Cleared Traditional

K932227 - AMELOGEN RESTORATIVE MATERIALS (FDA 510(k) Clearance)

K932227 · Ultradent Products, Inc. · Dental device

Sep 1993

Decision

129d

Days

Class 2

Risk

K932227 is an FDA 510(k) clearance for the AMELOGEN RESTORATIVE MATERIALS. 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 13, 1993, 129 days after receiving the submission on May 7, 1993.

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

Submission Details

510(k) Number	K932227 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 07, 1993
Decision Date	September 13, 1993
Days to Decision	129 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement