| ISO 10139-2 Second edition 2009-08-01 Dentistry - Soft lining materials for removable dentures - Part 2: Materials for long-term use |
| Recognition Date | 2014-01-30 |
| Recognition List | 034 |
| Recognition Number | 4-182 |
| 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 part of ISO 10139 specifies requirements for softness, adhesion, water sorption and water solubility as well as for packaging, marking and manufacturer's instructions for soft denture lining materials suitable for long-term use. These materials may also be used for maxillofacial prostheses.
| Regulation Number | Device Name | Device Class | Product Code |
| §872.3760 | Resin, Denture, Relining, Repairing, Rebasing | Class 2 | EBI |
| Guidance for Industry and FDA Staff OTC Denture Cushions, Pads, Reliners, Repair Kits, and Partially Fabricated Denture Kits Document issued on: August 18, 1998 |