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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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