Cleared Traditional

K924024 - ORTHO WAX
(FDA 510(k) Clearance)

K924024 · Heraeus Kulzer, Inc. · Dental

Nov 1992

Decision

98d

Days

Class 1

Risk

K924024 is an FDA 510(k) clearance for the ORTHO WAX. This device is classified as a Wax, Dental, Intraoral (Class I — General Controls, product code EGD).

Submitted by Heraeus Kulzer, Inc. (South Bend, US). The FDA issued a Cleared decision on November 17, 1992, 98 days after receiving the submission on August 11, 1992.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6890.

Submission Details

510(k) Number	K924024 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 11, 1992
Decision Date	November 17, 1992
Days to Decision	98 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement