Cleared Traditional

K021298 - ELEMENTS DIAGNOSTIC UNIT

K021298 is an FDA 510(k) clearance for ELEMENTS DIAGNOSTIC UNIT, manufactured by Sybron Endo/Analytic. The device is a Class 2 Dental device with product code EAT cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K021298 · Sybron Endo/Analytic · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
56d
Days
Class 2
Risk

K021298 is an FDA 510(k) clearance for the ELEMENTS DIAGNOSTIC UNIT. Classified as Tester, Pulp (product code EAT), Class II - Special Controls.

Submitted by Sybron Endo/Analytic (Orange, US). The FDA issued a Cleared decision on June 19, 2002 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.1720 - 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 Sybron Endo/Analytic devices

FDA 510(k) Submission Details - K021298

510(k) Number K021298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2002
Decision Date June 19, 2002
Days to Decision 56 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
71d faster than avg
Panel avg: 127d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EAT Device Classification - Class 2, Special Controls

Product Code EAT Tester, Pulp
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1720
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 - EAT Tester, Pulp

All 11
Devices cleared under the same product code (EAT) and FDA review panel - the closest regulatory comparables to K021298.
THERMIQUE
K022097 · Parkell, Inc. · Sep 2002
PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT
K012427 · Specialites Septodont · Oct 2001
ENDO ANALYZER, MODEL 8005, MODIFIED
K990225 · Sybron Dental Specialties, Inc. · Feb 1999
ENDO ANALYZER, MODEL 8005
K973439 · Sybron Dental Specialties, Inc. · Dec 1997
SYSTEM B HEAT SOURCE
K970715 · Sybron Dental Specialties, Inc. · Apr 1997
TOUCH N' HEAT
K963862 · Sybron Dental Specialties, Inc. · Dec 1996