| ISO /TS 11405 Third edition 2015-02-01 Dentistry - Testing of adhesion to tooth structure |
| Recognition Date | 2017-08-21 |
| Recognition List | 047 |
| Recognition Number | 4-231 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Dental/ENT |
| FDA Tech | Michael Adjodha FDA/OMPT/CDRH/ODE/DAGID/DEDB 301-796-6276 michael.adjodha@fda.hhs.gov |
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 Technical Specification gives guidance on substrate selection, storage, and handling as well as essential characteristics of different test methods for quality testing of the adhesive bond between restorative dental materials and tooth structure, i.e. enamel and dentine. It includes a tensile bond strength measurement test, a test for measurement of marginal gaps around fillings, a microleakage test, and gives guidance on clinical usage tests for such materials. Some specific test methods for bond strength measurements are given for information in Annex A.
This Technical Specification does not include requirements for adhesive materials and their performance.
| Regulation Number | Device Name | Device Class | Product Code |
| §872.3750 | Adhesive, Bracket And Tooth Conditioner, Resin | Class 2 | DYH |
| §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. |