Ceranum 82

FDA 510(k) K023197 · Sb Lucius, Inc.

Substantially Equivalent

510(k) numberK023197

Submission

Device name
Ceranum 82
Applicant
Sb Lucius, Inc.
Anaheim, CA, US
Received
September 25, 2002
Decision date
November 5, 2002
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EJT – Alloy, Gold-Based Noble Metal
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3060
Specialty
Dental

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Questions and answers

When was Ceranum 82 cleared by the FDA?

Ceranum 82 (K023197) received a 510(k) decision of Substantially Equivalent on November 5, 2002, 41 days after the submission was received.

What is the product code of K023197?

The FDA product code is EJT – Alloy, Gold-Based Noble Metal, a Class II (moderate risk) device regulated under 21 CFR 872.3060.