FDA Product Code POW: Crown And Bridge, Long-term Temporary, Resin
For The Fabrication Of Long-term Temporary Crowns And Bridges
Leading manufacturers include Voco GmbH and Dental Manufacturing S.P.A.
2
Total
2
Cleared
78d
Avg days
2023
Since
Stable submission activity - 1 submissions in the last 2 years
Review times increasing: avg
96d
recently vs 60d historically
FDA 510(k) Cleared Crown And Bridge, Long-term Temporary, Resin Devices (Product Code POW)
2 devices
Cleared
Aug 05, 2026
Ruthinium Disc
Dental Manufacturing S.P.A
Dental
96d
Cleared
Jul 31, 2023
V-Print c&b temp
Voco GmbH
Dental
60d
About Product Code POW - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code POW since 2023, with 2 receiving FDA clearance (average review time: 78 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA 510(k) Review Time - POW Product Code
Recent submissions under POW have taken an average of 96 days to reach a decision - up from 60 days historically. Manufacturers should account for longer review timelines in current project planning.
POW devices are reviewed by the Dental panel. Browse all Dental devices →