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510(k)

Are you a manufacturer of dental devices? Is your dental lab current with the latest 510(k) news? A 510(k) is the section of Food Drug and Cosmetic Act that requires manufacturers to notify FDA of their intent to market a device. Class I, II or III medical devices that do not require Premarket Approval can be placed on the market, but it must be cleared by the FDA.

Manufacturers or dental laboratories intending to manufacture dental products may only use materials and devices that are compliant with FDA regulations and must verify existence of 510(k). Devices that require this clearance:


  • Porcelain
  • Ingots
  • Zirconia
  • Acrylic
  • Denture teeth
  • Sleep apnea appliances
  • Implant abutments (both stock and custom)
  • Other Class II devices

You may be exempt from needing a 510(k) if your dental lab does not plan to manufacture these devices in-house. Having an up-to-date 510(k) intact is only required for manufacturers that produce dental devices.

At SafeLink Consulting, we will assist you to determine if your business model meets this requirement. If not, our consulting services go above and beyond just the 510(k) submission process. We have been serving the dental industry for over 20 years and we will consult with your business and your team members throughout each compliance order.

To learn more about our guidance process or to see how SafeLink Consulting can improve your dental organization’s quality system, contact us or call 800-330-6003.

Contact Us
  • Address: 327 Dahlonega Street, Suite 601A
    Cumming, GA 30040 USA
  • Phone: (770) 205-6745
  • Email: support@safelinkconsulting.com
  • Monday - Friday: 9:00 am - 5:00 pm
    Saturday - Sunday: Closed
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