Elastic Impression Material

OK Dental is an addition-cure vinyl polysiloxane dental impression material used to capture imprints of teeth and soft tissues for crown and bridge, edentulous, orthodontic, and implant applications. The material is supplied in three viscosity forms (light/regular body wash, regular body, and heavy body) and sets to form an elastic negative mold of the dentition.

The subject device shares the same principle of operation, mode of use, and intended indications as the predicate device (K133071). Both are addition-cure vinyl polysiloxane materials composed of a matrix and catalyst with similar compositions. The main differences are product name nomenclature and shelf-life (2 years vs. 3 years); the subject device uses Type 0 consistency versus Type 3 in the predicate, but Type 0 has the largest consistency and is deemed fully representative.

ISO 10993-23:2021 (biocompatibility irritation), ISO 10993-5:2009 (in vitro cytotoxicity), ISO 10993-10:2021 (skin sensitization), and ISO 4823:2021 (device effectiveness for dental impression materials).

The device is substantially equivalent because it incorporates identical intended use and fundamental technological characteristics (same operation principle and mode of use) as the predicate device. Both have verified safety and effectiveness through FDA-recognized standards, with the subject device using an upgraded biocompatibility standard (ISO 10993-23 instead of ISO 10993-3). Differences in shelf-life and product type do not affect core functionality or safety profile, thus maintaining substantial equivalence.