Cleared Traditional

K953525 - ULTRADENT FLOWABLE COMPOSITE (FDA 510(k) Clearance)

K953525 · Ultradent Products, Inc. · Dental device

Aug 1995

Decision

32d

Days

Class 2

Risk

K953525 is an FDA 510(k) clearance for the ULTRADENT FLOWABLE COMPOSITE. 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 August 28, 1995, 32 days after receiving the submission on July 27, 1995.

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

Submission Details

510(k) Number	K953525 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 27, 1995
Decision Date	August 28, 1995
Days to Decision	32 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement