FDA Product Code QNF: Laser Activator For Polymerization
Intended To Polymerize Dental Restorative Resins
Leading manufacturers include CAO Group, Inc. and Lumendo AG.
2
Total
2
Cleared
125d
Avg days
2020
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Laser Activator For Polymerization Devices (Product Code QNF)
2 devices
Cleared
Nov 02, 2023
Fibercure
Lumendo AG
Dental
112d
Cleared
Nov 24, 2020
Monet Curing Laser
CAO Group, Inc.
Dental
138d
About Product Code QNF - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code QNF since 2020, with 2 receiving FDA clearance (average review time: 125 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.