Cleared Traditional

K974282 - VITALESCENCE (FDA 510(k) Clearance)

K974282 · Ultradent Products, Inc. · Dental device

Jan 1998

Decision

76d

Days

Class 2

Risk

K974282 is an FDA 510(k) clearance for the VITALESCENCE. 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 29, 1998, 76 days after receiving the submission on November 14, 1997.

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

Submission Details

510(k) Number	K974282 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 14, 1997
Decision Date	January 29, 1998
Days to Decision	76 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement