(49 days)
Nobel Biocare's Procera Software imports patient specific data from scanners and defines the shapes of dental prosthetic devices such as dental abutments, copings, laminates, and bridges through the use of a 3D-CAD tool. The software also serves as a means of ordering and managing orders of Procera products.
The Procera Client Management System (PCMS) software is intended to be used by dental practitioners and dental labs. Through the use of the PCMS software, a customer can import scanned data from the Procera scanners and define the shapes of Procera products through the use of a 3D-CAD tool. The user can then place and manage orders of the resulting Procera dental products.
The provided text describes a 510(k) premarket notification for the "Procera Software," a 3D-CAD tool for designing dental prosthetic devices and managing orders. However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is absent from the provided text.
Specifically, the document focuses on:
- Device Description and Indications for Use: What the software does.
- Regulatory Information: Classification, predicate devices, and FDA's substantial equivalence determination.
- Procedural Details: Submission dates, contact information, and regulatory compliance advice.
There is no mention of any performance study, clinical trial, or validation testing of the software's accuracy in defining shapes or any other functional aspect.
§ 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.)