Cleared Traditional

K994261 - ULTRATEMP TEMPORARY POLYCARBOXYLATE CEMENT (FDA 510(k) Clearance)

K994261 · Ultradent Products, Inc. · Dental device

Feb 2000

Decision

47d

Days

Class 2

Risk

K994261 is an FDA 510(k) clearance for the ULTRATEMP TEMPORARY POLYCARBOXYLATE CEMENT. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).

Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on February 2, 2000, 47 days after receiving the submission on December 17, 1999.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number	K994261 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 17, 1999
Decision Date	February 02, 2000
Days to Decision	47 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement