FDA Product Code LFC: Device, Caries Detection
Leading manufacturers include Inter-Med/Vista Dental Products, GreenMark Biomedical, Inc. and Incisive Technologies Pty, Ltd..
17
Total
17
Cleared
107d
Avg days
1979
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Device, Caries Detection Devices (Product Code LFC)
17 devices
Cleared
May 16, 2023
BlueCheck™ Caries Detection & Monitoring
Incisive Technologies Pty, Ltd.
Dental
265d
Cleared
Mar 29, 2021
LumiCare Caries Diagnostic Rinse
GreenMark Biomedical, Inc.
Dental
385d
Cleared
Mar 11, 2020
Vista Dyes
Inter-Med/Vista Dental Products
Dental
89d
About Product Code LFC - Regulatory Context
510(k) Submission Activity
17 total 510(k) submissions under product code LFC since 1979, with 17 receiving FDA clearance (average review time: 107 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.