Heraenium Ca

FDA 510(k) K851515 · Heraeus Dental Gold Corp.

Substantially Equivalent

510(k) numberK851515

Submission

Device name
Heraenium Ca
Applicant
Heraeus Dental Gold Corp.
Queens Village, NY, US
Received
April 15, 1985
Decision date
September 23, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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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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

More from American Dent-All, Inc.

510(k)DeviceDecision
K851872Blengold SpecialEJT · Traditional 07/02/1985SE
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Questions and answers

When was Heraenium Ca cleared by the FDA?

Heraenium Ca (K851515) received a 510(k) decision of Substantially Equivalent on September 23, 1985, 161 days after the submission was received.

What is the product code of K851515?

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