Permaflex Permanent Soft Denture Reliner
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K925062 FDA 510(k)
- FDA Product Code
- EBI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3760 FDA 510(k)
- Regulation Number
- 872.3760 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Permaflex Permanent Soft Denture Reliner is a dental device classified as a soft denture reliner (product code EBI). It is designed to provide a permanent, soft lining for existing dentures, improving comfort and fit by conforming to the wearer’s oral tissues. This reliner is intended to replace the inner surface of a denture without requiring laboratory processing, offering a durable and flexible alternative to traditional relining materials. Its formulation ensures long-term wearability while maintaining structural integrity.
This device is supplied as a single-use kit and requires no sterilization, as it is intended for one-time application per denture. It is non-magnetic and safe for use in non-regulated settings, such as dental offices or home use under professional guidance. The reliner is packaged for immediate clinical use and adheres securely to the denture base without adhesives. Authorized under FDA 510(k) clearance (K925062), it complies with dental product regulations for permanent relining applications.
Frequently asked questions
What is the Permaflex Permanent Soft Denture Reliner used for?
The Permaflex Permanent Soft Denture Reliner is designed to replace the inner surface of an existing denture, providing a permanent soft lining. It improves comfort and fit by conforming to the wearer’s oral tissues, eliminating gaps and reducing irritation. Unlike traditional relining materials, this kit allows for immediate application without requiring laboratory processing, making it ideal for dentists or patients seeking a convenient, durable solution.
How is the Permaflex Permanent Soft Denture Reliner supplied, and is it reusable?
The Permaflex Permanent Soft Denture Reliner is supplied as a single-use kit, meaning each kit is intended for one application per denture. It does not require sterilization, as it is non-sterile and designed for one-time use. This ensures hygiene and eliminates the need for reprocessing, making it suitable for both clinical and home use under professional guidance.
Does this reliner require adhesives to secure it to the denture?
No, the Permaflex Permanent Soft Denture Reliner adheres securely to the denture base without the need for additional adhesives. Its formulation is engineered to bond directly to the denture material, providing a stable and long-lasting fit. This feature simplifies the application process and reduces potential issues with adhesive residue or irritation.
Is the Permaflex Permanent Soft Denture Reliner safe for use in non-regulated settings?
Yes, the Permaflex Permanent Soft Denture Reliner is designed for safe use in non-regulated settings such as dental offices or at home, provided it is applied under professional guidance. It is non-magnetic and intended for direct clinical use, ensuring compatibility with standard dental practices without requiring specialized equipment or environments.
What regulatory clearance does the Permaflex Permanent Soft Denture Reliner hold?
The Permaflex Permanent Soft Denture Reliner holds FDA 510(k) clearance under the classification of a soft denture reliner (product code EBI). This clearance indicates that the device has been deemed substantially equivalent to a legally marketed predicate device, meeting regulatory standards for safety and effectiveness in permanent denture relining applications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PERMAFLEX PERMANENT SOFT DENTURE RELINER (K925062) — FDA 510 (k ..., ProTech Professional Products, Inc., Permaliner Full Kit — ProTech Professional Products, Inc., Protech Professional… — 2 FDA 510 (k)s · DeviceClearance
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K925062 | Class II | Active |
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Manufacturer
- Manufacturer
- Protech Professional Products, Inc.
Sources (1)
- FDA 510(k) K925062 24 fields · synced Oct 1, 2026