NOBILCAM IMPAK Disc

The NOBILCAM IMPAK Disc is a heat-cured, moldable acrylic compound disc designed for use in CAD/CAM machines to fabricate dental appliances and prostheses, including TMJ splint appliances, nightguards, and bruxism appliances. It is supplied as a pre-formed disc in various specifications and shades to meet different clinical needs.

The subject device is an acrylic compound in disc form, prescription-use, non-sterile, packaged in a box, with storage requirements in a cool, dry area away from ignition sources. It is substantially equivalent to the predicate Clearsplint Disc (K111828), which shares identical main composition (acrylic compound), physical form (disc), indications for use, prescription status, sterility classification, and packaging. Both devices have substantially equivalent physical properties.

ISO 20795-2:2013, ADA ANSI Standard No. 99-2001 (R2023), ADA ANSI Standard No. 139-2020, ISO 7405, and ISO 10993 standards. Testing included physical properties (appearance, dimension, color stability, water sorption, water solubility, tear strength, hardness, flexural strength, and flexural modulus) and biocompatibility endpoints (cytotoxicity, irritation, sensitization, genotoxicity, acute systemic toxicity, and subchronic toxicity).

The subject device demonstrates substantial equivalence through identical indications for use with the predicate device (TMJ splints, nightguards, bruxism appliances), identical technological characteristics (acrylic compound composition, disc form, prescription classification), and comparative bench testing showing substantially equivalent physical and performance properties. The device contains only conventional chemicals consistent with legally marketed predicate and reference devices, and biocompatibility testing following ISO standards supports safety equivalence.