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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 034 Date of Entry 01/30/2014 
FR Recognition Number 4-153
Standard
ISO  9917-1 Second edition 2007-10-01
Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements
Scope/Abstract
This 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.
Extent of Recognition
Complete standard
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.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§872.3275 Cement, Dental Class 2 EMA
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.
FDA Technical Contact
 Michael Adjodha
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6276
  michael.adjodha@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Dental/ENT
*These are provided as examples and others may be applicable.
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