Finesse Low-Fusing Porcelain System
510(k) K954761
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK954761 | Date2 Nov 1995 | 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- Withdrawn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
- EIH
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.6660
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Finesse Low-Fusing Porcelain System is a dental porcelain material designed for dental restorations. Classified under product code EIH as a powder-based porcelain system, it is intended for use in fabricating dental crowns, inlays, onlays, and veneers. This system is engineered to fuse at lower temperatures, facilitating precise and controlled application in clinical settings. Its formulation supports durable, aesthetically pleasing restorations with improved bonding properties to dental substrates.
This system is supplied as a powder and is used in dental laboratories for creating custom restorations. It requires specific handling and application techniques, including mixing, application, and curing at low-fusing temperatures. The device is classified as Class II under special controls and has received FDA 510(k) clearance (K954761) for use in dental procedures. Storage conditions and sterility are not specified in the data, but adherence to manufacturer guidelines is essential for optimal performance and safety.
Other devices from Dentsply Intl.
Questions
AI-generated answers, 1 Oct 2026
What types of dental restorations can the Finesse Low-Fusing Porcelain System create?
The Finesse Low-Fusing Porcelain System is specifically designed for fabricating dental crowns, inlays, onlays, and veneers. Its low-fusing formulation allows for precise application at reduced temperatures, making it suitable for these custom restorations in dental laboratories. The system’s improved bonding properties also enhance durability and aesthetic outcomes.
How is the Finesse Low-Fusing Porcelain System supplied, and what are its key handling requirements?
This system is supplied as a powder, intended for use exclusively in dental laboratories. Proper handling involves careful mixing, application, and curing at the specified low-fusing temperatures to ensure optimal fusion and restoration integrity. Adherence to manufacturer guidelines is critical for achieving consistent results.
Is the Finesse Low-Fusing Porcelain System single-use or reusable?
The Finesse Low-Fusing Porcelain System is designed for single-use in creating individual restorations. Once mixed and applied, the material undergoes a chemical change during curing, making it unsuitable for reuse. Each batch should be prepared fresh for a new restoration to maintain performance and sterility.
What distinguishes the Finesse Low-Fusing Porcelain System from other porcelain materials?
Unlike traditional porcelain systems requiring higher firing temperatures, the Finesse system is engineered to fuse at lower temperatures, reducing thermal stress on substrates and improving precision. This feature, combined with its powder-based formulation and enhanced bonding properties, supports more controlled application and aesthetically pleasing, durable restorations.
Are there specific storage recommendations for the Finesse Low-Fusing Porcelain System?
While storage conditions are not explicitly detailed in the provided data, the manufacturer’s guidelines should be followed to preserve the system’s integrity. Proper storage typically involves keeping the powder in a dry, sealed environment away from moisture and extreme temperatures. Always refer to the accompanying documentation for precise instructions.