DeviceClearance

Product code POW— Dental

Ruthinium Disc

Classification name
Crown And Bridge, Long-Term Temporary, Resin
Device class
Class 2
Regulation
21 CFR 872.3770
Advisory panel
Dental
Total cleared
2
First cleared
Most recent

FDA classification definition

“For the fabrication of long-term temporary crowns and bridges”

— U.S. Food and Drug Administration, device classification record for product code POW under 21 CFR 872.3770, via openFDA

Market context for product code POW

FDA has cleared 2 devices under product code POW between 2023 and 2026, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code POW

Recent clearances under product code POW

Data sourced from openFDA. This site is unofficial and independent of the FDA.