Rastronics Portarem 20
510(k) K902287
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK902287 | Date9 Aug 1990 | 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- Withdrawn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, 21 Sep 2026
The Rastronics Portarem 20 is a dental device, classified as a Gold-Based Noble Metal Alloy. It is substantially equivalent to other devices in its class.
The device is supplied as a single unit, with a product code of EJT and a regulation number of 872.3060. It has been cleared by the FDA with a traditional clearance type, and is intended for use in dental applications. The device has a device class of 2, and its medical specialty description is Dental.
Other devices from Rastronics USA, Inc.
Questions
AI-generated answers, 21 Sep 2026
What is the Rastronics Portarem 20 used for?
The Rastronics Portarem 20 is intended for use in dental applications, as a gold-based noble metal alloy.
How is the Rastronics Portarem 20 supplied?
The device is supplied as a single unit.
What is the regulatory classification of the Rastronics Portarem 20?
The device has a device class of 2, and its medical specialty description is Dental, with a regulation number of 872.3060.