Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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062
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Date of Entry 05/29/2024
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FR Recognition Number
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4-325
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Standard | |
ANSI ADA Standard No. 96-2020 Dental Water-based Cements |
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Scope/AbstractPart 1 of ADA Standard No. 96 specifies requirements and test methods for powder/liquid acid-base dental cements intended for permanent cementation, lining and restoration. Part 1 is applicable to both hand-mixed and capsulated cements for mechanical mixing. Part 1 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. Part 1 of this standard is not intended to address resin-modified water-based cements, which are addressed in Part 2. |
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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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Transition Period
FDA recognition of ANSI ADA Standard No. 96-2012 [Rec# 4-215] will be superseded by recognition of ANSI ADA Standard No. 96-2020 [Rec# 4-325]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 4-215] until July 05, 2026. After this transition period, declarations of conformity to [Rec# 4-215] will not be accepted. |
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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 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. |
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FDA Technical Contacts
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Standards Development Organizations
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |