| ISO 14801 Second edition 2007-11-15 Dentistry-Implants-Dynamic fatigue test for endosseous dental implants |
| Recognition Date | 2014-01-30 |
| Recognition List | 034 |
| Recognition Number | 4-195 |
| 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 |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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.
| 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 |
| 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 |