FDA Product Code LFC: Device, Caries Detection
Leading manufacturers include Kuraray Medical, Inc., Confi-Dental Products Co. and Inter-Med/Vista Dental Products.
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
Cleared
Jun 09, 2003
CARIES INDICATOR
Confi-Dental Products Co.
Dental
88d
Cleared
Sep 14, 2001
CARIES DETECTOR
Kuraray Medical, Inc.
Dental
31d
Cleared
Nov 06, 1997
CARIES STAIN
Parkell, Inc.
Dental
72d
Cleared
Jan 17, 1997
PULPDENT SNOOP
Pulpdent Corp.
Dental
73d
Cleared
Nov 15, 1996
TEAM CARIES INDICATOR
Centrix, Inc.
Dental
66d
Cleared
Sep 05, 1995
SEEK
Ultradent Products, Inc.
Dental
40d
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.