Will Ceram Lite-Cast B

FDA 510(k) K800371 · Williams Gold Refining Co., Inc.

Substantially Equivalent

510(k) numberK800371

Submission

Device name
Will Ceram Lite-Cast B
Applicant
Williams Gold Refining Co., Inc.
Mchenry, IL, US
Received
February 20, 1980
Decision date
February 28, 1980
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 Will Ceram Lite-Cast B cleared by the FDA?

Will Ceram Lite-Cast B (K800371) received a 510(k) decision of Substantially Equivalent on February 28, 1980, 8 days after the submission was received.

What is the product code of K800371?

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