Isosit N
510(k) K864710
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK864710 | Date10 Feb 1987 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- EBF
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3690
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Isosit N is a dental material classified as a denture base polymer (product code EBF), designed for use in complete denture prosthetics. It is a cross-linked polymer intended to provide durable, wear-resistant teeth for dental prostheses, ensuring longevity and stability in functional applications. The material is formulated to mimic natural tooth properties while maintaining structural integrity under occlusal forces.
This device is supplied as a reusable material for dental laboratory use, requiring preparation and processing by trained professionals. It is not sterile at time of shipment but is intended to be processed according to standard dental laboratory protocols. The Isosit N has received FDA 510(k) clearance (K864710) under the Traditional 510(k) review pathway, with a decision date of February 10, 1987. No additional regulatory markings or MRI safety classifications are specified in the available data.
Other devices from Ivoclar USA, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Isosit N used for in dental prosthetics?
The Isosit N is a cross-linked polymer specifically designed for use as a denture base material in complete denture prosthetics. Its formulation ensures durability and wear resistance, allowing it to withstand occlusal forces while closely mimicking the properties of natural teeth. This makes it ideal for creating long-lasting, functional dentures that maintain structural integrity over time.
How is the Isosit N supplied and prepared for use?
The Isosit N is supplied as a reusable material intended exclusively for dental laboratory use. It is not sterile at the time of shipment and must be processed according to standard dental laboratory protocols. Preparation involves following manufacturer guidelines to achieve the desired properties for denture fabrication, ensuring proper handling and processing by trained professionals.
Is the Isosit N intended for single-use or reusable applications?
The Isosit N is designed as a reusable material for dental laboratory use. Once processed into a denture base, it is intended to remain in the final prosthetic device, which is then used by patients. The material’s cross-linked polymer structure provides durability for repeated functional use in dentures.
What regulatory pathway does the Isosit N follow, and when was it cleared?
The Isosit N received FDA 510(k) clearance under the Traditional 510(k) review pathway, with a decision date of February 10, 1987. The clearance was granted as substantially equivalent to a predicate device, following a review by the Dental (DE) Advisory Committee. This pathway ensures compliance with U.S. regulatory standards for dental materials.
Does the Isosit N require any special handling or storage before processing?
While specific storage instructions are not detailed in the provided data, the Isosit N is intended for dental laboratory use and should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Since it is not sterile at shipment, it must be processed according to standard dental laboratory protocols to ensure proper sterility and functionality before use in denture fabrication.