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FDA 510(k)

LumiCera

K-Number: K260170 · 2026-01-21

ApplicantHangzhou SHINING3D Dental Technology Co., Ltd.
Decision Date2026-01-21
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LumiCera is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou SHINING3D Dental Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-01-21 under 510(k) number K260170. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LumiCera?

LumiCera is a medical device that received FDA 510(k) clearance on 2026-01-21. The listed applicant is Hangzhou SHINING3D Dental Technology Co., Ltd.. The 510(k) number is K260170.

When did LumiCera receive FDA 510(k) clearance?

LumiCera received FDA 510(k) clearance on 2026-01-21, under 510(k) number K260170.

Who is the listed applicant for LumiCera?

The FDA 510(k) record lists Hangzhou SHINING3D Dental Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LumiCera?

The FDA product code for LumiCera is EBF.

Other records listing Hangzhou SHINING3D Dental Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261356Dura-CrownK261261Dura-ArchK253053Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)K250946Denture Base Resin DT20

Related Devices (Code: EBF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K261246SRGC-06GC America, Inc.K261093DIAFILDiaDent Group InternationalK261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)DiaDent Group InternationalK260805Dual CoreVericom Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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