Dental Laboratory FDA 510(k) Consultants
Are you a manufacturer of dental devices? A 510(k) is the section of the Food, Drug and Cosmetic Act that requires product developers to notify the FDA of their intent to market a device. SafeLink helps you determine whether your business model requires clearance.
Manufacturers or dental laboratories intending to manufacture dental devices may only use materials and components compliant with FDA regulations, and must verify the existence of a 510(k) for patient-contact materials that require clearance. Examples of devices that require this clearance include:
You may be exempt from needing an FDA 510(k) if your dental lab does not manufacture these devices in-house — for example, in-house milled custom implant abutments. SafeLink will help you determine whether your business model meets this requirement. We have served the dental lab industry for over 20 years. To learn more or see how we can improve your dental lab quality system, contact us or call 800-330-6003.
Ready to Protect Your Practice or Organization?
Our compliance advisors are ready to help you stay ahead of inspections, regulatory changes, and the evolving risk landscape. Whether you need a one-time assessment or a long-term advisory partner, SafeLink will build a solution that fits your industry, your team, and your budget.
Serving businesses nationwide since 1991 including dental practices, dental laboratories, medical, device manufacturers, and general industry.