Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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034
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Date of Entry 01/30/2014
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FR Recognition Number
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4-153
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Standard | |
ISO 9917-1 Second edition 2007-10-01 Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements |
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Scope/AbstractThis part of ISO 9917 specifies requirements and test methods for powder/liquid acid-base dental cements intended for permanent cementation, lining and restoration. This part of ISO 9917 is applicable to both hand-mixed and capsulated cements for mechanical mixing. This part of ISO 9917 specifies limits for each of the properties according to whether the cement is intended for use as a luting agent, a base or liner or as a restorative material. This part of ISO 9917 is not intended to address resin-modified water-based cements. |
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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 |
§872.3275 |
Cement, Dental
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Class 2
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EMA
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Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff Dental Cements - Premarket Notification Document issued on: August 18, 1998
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 Contact
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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. |