Miracle 98
510(k) K031010
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK031010 | Date25 Jun 2003 | 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- Withdrawn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
- EJT
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3060
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Miracle 98 is a gold-based noble metal alloy for clinical use, classified as a dental device. It is designed for use in dental applications as a material for restorations and prosthetics.
The device is supplied by Sb Lucius, Inc. and is authorized under FDA 510K clearance with product code EJT. It is regulated under number 872.3060 for gold-based alloys and precious metal alloys for clinical use.
Other devices from Sb Lucius, Inc.
Questions
AI-generated answers, 19 Sep 2026
What is the Miracle 98 device used for?
The Miracle 98 is a gold-based noble metal alloy designed for dental applications as a material for restorations and prosthetics.
How is the Miracle 98 device supplied?
The device is supplied by Sb Lucius, Inc., a manufacturer based in Anaheim, California.
What is the regulatory status of the Miracle 98?
The Miracle 98 has FDA 510K clearance with product code EJT and is regulated under number 872.3060 for gold-based alloys.
Is the Miracle 98 device sterile?
The device data does not specify whether the Miracle 98 is supplied sterile.
Can the Miracle 98 be reused or is it single-use?
The device data does not specify whether the Miracle 98 is designed for single-use or reuse.