CERAMAGE UP
K-Number: K162261 · 2017-01-11
ApplicantShofu Dental Corporation
Decision Date2017-01-11
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
CERAMAGE UP is a medical device manufactured by Shofu Dental Corporation. It received FDA 510(k) clearance on 2017-01-11 under approval number K162261. 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 CERAMAGE UP?
CERAMAGE UP is a medical device that received FDA 510(k) clearance on 2017-01-11. It is manufactured by Shofu Dental Corporation. The 510(k) number is K162261.
When was CERAMAGE UP approved by the FDA?
CERAMAGE UP received FDA 510(k) clearance on 2017-01-11, under approval number K162261.
What company makes CERAMAGE UP?
CERAMAGE UP is manufactured by Shofu Dental Corporation.
What is the FDA product code for CERAMAGE UP?
The FDA product code for CERAMAGE UP is EBF.
Other Devices by Shofu Dental Corporation
Related Devices (Code: EBF)
K163207Filtek One Bulk Fill Restorative3M Company
K162537CAD/CAMouflage Milling BlockPrismatik Dentalcraft, Inc.
K160049CharismaHeraeus Kulzer, LLC (Mitsui Chemicals Group)
K162257P1145 Dental RestorativeKerr Corporation
K151399Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq FlowSchutz Dental GmbH
K162107TPH Spectra+ Universal Composite RestorativeDentsply Sirona
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.