Cleared Traditional

PM2002 PROLINE, PM2002 PROLINE EC

K923461 · Planmeca USA, Inc. · Dental

Dec 1992

Decision

160d

Days

Class 1

Risk

About This 510(k) Submission

K923461 is an FDA 510(k) clearance for the PM2002 PROLINE, PM2002 PROLINE EC, a Chair, Dental, With Operative Unit (Class I — General Controls, product code KLC), submitted by Planmeca USA, Inc. (Finland, FI). The FDA issued a Cleared decision on December 21, 1992, 160 days after receiving the submission on July 14, 1992. This device falls under the Dental review panel. Regulated under 21 CFR 872.6250.

Submission Details

510(k) Number	K923461 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 14, 1992
Decision Date	December 21, 1992
Days to Decision	160 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement