ResiCem EX
K-Number: K251470 · 2025-07-11
ApplicantShofu Dental Corporation
Decision Date2025-07-11
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
ResiCem EX is a medical device manufactured by Shofu Dental Corporation. It received FDA 510(k) clearance on 2025-07-11 under approval number K251470. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ResiCem EX?
ResiCem EX is a medical device that received FDA 510(k) clearance on 2025-07-11. It is manufactured by Shofu Dental Corporation. The 510(k) number is K251470.
When was ResiCem EX approved by the FDA?
ResiCem EX received FDA 510(k) clearance on 2025-07-11, under approval number K251470.
What company makes ResiCem EX?
ResiCem EX is manufactured by Shofu Dental Corporation.
What is the FDA product code for ResiCem EX?
The FDA product code for ResiCem EX is EMA.
Other Devices by Shofu Dental Corporation
Related Devices (Code: EMA)
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.