VarseoSmile Crown plus

FDA 510(k) K201668 · Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG

Substantially Equivalent

510(k) numberK201668

Submission

Device name
VarseoSmile Crown plus
Applicant
Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG
Bremen, DE
Received
June 19, 2020
Decision date
June 23, 2020
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

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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K261093DiafilEBF · Traditional DiaDent Group International06/02/2026SE
K261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW…EBF · Traditional DiaDent Group International05/19/2026SE
K260805Dual CoreEBF · Traditional Vericom Co., Ltd.05/11/2026SE
K261357Grandio disc multicolorEBF · Traditional Voco GmbH04/27/2026SE
K261356Dura-CrownEBF · Special Hangzhou SHINING3D Dental Technology Co., Ltd.04/27/2026SE

More from Hangzhou SHINING3D Dental Technology Co., Ltd.

510(k)DeviceDecision
K233596VarseoSmile TriniQEBF · Traditional 11/09/2023SE

Questions and answers

When was VarseoSmile Crown plus cleared by the FDA?

VarseoSmile Crown plus (K201668) received a 510(k) decision of Substantially Equivalent on June 23, 2020, 4 days after the submission was received.

What is the product code of K201668?

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