Cleared Traditional

K982050 - MODEL MS-2 HANDPIECE (FDA 510(k) Clearance)

K982050 · Parkell, Inc. · Dental device

Sep 1998

Decision

83d

Days

Class 1

Risk

K982050 is an FDA 510(k) clearance for the MODEL MS-2 HANDPIECE. This device is classified as a Handpiece, Air-powered, Dental (Class I - General Controls, product code EFB).

Submitted by Parkell, Inc. (Farmingdale, US). The FDA issued a Cleared decision on September 2, 1998, 83 days after receiving the submission on June 11, 1998.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number	K982050 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 11, 1998
Decision Date	September 02, 1998
Days to Decision	83 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF