Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, Medi White Pearl

FDA 510(k) K170873 · Swissmeditec GmbH

Substantially Equivalent

510(k) numberK170873

Submission

Device name
Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, Medi White Pearl
Applicant
Swissmeditec GmbH
Finsterwald, CH
Received
March 23, 2017
Decision date
October 2, 2017
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

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 Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, Medi White Pearl cleared by the FDA?

Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, Medi White Pearl (K170873) received a 510(k) decision of Substantially Equivalent on October 2, 2017, 193 days after the submission was received.

What is the product code of K170873?

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