Cleared Traditional

K011330 - JP CAST 50
(FDA 510(k) Clearance)

K011330 · Jeneric/Pentron, Inc. · Dental

Jun 2001

Decision

51d

Days

Class 2

Risk

K011330 is an FDA 510(k) clearance for the JP CAST 50. This device is classified as 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 FDA review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number	K011330 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