Cleared Traditional

K020242 - EMULATE FAST SET AND EMULATE REGULAR SET (FDA 510(k) Clearance)

K020242 · Cavex Holland BV · Dental device

Apr 2002

Decision

84d

Days

Class 2

Risk

K020242 is an FDA 510(k) clearance for the EMULATE FAST SET AND EMULATE REGULAR SET. This device is classified as a Material, Impression (Class II - Special Controls, product code ELW).

Submitted by Cavex Holland BV (Haarlem, NL). The FDA issued a Cleared decision on April 17, 2002, 84 days after receiving the submission on January 23, 2002.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3660.

Submission Details

510(k) Number	K020242 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 23, 2002
Decision Date	April 17, 2002
Days to Decision	84 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement