Cleared Traditional

K002843 - SULTAN SENSITEMP RESIN TEMPORARY CEMENT, MODEL 70010
(FDA 510(k) Clearance)

K002843 · Sultan Chemists, Inc. · Dental device

Nov 2000

Decision

64d

Days

Class 2

Risk

K002843 is an FDA 510(k) clearance for the SULTAN SENSITEMP RESIN TEMPORARY CEMENT, MODEL 70010. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).

Submitted by Sultan Chemists, Inc. (Kansas City, US). The FDA issued a Cleared decision on November 15, 2000, 64 days after receiving the submission on September 12, 2000.

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

Submission Details

510(k) Number	K002843 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 12, 2000
Decision Date	November 15, 2000
Days to Decision	64 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement