Cleared Traditional

K102821 - DISCOVRED

K102821 is an FDA 510(k) clearance for DISCOVRED, manufactured by Phoenix Dental, Inc.. The device is a Class 2 Dental device with product code LFC cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K102821 · Phoenix Dental, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2011
Decision
164d
Days
Class 2
Risk

K102821 is an FDA 510(k) clearance for the DISCOVRED. Classified as Device, Caries Detection (product code LFC), Class II - Special Controls.

Submitted by Phoenix Dental, Inc. (Fenton, US). The FDA issued a Cleared decision on March 11, 2011 after a review of 164 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Phoenix Dental, Inc. devices

FDA 510(k) Submission Details - K102821

510(k) Number K102821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2010
Decision Date March 11, 2011
Days to Decision 164 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 127d · This submission: 164d
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 K102821.
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