Cleared Traditional

K950237 - DIGITEST

K950237 is the FDA 510(k) clearance for DIGITEST by Parkell, Inc.. It is a Class 2 Dental device (product code EAT) cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K950237 · Parkell, Inc. · Dental device
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Jun 1995
Decision
140d
Days
Class 2
Risk

K950237 is an FDA 510(k) clearance for the DIGITEST. Classified as Tester, Pulp (product code EAT), Class II - Special Controls.

Submitted by Parkell, Inc. (Farmingdale, US). The FDA issued a Cleared decision on June 9, 1995 after a review of 140 days - within the typical 510(k) review window.

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: 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 Parkell, Inc. devices

Submission Details

510(k) Number K950237 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 1995
Decision Date June 09, 1995
Days to Decision 140 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 127d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 8
Devices cleared under the same product code (EAT) and FDA review panel - the closest regulatory comparables to K950237.
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
GENTAL PULSE
K950238 · Parkell, Inc. · May 1995
MODEL SK-14 STARTER KIT FOR DENTAL IONTOPHORESIS
K872039 · Life-Tech Intl., Inc. · Nov 1987
MODEL 6110B DENTAPHOR
K870118 · Life-Tech Intl., Inc. · Apr 1987