Precise Alloy, Metal, Base
by Allan Schulman, D.D.S., M.S.
510(k) K970827
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK970827 | Date16 Apr 1997 | 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- Withdrawn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
- Full name
- Precise
- 510(k) Number
- FDA Product Code
- EJH
- FDA applicant
- Allan Schulman,D.D.S., M.S.
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3710
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Precise Alloy, Metal, Base is a dental base metal alloy designed for use in dental restorative procedures. This device falls under the classification of dental alloys, specifically intended for applications requiring durable and biocompatible materials in fixed prosthodontics, such as crowns, bridges, or inlays. Its composition adheres to regulatory standards for dental base metal alloys, ensuring compatibility with oral tissues and long-term performance.
This device is supplied as a reusable material for dental professionals in clinical settings. It is classified under FDA product code EJH and is subject to the special controls for dental base metal alloys, including compliance with regulatory requirements outlined in 21 CFR 872.3710. The alloy is intended for single-use applications in restorative dentistry, though its reusable nature refers to the material stock rather than individual patient use. No specific sterility or MRI safety information is provided, but it is governed by FDA 510(k) clearance (K970827) under the Dental Advisory Committee, with a decision date of April 16, 1997.
Questions
AI-generated answers, 1 Oct 2026
What is the Precise Alloy Base Metal used for in dental procedures?
The Precise Alloy Base Metal is designed specifically for dental restorative procedures, particularly in fixed prosthodontics. This includes applications such as crowns, bridges, and inlays, where a durable and biocompatible material is required to ensure long-term performance and compatibility with oral tissues. Its composition adheres to regulatory standards, making it suitable for these critical dental applications.
Is the Precise Alloy Base Metal supplied as single-use or reusable?
The Precise Alloy Base Metal is supplied as reusable material stock for dental professionals. However, it is intended for single-use applications with individual patients. This means the material itself can be used repeatedly in the clinical setting, but each patient application requires a fresh portion of the alloy to ensure sterility and safety.
What regulatory standards does the Precise Alloy Base Metal comply with?
The Precise Alloy Base Metal complies with FDA regulatory standards for dental base metal alloys, specifically under product code EJH and the special controls outlined in 21 CFR 872.3710. It has received FDA 510(k) clearance (K970827) through the Dental Advisory Committee, ensuring it meets the necessary requirements for biocompatibility, durability, and performance in dental restorative procedures.
Are there any specific sterility or MRI safety considerations for the Precise Alloy Base Metal?
The provided documentation does not specify any particular sterility requirements or MRI safety information for the Precise Alloy Base Metal. However, since it is intended for single-use patient applications, standard dental sterilization protocols should be followed when preparing the material for use. Always consult manufacturer guidelines for proper handling and safety.
How is the Precise Alloy Base Metal classified under FDA regulations?
The Precise Alloy Base Metal is classified under FDA product code EJH and falls under the classification of dental base metal alloys. It is governed by special controls, including compliance with 21 CFR 872.3710, and has been determined to be substantially equivalent to a predicate device through the traditional 510(k) clearance process. This classification ensures it meets the necessary standards for safety and effectiveness in dental applications.