Cleared Traditional

K922638 - TEMPIT-E (FDA 510(k) Clearance)

K922638 · Centrix, Inc. · Dental device

Aug 1992

Decision

97d

Days

Class 2

Risk

K922638 is an FDA 510(k) clearance for the TEMPIT-E. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).

Submitted by Centrix, Inc. (Shelton, US). The FDA issued a Cleared decision on August 10, 1992, 97 days after receiving the submission on May 5, 1992.

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

Submission Details

510(k) Number	K922638 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 05, 1992
Decision Date	August 10, 1992
Days to Decision	97 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement