(164 days)
Titanmagnetics are allowed to be used only in responsibility of a physician, dentist or maxillofacial surgeon for following indications: Gero-prosthetics Magnet attachment adaptable to different implants or root caps (post). Anchoring of hybrid and partial dentures in category nº III (toothless jaw) and category nº IIc (very few teeth left). The classification is according to the BDIZ-Expert Commitee 1997. For lower jaw (mandible) treatments belonging to category nº III; at least 2 to 4 implants shall be inserted, in the upper jaw (maxilla) at least 3 or 4 implants.
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I am sorry, but the provided text from the FDA 510(k) clearance letter for the STECO-TITANMAGNETICS device does not contain the specific information required to describe the acceptance criteria and the study that proves the device meets those criteria in the format you requested.
The document is a clearance letter, which means the FDA has determined the device is substantially equivalent to a predicate device already on the market. It does not typically detail the specific performance studies, acceptance criteria, sample sizes, or ground truth methods that would have been conducted by the manufacturer to support their 510(k) submission.
These details would be found in the actual 510(k) summary or the full 510(k) submission itself, which is a much more extensive document than this clearance letter.
Therefore, I cannot populate the table or answer the specific questions based on the information provided.
§ 872.3165 Precision attachment.
(a)
Identification. A precision attachment or preformed bar is a device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended for use in prosthetic dentistry in conjunction with removable partial dentures. Various forms of the device are intended to connect a lower partial denture with another lower partial denture, to connect an upper partial denture with another upper partial denture, to connect either an upper or lower partial denture to a tooth or a crown, or to connect a fixed bridge to a partial denture.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.