Dura-Arch
K-Number: K261261 · 2026-04-17
Decision Date2026-04-17
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Dura-Arch is a medical device manufactured by Hangzhou SHINING3D Dental Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-04-17 under approval number K261261. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Dura-Arch?
Dura-Arch is a medical device that received FDA 510(k) clearance on 2026-04-17. It is manufactured by Hangzhou SHINING3D Dental Technology Co., Ltd.. The 510(k) number is K261261.
When was Dura-Arch approved by the FDA?
Dura-Arch received FDA 510(k) clearance on 2026-04-17, under approval number K261261.
What company makes Dura-Arch?
Dura-Arch is manufactured by Hangzhou SHINING3D Dental Technology Co., Ltd..
What is the FDA product code for Dura-Arch?
The FDA product code for Dura-Arch is EBG.
Other Devices by Hangzhou SHINING3D Dental Technology Co., Ltd.
Related Devices (Code: EBG)
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.