Cleared Traditional

K960697 - ULTRACID AND ULTRACID F DISINFECTING SOLUTION (FDA 510(k) Clearance)

K960697 · Ultradent Products, Inc. · Dental device

May 1996

Decision

76d

Days

Class 2

Risk

K960697 is an FDA 510(k) clearance for the ULTRACID AND ULTRACID F DISINFECTING SOLUTION. 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 May 6, 1996, 76 days after receiving the submission on February 20, 1996.

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

Submission Details

510(k) Number	K960697 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 20, 1996
Decision Date	May 06, 1996
Days to Decision	76 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement