Tuf Link Silicone Reliner
by Dentatus USA, Ltd. 510(k)
Active
510(k) K042931
Overview
The Tuf Link Silicone Reliner is a silicone polymer relining material classified under Denture Relining, Repairing (21 CFR 872.3760). It is designed to resurface the hard-acrylic base of dentures, improving patient comfort and addressing prosthodontic challenges by providing a durable, resilient soft lining. This material is intended for use in relining existing dentures to restore fit and functionality over time. Its silicone composition offers flexibility and longevity compared to traditional acrylic reliners.
The Tuf Link Silicone Reliner is supplied as a kit for dental professionals to apply in clinical settings, adhering to standard denture relining protocols. It is intended for single-use per application, though the base denture itself may be reused after relining. The device carries FDA 510(k) clearance (K042931) under the Traditional review pathway, with no specific MRI safety or sterility requirements noted in the regulatory submission. Storage follows standard dental material guidelines, and its use is governed by the Dental advisory committee classification.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK042931 | Date8 Dec 2004 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- EBI
- FDA applicant
- Dentatus USA , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3760
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Other devices from Dentatus USA Ltd.
Questions
What is the Tuf Link Silicone Reliner used for?
The Tuf Link Silicone Reliner is designed to resurface the hard-acrylic base of existing dentures, enhancing patient comfort and restoring fit and functionality over time. Its silicone polymer composition provides flexibility and longevity, addressing common prosthodontic challenges associated with traditional acrylic reliners.
How is the Tuf Link Silicone Reliner supplied and intended for use?
The Tuf Link Silicone Reliner is supplied as a clinical kit for dental professionals to apply in office settings. It follows standard denture relining protocols and is intended for single-use per application, though the underlying denture base itself may be reused after relining.
Is the Tuf Link Silicone Reliner sterile and reusable?
The Tuf Link Silicone Reliner is not described as sterile in the regulatory submission, so it should be handled under standard dental material protocols. It is intended for single-use per application, but the original denture base can be reused after relining with this material.
What regulatory pathway does the Tuf Link Silicone Reliner follow?
The Tuf Link Silicone Reliner received FDA clearance under the Traditional review pathway via a 510(k) submission (K042931). It is classified under Denture Relining, Repairing (21 CFR 872.3760) and falls under the Dental advisory committee classification.
How should the Tuf Link Silicone Reliner be stored?
Storage instructions for the Tuf Link Silicone Reliner follow standard dental material guidelines, though specific conditions (e.g., temperature, humidity) are not detailed in the regulatory data. Dental professionals should refer to the manufacturer’s accompanying instructions for optimal handling and shelf-life.