Cleared Traditional

K965060 - ULTRA-ETCH STAT (FDA 510(k) Clearance)

K965060 · Ultradent Products, Inc. · Dental device

Jan 1997

Decision

44d

Days

Class 2

Risk

K965060 is an FDA 510(k) clearance for the ULTRA-ETCH STAT. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).

Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on January 31, 1997, 44 days after receiving the submission on December 18, 1996.

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

Submission Details

510(k) Number	K965060 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 18, 1996
Decision Date	January 31, 1997
Days to Decision	44 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement