Cleared Traditional

K980568 - JUMBO GLASS IONOMER CEMENT
(FDA 510(k) Clearance)

K980568 · Centrix, Inc. · Dental device

Apr 1998

Decision

80d

Days

Class 2

Risk

K980568 is an FDA 510(k) clearance for the JUMBO GLASS IONOMER CEMENT. 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 April 30, 1998, 80 days after receiving the submission on February 9, 1998.

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

Submission Details

510(k) Number	K980568 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 09, 1998
Decision Date	April 30, 1998
Days to Decision	80 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement