(165 days)
DENTALOS PLUS discs are milling blanks consisting of Polymethylmethacrylate (PMMA) and designed for the fabrication of long-term temporary crown and bridgework. They are machined by use of the CAD/CAM technique.
DENTALOS PLUS discs are recommended for manufacturing substructures of single tooth crowns and bridgeworks with up to two pontics.
DENTALOS PLUS discs are milling blanks composed of hot cured polymethylmethacrylate (PMMA). They are intended to be used by dental professionals e.g. dental technicians for the fabrication of long-term temporary crowns and bridgeworks as custom-made restorations for the sole use of a particular patient. These restorations are designed virtually by dental technicians using the CAD technology on the basis of intraoral scans or scans from impressions and/or models. The designed restorations can thereafter be machined in all appropriate CAM Milling Centers out of DENTALOS PLUS Discs. In a further step the milled workpiece can be individually characterized with veneering materials and polished for to improve the aesthetic appearance of the finished restoration. DENTALOS PLUS discs are offered as monochrome discs (DENTALOS PLUS MONO) in nine different shades and as multicolored discs (DENTALOS PLUS MULTICOLOR) in five shades, all discs in different thicknesses.
The document provided is a 510(k) Summary for a medical device called "DENTALOS PLUS MONO" and "DENTALOS PLUS MULTICOLOR," which are milling blanks made of polymethylmethacrylate (PMMA) for fabricating temporary crowns and bridges. This submission is for establishing substantial equivalence to a predicate device, not for a novel AI/software device.
Therefore, the requested information about acceptance criteria and study details related to AI/software performance (e.g., sample sizes for training/test sets, expert adjudication, MRMC studies, standalone performance, ground truth establishment) is not applicable to this document.
The document focuses on demonstrating physical and material property comparability of the new device to a predicate device (BRIGHTGLASS and BRIGHTGLASS M).
However, I can extract the relevant information from the document regarding the performance testing that was conducted:
1. A table of acceptance criteria and the reported device performance
The document reports performance parameters for the "DENTALOS PLUS MONO" and "DENTALOS PLUS MULTICOLOR" devices, and implicitly expects them to be comparable to the predicate devices. The table below presents the reported physical properties. The acceptance criteria are implied to be "comparable to the predicate devices," as stated in the "Performance Testing" section.
| Performance Parameter | Reported Device Performance (DENTALOS PLUS MONO/MULTICOLOR) | Acceptance Criteria (Implicit: Comparable to Predicate) |
|---|---|---|
| e-module | 3370 MPA | 3370 MPA (Predicate: BRIGHTGLASS/BRIGHTGLASS M) |
| Tensile Strength | 76.3 MPA | 76.3 MPA (Predicate: BRIGHTGLASS/BRIGHTGLASS M) |
| Elastic Limit | 70 MPA | 70 MPA (Predicate: BRIGHTGLASS/BRIGHTGLASS M) |
| Bending Strength | 106 MPA | 106 MPA (Predicate: BRIGHTGLASS/BRIGHTGLASS M) |
| Water Absorption | 19.36 µg/m³ | 19.36 µg/m³ (Predicate: BRIGHTGLASS/BRIGHTGLASS M) |
| Water Solubility |
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.