Silkline Soft Relining Kit Model 28-100100
510(k) K060844
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK060844 | Date6 Jun 2006 | StatusActive |
Official records
- FDA 510(k) database K060844
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EBI
- FDA applicant
- J. Morita USA, Inc.
- 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
The Silkline Soft Relining Kit Model 28-100100 is a dental relining material designed for repairing or rebasing denture bases. Classified under product code EBI, it is a silicone-based resin intended to improve the fit, comfort, and structural integrity of dentures. This material is specifically formulated to address common issues such as poor adaptation or wear in denture bases, ensuring a more stable and patient-friendly restoration. Its composition aligns with dental restorative materials used in clinical settings for denture adjustments.
This kit is supplied for professional use by dentists in a clinical environment and has received FDA 510(k) clearance under the Traditional pathway, classified as Substantially Equivalent to a predicate device. The material is non-odoriferous and tasteless, with properties including strong adhesion, durability, and resistance to tear, abrasion, and discoloration. While not explicitly stated as single-use or reusable, its application is typically performed in a sterile or controlled setting to maintain patient safety. No additional regulatory markings beyond the FDA clearance are referenced in the specifications.
Devices cleared under K060844
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Silk Line Kit 28100100 | 28100100 | 10852253006134 | — | On the market |
| Silk Line Primer 28100300 | 28100300 | 10852253006158 | — | On the market |
| Silk Line Refill Cartridge 28100200 | 28100200 | 10852253006141 | — | On the market |
| Silk Line Varnish Base | Silk Line Varnish Base | 10852253006165 | — | No longer on the market |
| Silk Line Varnish Catalyst | Silk Line Varnish Catalyst | 10852253006172 | — | No longer on the market |