Cleared Traditional

K060330 - SEE-IT CARIES DETECTOR

K060330 is an FDA 510(k) clearance for SEE-IT CARIES DETECTOR, manufactured by Ronvig Dental Mfg. A/S. The device is a Class 2 Dental device with product code LFC cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K060330 · Ronvig Dental Mfg. A/S · Dental device
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Apr 2006
Decision
57d
Days
Class 2
Risk

K060330 is an FDA 510(k) clearance for the SEE-IT CARIES DETECTOR. Classified as Device, Caries Detection (product code LFC), Class II - Special Controls.

Submitted by Ronvig Dental Mfg. A/S (Daugaard, DK). The FDA issued a Cleared decision on April 7, 2006 after a review of 57 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 Ronvig Dental Mfg. A/S devices

FDA 510(k) Submission Details - K060330

510(k) Number K060330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2006
Decision Date April 07, 2006
Days to Decision 57 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
70d faster than avg
Panel avg: 127d · This submission: 57d
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 K060330.
BlueCheck™ Caries Detection & Monitoring
K222560 · Incisive Technologies Pty, Ltd. · May 2023
LumiCare Caries Diagnostic Rinse
K200601 · GreenMark Biomedical, Inc. · Mar 2021
Vista Dyes
K193447 · Inter-Med/Vista Dental Products · Mar 2020
CARIES INDICATOR
K030807 · Confi-Dental Products Co. · Jun 2003
CARIES DETECTOR
K012733 · Kuraray Medical, Inc. · Sep 2001
AMERICAN DENTAL PRODUCTS CARIES-DETECTOR PLUS
K994368 · American Dental Products, Inc. · Mar 2000