the scope of capabilities for the predicate device (Single crown). Support of bridges through two or more implants is achieved through Variobase for Bridge/Bar abutments (K151157). Use of multiple implants in the bridge limit the force on the individual implant to be less or equivalent to that of the single crown. For a 16-unit bridge, the force is spread over 4 or more implants. |
| Interface to Ti-Base | Equivalent: The ability of the subject device to use solid blocks provides greater design flexibility to the user (compared to predicate's pre-milled blocks). |
| CAD to CAM Transfer | Equivalent: Seamless, same software interface. |
| CAM Capability | Equivalent: Capabilities of the subject device (Nesting, selection of tools/paths/speeds/feed rates, encryption) include the scope of capabilities for the predicate device (selection of tools/paths/speeds/feed rates). |
| CAM to Mill Transfer | Equivalent: Capabilities of the subject device (encrypted file format ensuring only Straumann CARES Visual and CAM Module files are accepted) include or exceed the scope of capabilities for the predicate device (expected transfer encryption). |
| Supported Mills | Equivalent: Capabilities of the subject device (Straumann CARES M-Series Mills) include the scope of capabilities for the predicate device (CEREC MCXL Mill, inLab MCXL Mill). |
| Fabrication Workflow | Equivalent: Capabilities of the subject device (Dry milling of partially crystallized ceramic, Wet milling of Ti-6Al-7Nb Pre-Milled Abutment Blanks, Ivoclar IPS e.max CAD, and n!ce Glass Ceramic) include the scope of capabilities for the predicate device (In-lab wet milling of pre-sintered ceramic blocks). |
| Variobase Abutments: Indications for Use | Identical to predicate Straumann Variobase Abutments (K142890, K120822). |
| Variobase Abutments: Ti-base Material | Identical: Titanium-Aluminum-Niobium alloy (Ti-6Al-7Nb). |
| Variobase Abutments: Abutment Diameter | Identical: 3.8 – 7.0 mm. |
| Variobase Abutments: Abutment Height | Identical: 3.5 – 4.5 mm. |
| Variobase Abutments: Coping/Crown Material | Equivalent/Identical: Digital workflow is expanded to add additional materials (Ceramill ZOLID series, Ivoclar IPS e.max CAD, Straumann n!ce). The Zi, ZOLID series are equivalent to predicate's zerion ZrO2 material. Use of n!ce and IPS e.max CAD is identical to previously cleared devices. |
| Variobase Abutments: Design Workflow | Equivalent: Subject employs a subset of predicate's techniques (CAD vs. Wax-up or CAD). |
| Variobase Abutments: Fabrication Workflow | Equivalent: Restorations milled by the dental laboratory are equivalent to those produced by the Straumann milling center. |
| Variobase Abutments: Mode of Attachment | Identical: Screw-retained or cement retained. |
| Variobase Abutments: Reusable | Identical: No. |
| Laboratory Milled CARES® TAN Abutments: Indications for Use | Identical to predicate Straumann® CARES® TAN Abutments (K150899). |
| Laboratory Milled CARES® TAN Abutments: Abutment Material | Identical: Titanium-Aluminum-Niobium alloy (Ti-6Al-7Nb, TAN). |
| Laboratory Milled CARES® TAN Abutments: Abutment Apical Design | Identical: Engaging, BoneLevel (NC, RC), Tissue Level (RN, WN). |
| Laboratory Milled CARES® TAN Abutments: Abutment Coronal Design | Identical: CADCAM design process, designs controlled by material-specific design limits in CARES Visual CAD software, model verification by CAM software, and milling blank dimensions. |
| Laboratory Milled CARES® TAN Abutments: CAD Design Limits | Identical: Max. Angulation 30°, Emergence Offset 0.1 mm, Emergence Angle 65°, Min. Thickness 0.4 mm, Smooth Distance 0.5 mm, Min post surface area 37 to 56mm². |
| Laboratory Milled CARES® TAN Abutments: Fabrication Method | Equivalent: Both methods use Straumann CARES Visual CAD software for design, applying the same validated limits. The difference is the manufacturing location (QSR controlled vs. dental laboratory). The milling accuracy of the Straumann CARES M-Series CAD/CAM System has been validated. Labeling has been revised and validated for milling unit installation, maintenance, and required tools/machine liquids/material blocks to ensure equivalence. |
| Laboratory Milled CARES® TAN Abutments: Directly Veneerable? | Identical: Yes. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" sample size in the context of clinical studies with patients. The studies conducted are primarily bench studies involving laboratory testing of materials and device components. The number of samples for each type of bench test (fatigue, biocompatibility, etc.) is not detailed in this summary, but these are typically standardized tests with a defined number of specimens as per the relevant ISO or FDA guidance.
The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective" clinical data, as it primarily refers to bench testing data. These tests would have been performed in a controlled laboratory environment.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not applicable. The evaluations are based on engineering and material performance specifications (bench studies) and comparison to predicate devices, not on expert clinical review of a test set for establishing ground truth in a diagnostic sense.
4. Adjudication Method for the Test Set
This information is not applicable, as the evaluation is based on bench testing and comparison to technical specifications, not human adjudication of diagnostic data.
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
This information is not applicable. The device is a CAD/CAM system for fabricating dental prosthetics, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study related to improving human reader performance with AI is not relevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The document describes the Straumann CARES M-Series CAD/CAM System as an integrated system involving CAD software, CAM software, milling machines, and material blanks. The "algorithm" component is the CAD/CAM software. The system's performance is inherently "standalone" in its function of designing and fabricating prosthetics based on input scan files, but it is a tool used by human operators (dental technicians/laboratories). The bench studies performed evaluate the output of this system (e.g., strength of the milled prosthetics), which indirectly assesses the standalone performance of the algorithms and hardware in creating the physical restorations.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
For the bench studies, the "ground truth" refers to established engineering and material standards. Specifically:
- Dynamic fatigue testing: Conforming to FDA guidance and ISO 14801. The ground truth is the performance criteria defined by these standards.
- Software validation: Conforming to the requirements of IEC 62304. The ground truth is compliance with this software safety standard.
- Sterilization validation: Conforming to ISO 17665-1 and ISO/TS 17665-2. The ground truth is achieving sterility assurance levels defined by these standards.
- Biocompatibility testing: Conforming to ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, and ISO 10993-18. The ground truth is meeting the safety criteria for biological interaction.
- Electrical safety testing: Conforming to IEC 61010-1 and IEC 61010-2-010. The ground truth is compliance with electrical safety standards.
For the substantial equivalence comparison, the "ground truth" is the performance and characteristics of the legally marketed predicate devices.
8. The Sample Size for the Training Set
The document does not refer to a "training set" in the context of machine learning. The CAD/CAM software is likely based on computational design and manufacturing principles, not on a machine learning model that requires a labeled training set derived from large datasets of past cases. Therefore, this concept is not applicable here.
9. How the Ground Truth for the Training Set was Established
As there is no "training set" in the machine learning sense, this question is not applicable. The underlying principles for the software's functionality would stem from dental anatomical knowledge, engineering mechanics, material science, and manufacturing tolerances, which form the basis of its deterministic operation.
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