Bioporta G

FDA 510(k) K023391 · Wieland Dental + Technik GmbH & Co. KG

Substantially Equivalent

510(k) numberK023391

Submission

Device name
Bioporta G
Applicant
Wieland Dental + Technik GmbH & Co. KG
Pforzheim, DE
Received
October 9, 2002
Decision date
December 10, 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 Bioporta G cleared by the FDA?

Bioporta G (K023391) received a 510(k) decision of Substantially Equivalent on December 10, 2002, 62 days after the submission was received.

What is the product code of K023391?

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