Cleared Traditional

K024094 - 4 SEASONS (FDA 510(k) Clearance)

K024094 · Ivoclar Vivadent, Inc. · Dental device

Feb 2003

Decision

65d

Days

Class 2

Risk

K024094 is an FDA 510(k) clearance for the 4 SEASONS. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).

Submitted by Ivoclar Vivadent, Inc. (Amherst, US). The FDA issued a Cleared decision on February 14, 2003, 65 days after receiving the submission on December 11, 2002.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number	K024094 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 11, 2002
Decision Date	February 14, 2003
Days to Decision	65 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement