AMBARINO High-Class

FDA 510(k) K222723 · Creamed GmbH & Co. Produktions- Und Handels KG

Substantially Equivalent

510(k) numberK222723

Submission

Device name
AMBARINO High-Class
Applicant
Creamed GmbH & Co. Produktions- Und Handels KG
Marburg, DE
Received
September 8, 2022
Decision date
September 9, 2022
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

Other 510(k)s with product code EBF

510(k)DeviceApplicantDecision
K262202Cerasmart ForteEBF · Traditional GC America, Inc.09/10/2026SE
K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)EBF · Traditional Guilin Kevin Peter Technology Co., Ltd.08/31/2026SE
K262228Transcend Bulk Fill Flowable CompositeEBF · Traditional Ultradent Products, Inc.07/01/2026SE
K261485Tetric plus Fill;Tetric plus FlowEBF · Traditional Ivoclar Vivadent, Inc.07/01/2026SE
K261246SRGC-06EBF · Traditional GC America, Inc.06/18/2026SE
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

Questions and answers

When was AMBARINO High-Class cleared by the FDA?

AMBARINO High-Class (K222723) received a 510(k) decision of Substantially Equivalent on September 9, 2022, 1 days after the submission was received.

What is the product code of K222723?

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