Cleared Traditional

K102821 - DISCOVRED

K102821 is the FDA 510(k) clearance for DISCOVRED by Phoenix Dental, Inc.. It is a Class 2 Dental device (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

Submission Details

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.

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.

Regulatory Peers - LFC Device, Caries Detection

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 STAIN
K973200 · Parkell, Inc. · Nov 1997
PULPDENT SNOOP
K964430 · Pulpdent Corp. · Jan 1997
SEEK
K953526 · Ultradent Products, Inc. · Sep 1995