Cleared Traditional

K923462 - DELIGHT
(FDA 510(k) Clearance)

K923462 · Planmeca USA, Inc. · Dental

Dec 1992

Decision

160d

Days

Class 1

Risk

K923462 is an FDA 510(k) clearance for the DELIGHT. This device is classified as a Light, Operating, Dental (Class I — General Controls, product code EAZ).

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 FDA review panel. Regulated under 21 CFR 872.4630.

Submission Details

510(k) Number	K923462 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