Cleared Traditional

JP CAST 40

K011331 · Jeneric/Pentron, Inc. · Dental
Jun 2001
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K011331 is an FDA 510(k) clearance for the JP CAST 40, a Alloy, Gold-based Noble Metal (Class II — Special Controls, product code EJT), submitted by Jeneric/Pentron, Inc. (Wallingford, US). The FDA issued a Cleared decision on June 22, 2001, 51 days after receiving the submission on May 2, 2001. This device falls under the Dental review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number K011331 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 2001
Decision Date June 22, 2001
Days to Decision 51 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EJT — Alloy, Gold-based Noble Metal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3060

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