(109 days)
Bittar Zirconia Blocks are indicated for use as a substructure for ceramic dental restorations. All blanks are solely by or on the order of a dental professional. They are not for use by the general public or over-the-counter.
Bittar Zirconia Blocks are an all ceramic core material made of high bisque fired Zirconia Oxide (ZrO2), and are provided in either block, rod or disk shape. CAD/CAM fabrication of the core material can then be used to produce copings and / or substrates for fixed all ceramic dental restorations above the gum line. The material is used for the manufacturing of inlays, onlays, veneers, crowns and bridges. The material is then fired in an oven to harden the ZrO2 The milling and final oven hardening process (i.e., sintering) is completed by the end user.
This submission (K082652) is for a dental material (Bittar Zirconia Blocks) and not a medical device software or AI. Therefore, the requested information regarding acceptance criteria and studies proving the device meets those criteria, particularly in the context of AI performance, is not available within this document. The submission focuses on demonstrating substantial equivalence to predicate devices for a physical material.
Specifically, the document states:
- "By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device, or has the same intended use and different technological characteristics. But, it can be demonstrated that the device is as safe and effective as the predicate device and the new device does not raise different questions regarding safety and effectiveness as compared to the predicate device."
- "As such, it has been shown in this 510(k) submission, that the differences between the Bittar Zirconia Blocks and the predicate devices do not raise any questions regarding their safety and effectiveness."
- "The Bittar Zirconia Blocks as designed and manufactured are as safe and effective as the predicate device and therefore are determined to be substantially equivalent to the referenced predicate device."
Since this is a substantial equivalence claim for a physical dental material, complex performance metrics, AI-specific studies, or human reader comparisons are not relevant or provided. The "study" here is the demonstration of equivalence to existing devices based on material properties and intended use.
§ 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.