Gold Core Plus

FDA 510(k) K023499 · Pentron Laboratory Technologies

Substantially Equivalent

510(k) numberK023499

Submission

Device name
Gold Core Plus
Applicant
Pentron Laboratory Technologies
Wallingford, CT, US
Received
October 18, 2002
Decision date
January 13, 2003
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EJH – Alloy, Metal, Base
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3710
Specialty
Dental

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K040179ContinumEJH · Traditional Aalba Dent, Inc.03/03/2004SE
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K031627Nano-TicrownEJH · Traditional Nano-Write Corp.06/11/2003SE
K030632PD Casta-HEJH · Traditional Mountain Medico, Inc.05/07/2003SE
K030416Ceracast-VEJH · Traditional Mountain Medico, Inc.04/14/2003SE
K030161SuperbondEJH · Traditional American Dent-All, Inc.03/17/2003SE

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K023501Gold Core 35EJT · Traditional 12/18/2002SE
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Questions and answers

When was Gold Core Plus cleared by the FDA?

Gold Core Plus (K023499) received a 510(k) decision of Substantially Equivalent on January 13, 2003, 87 days after the submission was received.

What is the product code of K023499?

The FDA product code is EJH – Alloy, Metal, Base, a Class II (moderate risk) device regulated under 21 CFR 872.3710.