Ionosit Base Liner
by Foremost Dental Mfg., Co. 510(k)
Active
510(k) K935689
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK935689 | Date21 Jan 1994 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
- EBD
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3310
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Ionosit Base Liner is a dental base material designed as a Coating, Filling Material, and Resin (per FDA classification). It functions as a stress-reducing liner beneath composite or amalgam restorations, employing controlled expansion technology to mitigate polymerization shrinkage. This helps prevent microfractures, leakage, and post-operative sensitivity, thereby supporting durable and gap-free restorations in dental procedures.
Supplied as a single-component, light-cured material, the Ionosit Base Liner is intended for use in dental settings to block undercuts in inlay/onlay restorations. It is classified as a Class II device under FDA regulations (872.3310) and holds a FDA 510(k) clearance (K935689) with a Substantially Equivalent determination. The product is non-sterile and reusable per standard dental protocols, with no noted MRI safety restrictions. Storage follows general dental material guidelines.
Other devices from Foremost Dental Mfg., Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Ionosit Base Liner used for in dental procedures?
The Ionosit Base Liner is designed as a stress-reducing dental material used beneath composite or amalgam restorations. It employs controlled expansion technology to counteract polymerization shrinkage, which helps prevent microfractures, leakage, and post-operative sensitivity. This ensures durable, gap-free restorations, particularly in inlay/onlay procedures where blocking undercuts is critical.
How is the Ionosit Base Liner supplied and what type of curing does it require?
The Ionosit Base Liner is supplied as a single-component material that requires light-curing to activate. This means it must be exposed to a dental curing light to harden properly during application. The light-curing process is essential for achieving its stress-reducing properties beneath restorations.
Is the Ionosit Base Liner sterile or reusable, and how should it be stored?
The Ionosit Base Liner is classified as non-sterile and is intended for reuse following standard dental protocols. Storage should adhere to general dental material guidelines, which typically involve keeping it in a clean, dry environment away from direct sunlight or extreme temperatures to maintain its integrity and performance.
Does the Ionosit Base Liner have any restrictions for use in MRI environments?
There are no noted MRI safety restrictions for the Ionosit Base Liner. However, as with all dental materials, it is always advisable to verify compatibility with specific MRI protocols and equipment in clinical settings to ensure patient safety.
What regulatory clearance does the Ionosit Base Liner hold, and how is it classified?
The Ionosit Base Liner holds FDA 510(k) clearance (K935689) with a Substantially Equivalent determination, indicating it is classified as a Class II device under FDA regulations (872.3310). This classification covers dental coatings, filling materials, and resins, aligning with its intended use as a stress-reducing liner.