Nico Dental Alloy

FDA 510(k) K924716 · Co-Nick Alloys (India) , Ltd.

Substantially Equivalent

510(k) numberK924716

Submission

Device name
Nico Dental Alloy
Applicant
Co-Nick Alloys (India) , Ltd.
Sunnyvale, CA, US
Received
September 21, 1992
Decision date
January 21, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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

Other 510(k)s with product code EJH

510(k)DeviceApplicantDecision
K123929Begopal+EJH · Abbreviated Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO03/14/2013SE
K040180Continum VEJH · Traditional Aalba Dent, Inc.03/04/2004SE
K040179ContinumEJH · Traditional Aalba Dent, Inc.03/03/2004SE
K033356Verasoft EsEJH · Traditional Aalba Dent, Inc.12/30/2003SE
K033045Dream Bond, Dreamcast Chrome, Dreamcast V, Dream Flexicast, Dream LithecastEJH · Traditional American Green Dent. Mfg, Inc.12/23/2003SE
K032136Wirobond CEJH · Traditional Bego U.S.A.09/04/2003SE
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

Questions and answers

When was Nico Dental Alloy cleared by the FDA?

Nico Dental Alloy (K924716) received a 510(k) decision of Substantially Equivalent on January 21, 1994, 487 days after the submission was received.

What is the product code of K924716?

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