Cleared Traditional

K950238 - GENTAL PULSE (FDA 510(k) Clearance)

K950238 · Parkell, Inc. · Dental device

May 1995

Decision

109d

Days

Class 2

Risk

K950238 is an FDA 510(k) clearance for the GENTAL PULSE. This device is classified as a Tester, Pulp (Class II - Special Controls, product code EAT).

Submitted by Parkell, Inc. (Farmingdale, US). The FDA issued a Cleared decision on May 9, 1995, 109 days after receiving the submission on January 20, 1995.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.1720.

Submission Details

510(k) Number	K950238 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 20, 1995
Decision Date	May 09, 1995
Days to Decision	109 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