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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 038 Date of Recognition 01/27/2015 
FR Recognition Number 4-219
Standard
ISO 29022 First edition 2013-06-01
Dentistry - Adhesive - Notched-edge sheer bond strength test
Scope/Abstract
This 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.
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
§872.3750 Adhesive, Bracket And Tooth Conditioner, Resin Class 2 DYH
§872.3690 Material, Tooth Shade, Resin Class 2 EBF
§872.3275 Cement, Dental Class 2 EMA
§872.3275 Zinc Oxide Eugenol Class 1 EMB
§872.3200 Agent, Tooth Bonding, Resin Class 2 KLE
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
FDA Technical Contacts
 Michael Adjodha
  FDA/OMPT/CDRH/ODE/DAGID/DEDB
  301-796-6276
  michael.adjodha@fda.hhs.gov
 Sheena Green
  FDA/OMPT/CDRH/OC/DBM/BCB II/
  301-796-6279
  sheena.green@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Dental/ENT
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