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FDA 510k Consultants

How do you really know where your business stands in regard to FDA compliance?

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 the Food Drug and Cosmetic Act that requires product developers to notify FDA of their intent to market a device. Changes in technology used to manufacture a device or a change in the intended use of the medical device can also require submission of a 510(k) premarket notification to FDA. Class I, II or III medical devices that do not require Premarket Approval can be placed on the market, but they must be cleared by the FDA prior to marketing and distribution.

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

Custom implant abutment
  • 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 an FDA 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. An example would be the manufacture in-house of milled custom implant abutments by a dental laboratory. There are several business models available to dental laboratories who provide custom implant abutments to their dental clients.

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

Learn more about FDA 510k for General Industry.

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

About Safelink Consulting

SafeLink presenters are nationally recognized for providing workshops and seminars to diverse audiences. Through onsite visits, seminars, and Webinars SafeLink’s presenters have successfully trained thousands of our clients’ employees on safety and quality management.

Location
  • 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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