Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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038
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Date of Entry 01/27/2015
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FR Recognition Number
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4-219
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Standard | |
ISO 29022 First edition 2013-06-01 Dentistry - Adhesive - Notched-edge sheer bond strength test |
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Scope/AbstractThis International Standard specifies a shear test method used to determine the adhesive bond strength between direct dental restorative materials and tooth structure, e.g. dentine or enamel. The method as described is principally intended for dental adhesives. The method includes substrate selection, storage and handling of tooth structure, as well as the procedure for testing. |
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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 |
§872.3200 |
Agent, Tooth Bonding, Resin
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Class 2
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KLE
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§872.3275 |
Cement, Dental
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Class 2
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EMA
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§872.3275 |
Zinc Oxide Eugenol
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Class 1
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EMB
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§872.3690 |
Material, Tooth Shade, Resin
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Class 2
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EBF
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§872.3750 |
Adhesive, Bracket And Tooth Conditioner, Resin
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Class 2
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DYH
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Relevant FDA Guidance and/or Supportive Publications*
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 Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |