TopCEM-Try in Veneer Try-in Gel

TopCEM-Try in Veneer Try-in Gel is a dental material used to evaluate the shade and matching of restorations prior to permanent cementation. It is composed primarily of polyethylene glycol, inorganic fillers, and pigments, delivered as a hydrophilic paste in a syringe that can be rinsed off with water.

The subject device is a paste form with hydrophilic properties, similar to the primary predicate (Variolink Esthetic Try-In). Both contain polyethylene glycol or glycerin-based components with inorganic fillers and pigments. Storage conditions differ slightly (2-25°C vs. 2-28°C). Both are prescription-use materials delivered in syringes with substantially equivalent physical properties per internal inspection standards.

ISO 10993 standards were applied for biocompatibility testing, including cytotoxicity, sensitization, and irritation endpoints. The FDA guidance on 'Use of International Standard ISO 10993-1' was followed for biological evaluation of medical devices.

The subject device demonstrates substantial equivalence because it shares the same intended use (shade evaluation before permanent cementation), identical prescription-use classification, and paste delivery form as the primary predicate. Both devices use similar hydrophilic chemistry based on polyethylene glycol with inorganic fillers and pigments, with substantially equivalent physical properties confirmed by testing. The minor differences in indications wording and storage temperature do not affect the general intended use. Biocompatibility testing shows no non-conventional chemicals compared to predicate devices, establishing substantial equivalence.