| ISO 29022 First edition 2013-06-01 Dentistry - Adhesive - Notched-edge sheer bond strength test |
| Recognition Date | 2015-01-27 |
| Recognition List | 038 |
| Recognition Number | 4-219 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Dental/ENT |
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This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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.
| 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 |
| There is no relevant guidance developed at this time. |