(49 days)
Metoxit blanks are indicated for use as a substructure for porcelain fused ceramic fixed dental restorations. Limitations are listed in Table 1.
Metoxit CAM-Blanks are dental ceramics, composed of yttrium-oxide stabilized tetragonal zirconium-oxide polycrystals. Metoxit CAM-Blanks are designed for the manufacturing of substructures for all-ceramic dental appliances. The dental appliance is machined either by CAD/CAM machining technique or the copying technique, then sintered to full density and strength and for the sole use of the particular patients. Metoxit CAM-Blanks are designed for the use as single tooth restorations or bridgeworks with up to two pontics in the anterior as well as in the posterior teeth region.
This document is a 510(k) Premarket Notification for Metoxit CAM-Blanks, a dental ceramic device. It seeks to demonstrate substantial equivalence to previously marketed devices rather than establishing novel performance criteria through a clinical study. Therefore, the information you've requested about acceptance criteria and a study proving the device meets those criteria, a test set, ground truth, MRMC study, and training set is not applicable in the context of this 510(k) submission.
Here's why and what is available in the document:
Purpose of a 510(k) Submission:
A 510(k) submission aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing technological characteristics, intended use, and materials. It often does not require new clinical studies to establish safety and effectiveness if the device is sufficiently similar to existing ones.
Regarding the Absence of Requested Information:
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Acceptance Criteria and Reported Device Performance (Table): Not applicable. The submission does not define new performance acceptance criteria or report specific device performance metrics in comparison to such criteria. Instead, it claims identical technological characteristics and intended use to predicate devices.
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Sample Size and Data Provenance (Test Set): Not applicable. There is no "test set" in the sense of a set of cases used for evaluating an AI algorithm's performance. The "data" here refers to the device's material properties and manufacturing process, which are compared to predicate devices. There's no clinical data or image data provenance mentioned.
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Number of Experts and Qualifications (Ground Truth for Test Set): Not applicable. No ground truth was established by experts for a test set in this kind of submission.
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Adjudication Method: Not applicable. There was no need for adjudication as no expert ratings for a test set were generated.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study would be relevant for evaluating AI-driven diagnostic or interpretative devices, which Metoxit CAM-Blanks are not. There is no mention of human readers or AI assistance.
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Standalone Performance Study: Not applicable. The device itself is a physical dental material, not a software algorithm that would have standalone performance.
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Type of Ground Truth Used: Not applicable. No "ground truth" (e.g., pathology, outcomes data) was established for an evaluation set. Safety and effectiveness are inferred from equivalence to predicate devices and their known performance.
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Sample Size for Training Set: Not applicable. This device is not an AI algorithm requiring a training set.
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How Ground Truth for Training Set was Established: Not applicable.
What the Document Does Provide (Relevant to a 510(k) Summary):
- Device Trade Name: Metoxit CAM-Blanks
- Device Common Name: CAM-Blanks
- Device Classification Name: Porcelain Powder for Clinical Use
- Intended Use: Metoxit blanks are indicated for use as a substructure for porcelain fused ceramic fixed dental restorations.
- Limitations/Indications of Use (Table 1 on page 4): This table specifies the types of restorations (single unit crowns, bridges with varying pontics) the blanks can be used for, categorized by material (TZP-A, Al-999, TZP) and process chain (porous blank or dense blank). For example, TZP-A porous blanks can be used for bridges with up to 2 pontics in both anterior and posterior regions.
- Legally Marketed Predicate Devices: K013230, K051462 - Cercon base; K051462 Cercon base colored; K050903 XAWEX G100; K022996 Vita YZ cubes; K051705 Ivoclar ZIRCAD; K052130 Vita AL cubes; K062506 Sirona InCoris AL; K001815 DCS DC-Zirkon.
- Technological Characteristics Comparison: The document explicitly states: "The technological characteristics between the predicate and proposed devices are identical. There is no difference in fundamental scientific technology. They are made from the same materials and have the same intended use."
- Conclusion of Substantial Equivalence: The submission concludes that Metoxit CAM-Blanks are as safe and effective as the predicate devices and are substantially equivalent because they share the same intended use and technological characteristics, raising no new questions regarding safety and effectiveness.
This 510(k) demonstrates "substantial equivalence" based on direct comparison of materials and intended use with existing, approved devices, rather than through new clinical performance studies against defined acceptance criteria.
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.