Pors On Lite
by Degussa Corp. 510(k)
Active
510(k) K972910
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK972910 | Date14 Oct 1997 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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, 6 Oct 2026
Pors On Lite is a dental alloy used by dental professionals for the fabrication of dental restorations. It is substantially equivalent to a predicate device and received traditional 510(k) clearance from the FDA. The device is classified as Class II under product code EJT and regulation number 872.3060.
It is intended for use in porcelain fused to metal crowns and full metal restorations. The device is manufactured by Degussa Corp. and supplied in a non-sterile, reusable form for dental laboratory use. Storage and handling should follow standard dental alloy practices as indicated by the manufacturer.
Other devices from Degussa AG
Questions
AI-generated answers, 6 Oct 2026
What is Pors On Lite used for?
Pors On Lite is a dental alloy intended for use in porcelain fused to metal crowns and full metal restorations, fabricated by dental professionals in a laboratory setting.
How is Pors On Lite supplied and is it sterile or reusable?
Pors On Lite is supplied in a non-sterile, reusable form for dental laboratory use, meaning it can be used multiple times following standard handling and storage practices.
What regulatory pathway was used for Pors On Lite and what is its classification?
Pors On Lite received traditional 510(k) clearance from the FDA and is classified as a Class II medical device under product code EJT and regulation number 872.3060.