Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)

FDA 510(k) K253053 · Hangzhou SHINING3D Dental Technology Co., Ltd.

Substantially Equivalent

510(k) numberK253053

Submission

Device name
Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)
Applicant
Hangzhou SHINING3D Dental Technology Co., Ltd.
Hangzhou, CN
Received
September 22, 2025
Decision date
September 23, 2025
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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K262202Cerasmart ForteEBF · Traditional GC America, Inc.09/10/2026SE
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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
K261356Dura-CrownEBF · Special 04/27/2026SE
K261261Dura-ArchEBG · Traditional 04/17/2026SE
K260170LumiCeraEBF · Traditional 01/21/2026SE
K250946Denture Base Resin DT20EBI · Traditional 03/31/2025SE

Questions and answers

When was Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) cleared by the FDA?

Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) (K253053) received a 510(k) decision of Substantially Equivalent on September 23, 2025, 1 days after the submission was received.

What is the product code of K253053?

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