Cleared Traditional

THERMIQUE

K022097 · Parkell, Inc. · Dental
Sep 2002
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K022097 is an FDA 510(k) clearance for the THERMIQUE, a Tester, Pulp (Class II — Special Controls, product code EAT), submitted by Parkell, Inc. (Farmingdale, US). The FDA issued a Cleared decision on September 6, 2002, 71 days after receiving the submission on June 27, 2002. This device falls under the Dental review panel. Regulated under 21 CFR 872.1720.

Submission Details

510(k) Number K022097 FDA.gov
FDA Decision Cleared SESE
Date Received June 27, 2002
Decision Date September 06, 2002
Days to Decision 71 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EAT — Tester, Pulp
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.1720

Similar Devices — EAT Tester, Pulp

All 21
ELEMENTS DIAGNOSTIC UNIT
K021298 · Sybron Endo/Analytic · Jun 2002
PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT
K012427 · Specialites Septodont · Oct 2001
CHILLIT
K011666 · Heatshield, Inc. · Aug 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