Zircos-Com

FDA 510(k) K190139 · Bioden Co., Ltd.

Substantially Equivalent

510(k) numberK190139

Submission

Device name
Zircos-Com
Applicant
Bioden Co., Ltd.
Seoul, KR
Received
January 29, 2019
Decision date
April 24, 2020
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EBF – Material, Tooth Shade, Resin
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3690
Specialty
Dental

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Questions and answers

When was Zircos-Com cleared by the FDA?

Zircos-Com (K190139) received a 510(k) decision of Substantially Equivalent on April 24, 2020, 451 days after the submission was received.

What is the product code of K190139?

The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.