| Part B: Supplementary Information Sheet (SIS) |
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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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8-405
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| Standard | |
ISO 5832-4 Third edition 2014-09-15
Implants for surgery -- Metallic materials -- Part 4: Cobalt-chromium-molybdenum casting alloy |
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Scope/AbstractThis part of ISO 5832 specifies the characteristics of, and corresponding test methods for, cobalt-chromium-molybdenum casting alloy 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 the specifications given 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 |
| §872.3645 |
Implant, Subperiosteal
|
Class 2
|
ELE
|
| §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 |
Plate, Bone
|
Class 2
|
JEY
|
| §872.4760 |
Implant, Transmandibular
|
Class 2
|
MDL
|
| §872.4760 |
External Mandibular Fixator And/Or Distractor
|
Class 2
|
MQN
|
| §872.4880 |
Screw, Fixation, Intraosseous
|
Class 2
|
DZL
|
| 21 CFR 888.3XXX Metallic components of all implantables |
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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. |
