Cleared Traditional

K931867 - ULTRA-ETCH ENAMEL PREPARATION PRODUCT LINE (FDA 510(k) Clearance)

K931867 · Ultradent Products, Inc. · Dental device

Sep 1993

Decision

148d

Days

Class 2

Risk

K931867 is an FDA 510(k) clearance for the ULTRA-ETCH ENAMEL PREPARATION PRODUCT LINE. 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 September 9, 1993, 148 days after receiving the submission on April 14, 1993.

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

Submission Details

510(k) Number	K931867 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 14, 1993
Decision Date	September 09, 1993
Days to Decision	148 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement