Cleared Traditional

K964809 - SPETEMP EF (FDA 510(k) Clearance)

K964809 · Ultradent Products, Inc. · Dental device

Jan 1997

Decision

34d

Days

Class 2

Risk

K964809 is an FDA 510(k) clearance for the SPETEMP EF. 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 January 2, 1997, 34 days after receiving the submission on November 29, 1996.

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

Submission Details

510(k) Number	K964809 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 29, 1996
Decision Date	January 02, 1997
Days to Decision	34 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement