Cleared Traditional

K931084 - TEMPIT (FDA 510(k) Clearance)

K931084 · Centrix, Inc. · Dental device

May 1993

Decision

86d

Days

Class 2

Risk

K931084 is an FDA 510(k) clearance for the TEMPIT. 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 May 27, 1993, 86 days after receiving the submission on March 2, 1993.

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

Submission Details

510(k) Number	K931084 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 02, 1993
Decision Date	May 27, 1993
Days to Decision	86 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement