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In May 2004, FDA issued a guidance document that reclassified certain dental implants from Class III to Class II, thereby reducing regulatory burdens while maintaining safety standards. What type of dental implants were reclassified?

Root-form endosseous dental implants and their abutments. These implants are designed to mimic the shape and function of a natural tooth root. They are surgically placed within the jawbone and serve as a foundation for a prosthetic tooth or teeth. The most common type of root-form endosseous implant is a titanium post. Source: www.fda.gov 

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Topics:
FDA Compliance/Regulatory Affairs FDA Requirements and Review Implants & Prosthetics Medical Product Development Regulatory and Guidance Documents

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