Cleared Traditional

K030807 - CARIES INDICATOR

K030807 is an FDA 510(k) clearance for CARIES INDICATOR, manufactured by Confi-Dental Products Co.. The device is a Class 2 Dental device with product code LFC cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K030807 · Confi-Dental Products Co. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
88d
Days
Class 2
Risk

K030807 is an FDA 510(k) clearance for the CARIES INDICATOR. Classified as Device, Caries Detection (product code LFC), Class II - Special Controls.

Submitted by Confi-Dental Products Co. (Louisville, US). The FDA issued a Cleared decision on June 9, 2003 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.1740 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Confi-Dental Products Co. devices

FDA 510(k) Submission Details - K030807

510(k) Number K030807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2003
Decision Date June 09, 2003
Days to Decision 88 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 127d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LFC Device Classification - Class 2, Special Controls

Product Code LFC Device, Caries Detection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1740
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - LFC Device, Caries Detection

All 13
Devices cleared under the same product code (LFC) and FDA review panel - the closest regulatory comparables to K030807.
LumiCare Caries Diagnostic Rinse
K200601 · GreenMark Biomedical, Inc. · Mar 2021
Vista Dyes
K193447 · Inter-Med/Vista Dental Products · Mar 2020
SEE-IT CARIES DETECTOR
K060330 · Ronvig Dental Mfg. A/S · Apr 2006
CARIES DETECTOR
K012733 · Kuraray Medical, Inc. · Sep 2001
AMERICAN DENTAL PRODUCTS CARIES-DETECTOR PLUS
K994368 · American Dental Products, Inc. · Mar 2000
ORAL POTENTIAL METER (OPM)
K982105 · Pertec of Wisconsin, Inc. · Sep 1998