Cleared Traditional

CEMENT IT! UNIVERSAL C&B

K000173 · Jeneric/Pentron, Inc. · Dental
Feb 2000
Decision
40d
Days
Class 2
Risk

About This 510(k) Submission

K000173 is an FDA 510(k) clearance for the CEMENT IT! UNIVERSAL C&B, a Cement, Dental (Class II — Special Controls, product code EMA), submitted by Jeneric/Pentron, Inc. (Wallingford, US). The FDA issued a Cleared decision on February 29, 2000, 40 days after receiving the submission on January 20, 2000. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K000173 FDA.gov
FDA Decision Cleared SESE
Date Received January 20, 2000
Decision Date February 29, 2000
Days to Decision 40 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

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