(48 days)
HeraCeram Press dental ceramic compound is intended for use with the veneering ceramic material HeraCeram. It can be used for full ceramic restorations with the common layering technique as well as the staining technique. Applications: Veneers, Inlays, Onlays and Crowns.
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The provided text is a 510(k) premarket notification letter from the FDA to Heraeus Kulzer, Incorporated, regarding their device "HeraCeram Press." It primarily discusses the substantial equivalence determination for this dental ceramic compound.
This document does not contain any information about acceptance criteria, device performance metrics, study designs, sample sizes, expert qualifications, ground truth establishment, or clinical study results (such as MRMC or standalone performance). The letter is a regulatory approval document and not a performance study report.
Therefore, I cannot fulfill your request for detailed information on acceptance criteria and study particulars based on the provided text.
§ 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.