Our Experience in Dental Devices

Our mission is to provide best-in-class regulatory, clinical, and reimbursement services to help our clients achieve their product development and commercialization goals. We have structured our approach to navigating the regulatory and commercial landscape to align with the FDA's focus on the Total Product Life Cycle, a regulatory framework that integrates all aspects of product development. The battery of services in MCRA Dental portfolio therefore enables us to partner with our clients through the various stages of the innovation process, from conception, through pre-market development and FDA approval, to widespread market use and payor reimbursement. As stewards of technologies intended to maintain dental health and treat dental problems, MCRA’s social responsibility is woven into the fabric of what we do and fuels our passion to bring the most advanced dental therapies to those in need.

MCRA Dental has decades of combined experience and direct oversight from multiple former FDA personnel from the dental field, and are capable of taking on projects of any complexity, including (but not limited to) those within the following product areas:

  • Additive Manufactured Dental devices (e.g., customized Implants, Crowns, Plates, Dentures, Restorations etc.)

  • Bone Grafts

  • Bone Substitutes

  • Dental Abutments

  • Dental Amalgams

  • Dental Cements

  • Dental Combination Products

  • Dental Imaging Equipment

  • Dental Implants

  • Dental Membranes

  • Dental Plates

  • Intraosseous Fixations

  • Lasers

  • Mandibular Condyle Prostheses

  • Maxillofacial Reconstruction Implants

  • Orthodontic Appliances

  • OTC Denture Cushions

  • Total Temporomandibular Joint Prostheses

  • Transmandibular Implants