Talladium Tilite Ceramic Alloy

FDA 510(k) K894085 · Talladium, Inc.

Substantially Equivalent

510(k) numberK894085

Submission

Device name
Talladium Tilite Ceramic Alloy
Applicant
Talladium, Inc.
Valencia, CA, US
Received
June 8, 1989
Decision date
December 20, 1989
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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Questions and answers

When was Talladium Tilite Ceramic Alloy cleared by the FDA?

Talladium Tilite Ceramic Alloy (K894085) received a 510(k) decision of Substantially Equivalent on December 20, 1989, 195 days after the submission was received.

What is the product code of K894085?

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