Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)

FDA 510(k) K261695 · Guilin Kevin Peter Technology Co., Ltd.

Substantially Equivalent

510(k) numberK261695

Submission

Device name
Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)
Applicant
Guilin Kevin Peter Technology Co., Ltd.
Guilin, CN
Received
May 22, 2026
Decision date
August 31, 2026
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

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K262202Cerasmart ForteEBF · Traditional GC America, Inc.09/10/2026SE
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
K260152Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT)EBF · Traditional Mmtech Projetos Tecnologicos Importacao E…04/23/2026SE

More from Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda.

510(k)DeviceDecision
K261514Calcium Hydroxide Temporary Filling Material (KP-Cal)KIF · Traditional 08/25/2026SE
K261415Injectable Root Canal Sealer (KP-Root SP)KIF · Traditional 06/29/2026SE

Questions and answers

When was Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF) cleared by the FDA?

Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF) (K261695) received a 510(k) decision of Substantially Equivalent on August 31, 2026, 101 days after the submission was received.

What is the product code of K261695?

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