Cleared Traditional

CARIES INDICATOR (K030807) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K030807 · Confi-Dental Products Co. · Dental device
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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

Submission Details

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
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.

Device Classification

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.