Cleared Traditional

K973200 - CARIES STAIN

K973200 is the FDA 510(k) clearance for CARIES STAIN by Parkell, Inc.. It is a Class 2 Dental device (product code LFC) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K973200 · Parkell, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1997
Decision
72d
Days
Class 2
Risk

K973200 is an FDA 510(k) clearance for the CARIES STAIN. Classified as Device, Caries Detection (product code LFC), Class II - Special Controls.

Submitted by Parkell, Inc. (Farmingdale, US). The FDA issued a Cleared decision on November 6, 1997 after a review of 72 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 Parkell, Inc. devices

Submission Details

510(k) Number K973200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1997
Decision Date November 06, 1997
Days to Decision 72 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 127d · This submission: 72d
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

All 7
Devices cleared under the same product code (LFC) and FDA review panel - the closest regulatory comparables to K973200.
LumiCare Caries Diagnostic Rinse
K200601 · GreenMark Biomedical, Inc. · Mar 2021
Vista Dyes
K193447 · Inter-Med/Vista Dental Products · Mar 2020
CARIES DETECTOR
K012733 · Kuraray Medical, Inc. · Sep 2001
PULPDENT SNOOP
K964430 · Pulpdent Corp. · Jan 1997
TEAM CARIES INDICATOR
K963927 · Centrix, Inc. · Nov 1996
SEEK
K953526 · Ultradent Products, Inc. · Sep 1995