Porta Aurium, Model 2067

FDA 510(k) K012827 · Wieland Edelmetalle GmbH & Co.

Substantially Equivalent

510(k) numberK012827

Submission

Device name
Porta Aurium, Model 2067
Applicant
Wieland Edelmetalle GmbH & Co.
Pforzheim, DE
Received
August 23, 2001
Decision date
November 1, 2001
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 Porta Aurium, Model 2067 cleared by the FDA?

Porta Aurium, Model 2067 (K012827) received a 510(k) decision of Substantially Equivalent on November 1, 2001, 70 days after the submission was received.

What is the product code of K012827?

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