Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)
K-Number: K253053 · 2025-09-23
Decision Date2025-09-23
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) is a medical device manufactured by Hangzhou SHINING3D Dental Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-09-23 under approval number K253053. 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 (CB21-A1/CB21-A2/CB21-A3/CB21-B1)?
Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) is a medical device that received FDA 510(k) clearance on 2025-09-23. It is manufactured by Hangzhou SHINING3D Dental Technology Co., Ltd.. The 510(k) number is K253053.
When was Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) approved by the FDA?
Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) received FDA 510(k) clearance on 2025-09-23, under approval number K253053.
What company makes Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)?
Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) is manufactured by Hangzhou SHINING3D Dental Technology Co., Ltd..
What is the FDA product code for Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)?
The FDA product code for Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) 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.