LumiCera
K-Number: K260170 · 2026-01-21
Decision Date2026-01-21
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
LumiCera is a medical device manufactured by Hangzhou SHINING3D Dental Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-01-21 under approval 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. It is manufactured by Hangzhou SHINING3D Dental Technology Co., Ltd.. The 510(k) number is K260170.
When was LumiCera approved by the FDA?
LumiCera received FDA 510(k) clearance on 2026-01-21, under approval number K260170.
What company makes LumiCera?
LumiCera is manufactured by Hangzhou SHINING3D Dental Technology Co., Ltd..
What is the FDA product code for LumiCera?
The FDA product code for LumiCera is EBF.
Other Devices by Hangzhou SHINING3D Dental Technology Co., Ltd.
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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.