| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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052
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Date of Entry 07/15/2019
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FR Recognition Number
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4-259
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| Standard | |
ISO 14801 Third edition 2016-11-01
Dentistry - Implants - Dynamic loading test for endosseous dental implants |
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Identical AdoptionANSI ADA Standard No. 127-2018
Dynamic Loading Test for Endosseous Dental Implants |
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Scope/AbstractThis International Standard specifies a method of dynamic testing of single post endosseous dental implants of the transmucosal type in combination with their premanufactured prosthetic components. It is most useful for comparing endosseous dental implants of different designs or s. This International Standard is not a test of the fundamental fatigue properties of the materials from which
the endosseous implants and prosthetic components are made.
This International Standard is not applicable to dental implants with endosseous lengths shorter than 8 mm nor to magnetic attachments.
While this International Standard simulates the functional loading of an endosseous dental implant under "worst case" conditions, it is not applicable for predicting the in vivo performance of an endosseous dental implant or dental prosthesis, particularly if multiple endosseous dental implants are used for a dental prosthesis.
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Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
Note 3 of definition 3.1 - Endosseous dental implant system
Annex B - Guide to determination of worst-case conditions
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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.
This standard is recognized in part because:
Annex B is in conflict with an existing published final guidance, see Section 8 of the guidance listed below.
Note 3 of definition 3.1, endosseous dental implant system, is included in the product code NHA (endosseous dental implant abutment). |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §872.3630 |
Abutment, Implant, Dental, Endosseous
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Class 2
|
NHA
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| §872.3640 |
Implant, Endosseous, Root-Form
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Class 2
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DZE
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| §872.3640 |
Blade-Form Endosseous Dental Implant
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Class 2
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NRQ
|
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Relevant FDA Guidance and/or Supportive Publications*
Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments - Guidance for Industry and FDA Staff, Issued May 2004.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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| FDA Technical Contacts
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
