I.flex by Tcs
by Thermoplastic Comfort Systems, Inc.
510(k) K123396
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK123396 | Date10 Jan 2013 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
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, 20 Sep 2026
The iFlex by TCS is a removable flexible partial denture base (Product Code: EBI) manufactured from a polyolefin thermoplastic polymer. Designed for dental applications, it provides a lightweight, durable framework for partial dentures, offering improved comfort and retention compared to traditional rigid acrylic bases. Its flexible properties enhance adaptability to the oral cavity, reducing patient discomfort and improving functional performance. The material is formulated to minimize water absorption, ensuring dimensional stability and longevity.
Supplied in bulk shade forms (e.g., Natural 1) and packaged in 1-kilogram units, iFlex by TCS is intended for laboratory fabrication of removable flexible partials. The device is sterilized by the manufacturer and supplied as a non-sterile, reusable material for dental technicians to process into custom appliances. It complies with FDA 510(k) clearance (K123396) under the Dental advisory committee (DE) and meets MDR requirements. No MRI safety classification is specified, and storage should follow standard dental laboratory protocols for thermoplastic polymers.
Other devices from Thermoplastic Comfort Systems, Inc.
Questions
AI-generated answers, 20 Sep 2026
What is the iFlex by TCS primarily used for in dental applications, and how does its flexible design benefit patients?
The iFlex by TCS is designed for laboratory fabrication of removable flexible partial denture bases, replacing traditional rigid acrylic frameworks. Its flexible polyolefin thermoplastic polymer allows better adaptability to the oral cavity, reducing pressure points and improving patient comfort. The material’s lightweight and flexible properties also enhance retention, making it easier for patients to wear without discomfort.
Is the iFlex material single-use or reusable, and how should it be handled before processing into a denture?
The iFlex material is non-sterile but reusable—it is supplied in bulk for dental technicians to process into custom appliances. Since it is manufacturer-sterilized, it can be used multiple times in laboratory settings, provided standard dental laboratory protocols for thermoplastic polymers are followed. Always check for contamination or degradation before reuse.
What are the available shade options and packaging details for the iFlex material, and how is it distributed?
The iFlex is supplied in bulk shade forms, with at least one example shade listed as *Natural 1*. It comes in 1-kilogram units, packaged for dental laboratories to fabricate partial dentures. The material is distributed directly from Thermoplastic Comfort Systems, Inc., ensuring consistency in material properties for custom appliance creation.
How should the iFlex material be stored, and are there any special considerations for maintaining its integrity?
Storage should follow standard dental laboratory protocols for thermoplastic polymers, as no specific MRI safety classification or unique storage instructions are provided. Keep the material in a clean, dry environment away from direct sunlight or extreme temperatures to prevent degradation. Since it is non-sterile post-manufacturer sterilization, ensure it remains free of contamination before use.