Ceranum 50
510(k) K023199
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK023199 | Date4 Nov 2002 | 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- Withdrawn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, 22 Sep 2026
Ceranum 50 is a gold-based noble metal alloy classified as a dental device. It is intended for use in clinical dental applications as a precious metal alloy.
This device is regulated under 21 CFR 872.3060 and has received FDA 510(k) clearance under K023199. It is manufactured by Sb Lucius, Inc. and is categorized as a Class II medical device.
Other devices from Sb Lucius, Inc.
Questions
AI-generated answers, 22 Sep 2026
What is the intended use of Ceranum 50?
Ceranum 50 is a gold-based noble metal alloy specifically designed for use in clinical dental applications. It serves as a restorative material within the dental field.
What is the regulatory status of this dental alloy?
Ceranum 50 is classified as a Class II medical device under 21 CFR 872.3060. It has received FDA 510(k) clearance under the number K023199, confirming it is substantially equivalent to legally marketed predicate devices.
Who is the manufacturer of Ceranum 50?
This device is manufactured by Sb Lucius, Inc., located in Anaheim, California. The company is the official applicant for the FDA 510(k) clearance associated with this product.