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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 4-198
Standard
ISO  3107 Fourth edition 2011-03-01
Dentistry - Zinc oxide/eugenol and zinc oxide/non-eugenol cements
Identical Adoption
ANSI ADA Standard No. 30-2013 (R2018)
Dental Zinc Oxide-Eugenol and Zinc Oxide
Scope/Abstract
This International Standard specifies requirements for non-water-based zinc oxide/eugenol cements suitable for use in restorative dentistry for temporary cementation, for bases and as temporary restorations.

This International Standard also specifies requirements for non-eugenol cements containing zinc oxide and aromatic oils suitable for temporary cementation.
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.
Transition Period
FDA recognition of ISO 3107 Fourth edition 2011-03 [Rec# 4-198] will be superseded by recognition of ISO 3107 Fifth edition 2022-09 [Rec# 4-299]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 4-198] until July 6, 2025. After this transition period, declarations of conformity to [Rec# 4-198] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§872.3275 Zinc Oxide Eugenol Class 1 EMB
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff - Dental Cements - Premarket Notification Document, issued August 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
 Bobak Shirmohammadi
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-3639
  Bobak.Shirmohammadi@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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