Cleared Traditional

JUMBO SILVER-REINFORCED GLASS IONOMER

K982665 · Centrix, Inc. · Dental
Sep 1998
Decision
46d
Days
Class 2
Risk

About This 510(k) Submission

K982665 is an FDA 510(k) clearance for the JUMBO SILVER-REINFORCED GLASS IONOMER, a Cement, Dental (Class II — Special Controls, product code EMA), submitted by Centrix, Inc. (Shelton, US). The FDA issued a Cleared decision on September 8, 1998, 46 days after receiving the submission on July 24, 1998. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K982665 FDA.gov
FDA Decision Cleared SESE
Date Received July 24, 1998
Decision Date September 08, 1998
Days to Decision 46 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EMA — Cement, Dental
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3275