TempFIT Temporary Crown and Bridge Resin
K-Number: K251271 · 2025-06-23
Decision Date2025-06-23
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
TempFIT Temporary Crown and Bridge Resin is a medical device manufactured by Rizhao Huge Biomaterials Company, Ltd.. It received FDA 510(k) clearance on 2025-06-23 under approval number K251271. 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 TempFIT Temporary Crown and Bridge Resin?
TempFIT Temporary Crown and Bridge Resin is a medical device that received FDA 510(k) clearance on 2025-06-23. It is manufactured by Rizhao Huge Biomaterials Company, Ltd.. The 510(k) number is K251271.
When was TempFIT Temporary Crown and Bridge Resin approved by the FDA?
TempFIT Temporary Crown and Bridge Resin received FDA 510(k) clearance on 2025-06-23, under approval number K251271.
What company makes TempFIT Temporary Crown and Bridge Resin?
TempFIT Temporary Crown and Bridge Resin is manufactured by Rizhao Huge Biomaterials Company, Ltd..
What is the FDA product code for TempFIT Temporary Crown and Bridge Resin?
The FDA product code for TempFIT Temporary Crown and Bridge Resin is EBG.
Related Clinical Trials
Other Devices by Rizhao Huge Biomaterials Company, 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.