Ceracast-V

FDA 510(k) K030416 · Mountain Medico, Inc.

Substantially Equivalent

510(k) numberK030416

Submission

Device name
Ceracast-V
Applicant
Mountain Medico, Inc.
Upland, CA, US
Received
February 10, 2003
Decision date
April 14, 2003
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

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Questions and answers

When was Ceracast-V cleared by the FDA?

Ceracast-V (K030416) received a 510(k) decision of Substantially Equivalent on April 14, 2003, 63 days after the submission was received.

What is the product code of K030416?

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