Cleared Traditional

K983668 - MODIFICATION OF PQ1 (FDA 510(k) Clearance)

K983668 · Ultradent Products, Inc. · Dental device

Nov 1998

Decision

42d

Days

Class 2

Risk

K983668 is an FDA 510(k) clearance for the MODIFICATION OF PQ1. 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 November 30, 1998, 42 days after receiving the submission on October 19, 1998.

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

Submission Details

510(k) Number	K983668 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 19, 1998
Decision Date	November 30, 1998
Days to Decision	42 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement