(191 days)
Dentium abutments are intended for use on endosseous dental implants in the edentulous or partially edentulous maxilla or mandible, as an aid in prosthetic rehabilitation.
All digitally designed abutments for use with Dentium CAD/CAM Abutments are intended to be sent to a Dentium-validated milling center for manufacture.
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This document is a 510(k) premarket notification acceptance letter from the FDA to Dentium Co., Ltd. for their Dentium NR Line CAD/CAM Abutments. It is not a study report or clinical trial report.
Therefore, the document does not contain any information about:
- Acceptance criteria and reported device performance (in the context of clinical or performance studies)
- Sample sizes used for test and training sets
- Data provenance (country of origin, retrospective/prospective)
- Number of experts or their qualifications for ground truth establishment
- Adjudication methods
- Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes
- Standalone algorithm performance
- Types of ground truth used
- How ground truth was established for training sets
The letter merely states that the FDA has reviewed the 510(k) submission and determined the device to be "substantially equivalent" to legally marketed predicate devices, allowing Dentium to market the device subject to general controls. It refers to the device's "Indications for Use" (which are provided on the last page) but does not detail any studies conducted to prove the device meets performance criteria.
To answer your request, a different type of document, such as a clinical study report or a 510(k) summary (which often briefly describes performance data), would be needed. This document is purely an acceptance letter based on regulatory review, not a scientific study report.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)