Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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060
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Date of Entry 05/29/2023
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FR Recognition Number
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4-307
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Standard | |
ISO 13504 First edition 2012-07 Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment |
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Scope/AbstractISO 13504:2012 specifies general requirements for the manufacture of instruments and related accessories used in the placement of dental implants and further manipulations of connecting parts in the craniofacial area.
It is applicable to single-use and reusable instruments, regardless of whether they are manually driven or connected to a power-driven system. |
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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 |
§872.3980 |
Accessories, Implant, Dental, Endosseous
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Class 1
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NDP
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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. |