Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A,Modeling Fluid )

Porcelain Powder is a dental material used to create facings and veneers for customized denture crowns in adults over 18 years old. The product includes multiple components: Enamel/Modifier (powder form), Stain/Glaze and Stain/Glaze-A (paste forms), and Modeling Fluid (liquid form). It is a glass ceramic material composed of silica, alumina, and various oxides that is applied by trained dental professionals.

The subject device differs from the predicate by including a separate Stain/Glaze-A component (which lacks sodium fluoride found in Stain/Glaze) and offering multiple form factors (powder, liquid, and paste). Both devices use similar glass ceramic compositions with comparable physical and mechanical properties per ISO 6872, including uniformity, mixing/condensation performance, flexural strength, and thermal expansion coefficient. Both are non-sterile, surface-contacting devices for oral cavity use with long-term contact duration exceeding 30 days.

ISO 6872:2015/AMD 1:2018 (Dentistry—Ceramic Materials) for physical and mechanical properties; ISO 10993-1:2018 and ISO 7405:2018 for biocompatibility evaluation; ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization), ISO 10993-23 (oral mucosa irritation), ISO 10993-11 (acute/subchronic systemic toxicity and pyrogen), and ISO 10993-3 (bacterial reverse mutation and TK gene mutation tests).

Both devices serve as veneering materials for dental prosthetic restorations with identical indications for use in crowns (the subject device focuses on denture crowns while the predicate covers crowns and bridges, making the subject a functional subset). The main ingredients are essentially the same glass ceramic compositions, and the subject device passed all biocompatibility tests with no new safety concerns. Differences in wording between indications and product form do not reflect functional differences that would introduce new safety or effectiveness questions.