| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
034
|
Date of Entry 01/30/2014
|
|
FR Recognition Number
|
4-188
|
| Standard | |
ISO 9917-2 Second edition 2010-04-15
Dentistry - Water-based cements - Part 2: Resin-modified cements |
|
Scope/Abstract| ISO 9917-2:2010 specifies requirements and test methods for dental cements that are intended for luting, base or lining and restoration purposes and for which the materials are water-based and set by multiple reactions in which setting is achieved by a combination of an acid-base reaction and polymerization. |
|
| Extent of Recognition
|
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| FDA recognition of ISO 9917-2 Second edition 2010-04 [Rec# 4-188] will be superseded by recognition of ISO 9917-2 Third edition 2017-09 [Rec# 4-311]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 4-188] until December 21, 2025. After this transition period, declarations of conformity to [Rec# 4-188] will not be accepted. |
|
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 Contacts
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
