Bringing Dental Devices to Market

Introducing a new medical technology to the market can be a complicated process. In addition to the basic concerns regarding quality control and supply chain that all manufacturers must face, dental technologies are subject to other concerns that can have a significant impact on their success. For example, there’s the complex regulatory landscape in the domestic market as well as those in the myriad territories overseas. Many dental medical device companies also may have difficulties securing reimbursement from insurance providers. In most cases, overcoming these obstacles comes down to having the proper expertise and know-how on their side. MCRA’s dental medical device consulting capabilities offer these to our clients so they can navigate their challenges and find success.

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 dental specialty services in our 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.

With the help of our dental medical device consulting, our clients have the resources they need to manage every aspect of their intraoral devices’ development cycle. 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 teeth 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

Contact a Dental Device Expert

Our Team

The experience and expertise our team brings to the table are what enable us to deliver the most successful specialty dental services. Meet our experts within this field below. 

View Contact
Mehdi Kazemzadeh-Narbat, Ph.D., PMP, CQA

Mehdi Kazemzadeh-Narbat, Ph.D., PMP, CQA

Director, Regulatory Affairs

Dental Medical Devices Services