Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite

FDA 510(k) K201010 · Nobio , Ltd.

Substantially Equivalent

510(k) numberK201010

Submission

Device name
Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite
Applicant
Nobio , Ltd.
Kadima, IL
Received
April 17, 2020
Decision date
August 14, 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

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

More from Hangzhou SHINING3D Dental Technology Co., Ltd.

510(k)DeviceDecision
K183391Novidia Universal BondKLE · Traditional 09/24/2019SE
K182921Infinix Universal CompositeEBF · Traditional 09/13/2019SE
K182714Novidia Bulk Fill Flow CompositeEBF · Traditional 07/12/2019SE
K182580Novidia Flowable CompositeEBF · Traditional 07/03/2019SE

Questions and answers

When was Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite cleared by the FDA?

Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite (K201010) received a 510(k) decision of Substantially Equivalent on August 14, 2020, 119 days after the submission was received.

What is the product code of K201010?

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