Cleared Traditional

K032626 - PERMAQUICK SE BONDING SYSTEM (FDA 510(k) Clearance)

K032626 · Ultradent Products, Inc. · Dental device

Dec 2003

Decision

99d

Days

Class 2

Risk

K032626 is an FDA 510(k) clearance for the PERMAQUICK SE BONDING SYSTEM. This device is classified as a Agent, Tooth Bonding, Resin (Class II - Special Controls, product code KLE).

Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on December 3, 2003, 99 days after receiving the submission on August 26, 2003.

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

Submission Details

510(k) Number	K032626 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 26, 2003
Decision Date	December 03, 2003
Days to Decision	99 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement