Cleared Traditional

K013584 - EXCITE SELF ETCH (FDA 510(k) Clearance)

K013584 · Ivoclar Vivadent, Inc. · Dental device

Jan 2002

Decision

90d

Days

Class 2

Risk

K013584 is an FDA 510(k) clearance for the EXCITE SELF ETCH. This device is classified as a Agent, Tooth Bonding, Resin (Class II - Special Controls, product code KLE).

Submitted by Ivoclar Vivadent, Inc. (Amherst, US). The FDA issued a Cleared decision on January 28, 2002, 90 days after receiving the submission on October 30, 2001.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number	K013584 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 30, 2001
Decision Date	January 28, 2002
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement