| ISO 22112 First edition 2005-11-01 Dentistry -- Artificial teeth for dental prostheses |
| Recognition Date | 2014-01-30 |
| Recognition List | 034 |
| Recognition Number | 4-151 |
| 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.
ISO 22112:2005 specifies the classification, requirements, and test methods for synthetic polymer and ceramic teeth that are manufactured for use in prostheses used in dentistry.
| Regulation Number | Device Name | Device Class | Product Code |
| §872.3590 | Additively Manufactured, Preformed, Resin Denture Tooth | Class 2 | PZY |
| §872.3590 | Denture, Plastic, Teeth | Class 2 | ELM |
| There is no relevant guidance published at this time. |