Myerson's PermaSoft Soft Reline Material
510(k) K933468
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK933468 | Date5 Jan 1994 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- EBI
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3760
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
Myerson's PermaSoft Soft Reline Material is a soft denture reline material classified as a Denture Liner under the FDA’s dental product category. It is designed to provide cushioning and stability for dentures by conforming to the oral tissues, improving comfort and retention. The material is formulated to resist staining, cracking, and hardening while maintaining softness for an extended period. Its composition includes polymethylmethacrylate powder blended with a liquid containing Di-n-butyl phthalate, ethyl acetate, and ethyl alcohol.
This material is supplied as a two-component system for use in dental laboratories or chairside applications, requiring mixing before application. It can be processed using either direct or indirect techniques, with curing achieved in 10 minutes via immersion in hot water. The material is intended for single-use per application, as it is not designed for repeated sterilization or reuse. Authorized for dental use under FDA 510(k) clearance (K933468), it adheres to standard dental safety and regulatory standards without MRI restrictions.