VITA VMLC Primer

VITA VM LC Primer is a two-component dental bonding system (Primer I and Primer II) used to promote adhesion between dental prosthetic substructures and light-curing (meth)acrylate-based composite veneering resins. It bonds metal alloys, titanium, zirconia, and high-performance polymers like PEEK to methacrylate-based composite resins used in dental prosthetics.

The subject device uses a two-component sequential application approach with a light-curable component, whereas predicate devices may differ in their application method. Both use functional monomer-based chemical coupling to promote bonding between prosthetic substrates and methacrylate resin materials. These differences do not alter the intended use or raise new safety or effectiveness questions.

Non-clinical bench testing was performed in accordance with ISO 10477 (including thermal cycling). Biocompatibility was evaluated per FDA's Guidance on ISO 10993-1 (Biological evaluation of medical devices) and ISO 7405 (Dentistry—Evaluation of biocompatibility of medical devices used in dentistry).

VITA VM LC Primer is substantially equivalent because it uses the same functional monomer-based chemical coupling mechanism as predicate devices to bond prosthetic substrates to methacrylate resins, demonstrated adequate bond strength across indicated substrates via ISO 10477 testing, and showed acceptable biocompatibility. The two-component sequential application design does not raise new or different safety or effectiveness concerns compared to predicates.