Dental Device Expertise
Aptiv Solutions has managed over 60 regulatory and clinical trial projects for dental/maxillofacial devices and accessories, including those involving FDA and international regulatory submissions. Our dental device experience includes:
- Dental implant systems and tools – FDA regulatory strategy, 510(k) preparation, Canadian medical device license application
- Radiological 3D software for dental diagnostics – 510(k) preparation and submission
- Ultrasonic dental devices – software documentation review, performance testing program support, 510(k) preparation
- Bone regeneration studies – Full service clinical trial support
- Dental handpieces – development of reuse validation testing programs, 510(k) premarket notification preparation
- Curing lamps – software documentation review, performance testing program support, 510(k) premarket notification preparation
- Endosseous implants – clinical trial design, monitoring and data management activities to support FDA requirements
Dental Device Case Study
A European manufacturer with a broad array of dental devices including dental operative units, ultrasonic scalers, curing lamps, airbrushes, and dental handpieces, manufactures many devices that incorporate cutting-edge technological advancements. Some examples are power advancements of an ultrasonic generator, light source and power delivered by curing lamp, increased sophistication of electronic control systems to improve the ease of use of already marketed devices, and expansion of indications for use to include new dental procedures. This company has a long-standing relationship with Aptiv Solutions and has turned to us for assistance with the assembly of the appropriate software documentation and development of performance testing to support multiple 510(k) premarket notifications, for both new devices and device modifications. Aptiv Solutions worked with the client to overcome the significant challenge of developing the appropriate testing to validate the cleaning and disinfection of those devices with reusable components that directly contact the patient, i.e. dental handpieces, and devices containing waterlines.
Contact us today to learn more about our dental device expertise.
