Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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041
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Date of Entry 04/04/2016
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FR Recognition Number
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8-406
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Standard | |
ISO 5832-11 Second edition 2014-09-15 Implants for surgery -- Metallic materials -- Part 11: Wrought titanium 6-aluminium 7-niobium alloy |
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Scope/AbstractThis part of ISO 5832 specifies the characteristics of, and corresponding test methods for, the wrought titanium alloy known as titanium 6-aluminium 7-niobium alloy (Ti-6-Al 7-Nb) for use in the manufacture of surgical implants.
NOTE The mechanical properties of a sample obtained from a finished product made of this alloy might not necessarily comply with those specified in this part of ISO 5832.
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Extent of Recognition
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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. |
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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 |
§872.3645 |
Implant, Subperiosteal |
Class 2 |
ELE |
§872.3890 |
Splint, Endodontic Stabilizing |
Class 2 |
ELS |
§872.3940 |
Joint, Temporomandibular, Implant |
Class 3 |
LZD |
§872.3950 |
Glenoid Fossa Prosthesis |
Class 3 |
MPI |
§872.3960 |
Mandibular Condyle Prosthesis |
Class 3 |
MPL |
§872.4600 |
Lock, Wire, And Ligature, Intraoral |
Class 2 |
DYX |
§872.4760 |
External Mandibular Fixator And/Or Distractor |
Class 2 |
MQN |
§872.4760 |
Implant, Transmandibular |
Class 2 |
MDL |
§872.4760 |
Plate, Bone |
Class 2 |
JEY |
§872.4880 |
Screw, Fixation, Intraosseous |
Class 2 |
DZL |
21 CFR 888.3XXX Metallic components of all implantables |
21 CFR 872.4XXX Metallic components |
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Relevant FDA Guidance and/or Supportive Publications*
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. |