GlasIonomer FX ULTRA
K-Number: K222253 · 2022-09-22
ApplicantShofu Dental Corporation
Decision Date2022-09-22
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
GlasIonomer FX ULTRA is a medical device manufactured by Shofu Dental Corporation. It received FDA 510(k) clearance on 2022-09-22 under approval number K222253. 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 GlasIonomer FX ULTRA?
GlasIonomer FX ULTRA is a medical device that received FDA 510(k) clearance on 2022-09-22. It is manufactured by Shofu Dental Corporation. The 510(k) number is K222253.
When was GlasIonomer FX ULTRA approved by the FDA?
GlasIonomer FX ULTRA received FDA 510(k) clearance on 2022-09-22, under approval number K222253.
What company makes GlasIonomer FX ULTRA?
GlasIonomer FX ULTRA is manufactured by Shofu Dental Corporation.
What is the FDA product code for GlasIonomer FX ULTRA?
The FDA product code for GlasIonomer FX ULTRA 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.