Cleared Traditional

K090941 - ADHESE ONE F (FDA 510(k) Clearance)

K090941 · Ivoclar Vivadent, Inc. · Dental device

Jul 2009

Decision

105d

Days

Class 2

Risk

K090941 is an FDA 510(k) clearance for the ADHESE ONE F. 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 July 17, 2009, 105 days after receiving the submission on April 3, 2009.

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

Submission Details

510(k) Number	K090941 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 03, 2009
Decision Date	July 17, 2009
Days to Decision	105 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement