Cleared Traditional

K921598 - ULTRADENT PRODUCT PIT & FISSURE SEALANT PROD LINE (FDA 510(k) Clearance)

K921598 · Ultradent Products, Inc. · Dental device

Sep 1992

Decision

159d

Days

Class 2

Risk

K921598 is an FDA 510(k) clearance for the ULTRADENT PRODUCT PIT & FISSURE SEALANT PROD LINE. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).

Submitted by Ultradent Products, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on September 9, 1992, 159 days after receiving the submission on April 3, 1992.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number	K921598 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 03, 1992
Decision Date	September 09, 1992
Days to Decision	159 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement