Neocast C, V, S
510(k) K950951
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK950951 | Date23 Mar 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- Withdrawn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
- EJH
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3710
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Neocast C, V, S is a nickel-chromium base dental casting alloy used for fabricating dental restorations. This alloy is designed for precision casting of crowns, bridges, and other dental prosthetics, providing mechanical strength and biocompatibility for long-term oral use.
These alloys are supplied as reusable dental casting materials, intended for use in dental laboratories. They are classified as Class II devices under FDA regulations and require traditional 510(k) clearance. The alloys are non-sterile and must be handled in accordance with dental laboratory protocols, with appropriate storage to prevent contamination.
Other devices from Neodontics, Inc.
Questions
AI-generated answers, 19 Sep 2026
What types of dental restorations can the Neocast C, V, S alloy be used to fabricate, and why is it suitable for these applications?
The Neocast C, V, S alloy is specifically designed for precision casting of dental crowns, bridges, and other dental prosthetics. Its suitability comes from its nickel-chromium base composition, which provides a balance of mechanical strength and biocompatibility—critical for long-term oral use where durability and patient tolerance are essential.
Is the Neocast C, V, S alloy intended for direct patient use, or is it meant for dental laboratories only?
The Neocast C, V, S alloy is exclusively intended for use in dental laboratories. It is supplied as a reusable casting material and must be processed there before being used to fabricate restorations for patients. This aligns with standard dental laboratory protocols.
How should the Neocast C, V, S alloy be stored to ensure its integrity and prevent contamination?
Since the Neocast C, V, S alloy is non-sterile, it must be stored in a clean, dry environment following dental laboratory protocols to avoid contamination. Proper storage conditions are essential to maintain its quality and usability for precision casting applications.
What regulatory pathway was followed for the FDA clearance of the Neocast C, V, S alloy, and what does this mean for its use?
The Neocast C, V, S alloy underwent a traditional 510(k) clearance process through the FDA, classified as a Class II device under dental regulations. This means it was determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets established safety and performance standards for dental casting alloys.
Are there different models or variants of the Neocast C, V, S alloy, and if so, how do they differ?
The Neocast C, V, S alloy is listed as a single product line with three variants (C, V, S), but the data does not specify distinct differences between them beyond their classification as a nickel-chromium base alloy. Clinicians or laboratories should refer to manufacturer documentation for precise compositional or performance distinctions among these variants.