Dura-Crown
K-Number: K261356 · 2026-04-27
Decision Date2026-04-27
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Dura-Crown is a medical device manufactured by Hangzhou SHINING3D Dental Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-04-27 under approval number K261356. 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 Dura-Crown?
Dura-Crown is a medical device that received FDA 510(k) clearance on 2026-04-27. It is manufactured by Hangzhou SHINING3D Dental Technology Co., Ltd.. The 510(k) number is K261356.
When was Dura-Crown approved by the FDA?
Dura-Crown received FDA 510(k) clearance on 2026-04-27, under approval number K261356.
What company makes Dura-Crown?
Dura-Crown is manufactured by Hangzhou SHINING3D Dental Technology Co., Ltd..
What is the FDA product code for Dura-Crown?
The FDA product code for Dura-Crown 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.