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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 034 Date of Entry 01/30/2014 
FR Recognition Number 4-195
Standard
ISO 14801 Second edition 2007-11-15
Dentistry - Implants-Dynamic fatigue test for endosseous dental implants
U.S. Identical Adoption
ANSI ADA Standard No. 127-2012
Fatigue Testing for Endosseous Dental Implants
Scope/Abstract
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.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
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
Relevant FDA Guidance and/or Supportive Publications*
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
FDA Technical Contact
 Andrew Steen
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6284
  Andrew.Steen@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Dental/ENT
*These are provided as examples and others may be applicable.
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