ISO 14801 Second edition 2007-11-15

Standard Organization:

ISO 14801 Second edition 2007-11-15
Dentistry-Implants-Dynamic fatigue test for endosseous dental implants

Recognition Date2014-01-30
Recognition List034
Recognition Number4-195
Extent Complete standard
Standards Orgs ISO International Organization for Standardization https://www.iso.org/
STG Dental/ENT
FDA Tech  Andrew Steen   FDA/OMPT/CDRH/ODE/DAGID/DEDB/   301-796-6284   andrew.steen@fda.hhs.gov

Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

ISO 14801:2007 specifies a method of fatigue testing of single post endosseous dental implants of the transmucosal type and their premanufactured prosthetic components. It is most useful for comparing endosseous dental implants of different designs or s.

While it simulates the functional loading of an endosseous dental implant body and its premanufactured prosthetic components under "worst case" conditions, ISO 14801:2007 is not applicable for predicting the in vivo performance of an endosseous dental implant or prosthesis, particularly if multiple endosseous dental implants are used for a prosthesis.

Code of Federal Regulations:

Regulation Number Device Name Device Class Product Code
§872.3640 Implant, Endosseous, Root-Form Class 2 DZE
§872.3630 Abutment, Implant, Dental, Endosseous Class 2 NHA

FDA Guidance:

Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments - May 12, 2004.
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm072424.htm


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