| ISO 21563 First edition 2013-08-15 Dentistry - Hydrocolloid impression materials |
| Recognition Number | Dental/ENT |
| Recognition Date | 2018-06-07 |
| Recognition List | 049 |
| Recognition Number | 4-240 |
| 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 International Standard specifies the requirements and tests for helping determine whether the elastic aqueous agar and alginate hydrocolloid dental impression materials, as prepared for retail marketing, are of the quality needed for their intended purposes. It also specifies requirements for labelling and instructions for use.
NOTE This International Standard specifies no requirements or tests for freedom from unacceptable biological hazards. However, it is recommended that, to address possible biological hazards associated with the use of hydrocolloid impression materials, interested parties should refer to ISO 7405 and ISO 10993.
| Regulation Number | Device Name | Device Class | Product Code |
| §872.3760 | Resin, Denture, Relining, Repairing, Rebasing | Class 2 | EBI |
| §872.3660 | Material, Impression | Class 2 | ELW |
| Guidance for Industry and FDA Staff: Dental Impression Materials - Premarket Notification, Issued August 1998. |