Cleared Traditional

K984013 - PLANMECA INTRACAM STATION
(FDA 510(k) Clearance)

K984013 · Planmeca Oy · Dental

Jan 1999

Decision

76d

Days

Class 1

Risk

K984013 is an FDA 510(k) clearance for the PLANMECA INTRACAM STATION, a Unit, Operative Dental (Class I — General Controls, product code EIA), submitted by Planmeca Oy (Helsinki, FI). The FDA issued a Cleared decision on January 26, 1999, 76 days after receiving the submission on November 11, 1998. This device falls under the Dental review panel. Regulated under 21 CFR 872.6640.

Submission Details

510(k) Number	K984013 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 11, 1998
Decision Date	January 26, 1999
Days to Decision	76 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement