iCEM Universal Plus

iCEM Universal Plus is a dual-cure resin cement for dental adhesion supplied in two pastes (Catalyst and Base) that are mixed and dispensed through a dedicated mixing tip. It bonds indirect restorations (composite, ceramic, metal) and prosthetic devices (crowns, inlays, onlays, bridges, veneers) to tooth structure or implant abutments. The cement cures through both chemical and light polymerization and can be used with or without a separate primer.

iCEM Universal Plus allows surface treatment of both tooth and prosthesis with a single primer, differing from the predicate G-CEM ONE in operating procedures and product configuration. Both devices have identical indications for use with only minor differences in wording regarding veneers. The technical differences arise from variations in application methods and curing times but do not affect performance or safety, as both devices maintain the same fundamental bonding functions.

Bond strength testing per FDA guidance on Dental Cements Performance Criteria (September 30, 2024); flexural strength, film thickness, working time, setting time, x-ray opacity, water absorption, and solubility per ISO 4049:2019; compressive strength per ISO 9917-1; and biocompatibility assessment per ISO 10993-1:2018.

iCEM Universal Plus is substantially equivalent to G-CEM ONE (K200798) because both devices share identical indications for use (with only minor verbiage differences), comparable technological characteristics, and equivalent performance testing results demonstrating safety and effectiveness per FDA guidance and ISO standards. The technical differences in operating procedures and product configuration do not affect the fundamental function of dental bonding and do not raise new safety questions.