(105 days)
The Merz Dental GmbH M-PM-Disc (Clear) is indicated for the fabrication of removable bite splints such as mouthguard and nightguards.
The Merz Dental MP-M-Disc (Clear) is a solid disc composed of a highly cross-linked homogenous combination of polymethylmethacrylate (PMMA) copolymers known as an Interpenetrated Polymer Network (IPN). This is the same material used in Merz Dental artegral Denture Teeth (K030588) and the Merz Dental M-PM-Disc (Tooth Colored) (K071548). The difference is that the MPM-Disc (Clear) PMMA does not have added pigments. The M-PM-Disc (Clear) PMMA contains polymethylmethacrylate cross-linked polymer based on methacrylic acid esters, residual peroxide and residual monomer up to a maximum of 1%. It is offered in sizes from 90 x15 mm to 114.8 x 25 mm. Bite splints are prepared from the disc using a milling technique.
The provided document describes a 510(k) premarket notification for a dental device, the Merz Dental GmbH M-PM-Disc (Clear). This submission focuses on establishing substantial equivalence to previously marketed devices based on non-clinical testing and shared material properties, rather than an AI/ML-based device. Therefore, many of the requested categories related to AI/ML device studies (such as sample sizes for test sets, expert ground truth, MRMC studies, standalone performance, training sets, etc.) are not applicable in this context.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (ISO Standard) | Performance Standard | Reported Device Performance (M-PM-Disc (Clear)) |
|---|---|---|
| Flexural Strength | >65 MPa | Meets applicable ISO Standard (>65 MPa) |
| Flexural Modulus | >2000 MPa | Meets applicable ISO Standard (>2000 MPa) |
| Water Absorption |
N/A