Cleared Traditional

K950237 - DIGITEST

K950237 is an FDA 510(k) clearance for DIGITEST, manufactured by Parkell, Inc.. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K950237

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.

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 10
Devices cleared under the same product code (EAT) and FDA review panel - the closest regulatory comparables to K950237.
SYSTEM B HEAT SOURCE
K970715 · Sybron Dental Specialties, Inc. · Apr 1997
TOUCH N' HEAT
K963862 · Sybron Dental Specialties, Inc. · Dec 1996
ORTHO-ICE
K960799 · Ultimate Wireforms, Inc. · May 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