BRILLIANT Crios
K-Number: K181500 · 2018-08-15
ApplicantColtene/Whaledent AG
Decision Date2018-08-15
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
BRILLIANT Crios is a medical device manufactured by Coltene/Whaledent AG. It received FDA 510(k) clearance on 2018-08-15 under approval number K181500. 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 BRILLIANT Crios?
BRILLIANT Crios is a medical device that received FDA 510(k) clearance on 2018-08-15. It is manufactured by Coltene/Whaledent AG. The 510(k) number is K181500.
When was BRILLIANT Crios approved by the FDA?
BRILLIANT Crios received FDA 510(k) clearance on 2018-08-15, under approval number K181500.
What company makes BRILLIANT Crios?
BRILLIANT Crios is manufactured by Coltene/Whaledent AG.
What is the FDA product code for BRILLIANT Crios?
The FDA product code for BRILLIANT Crios is EBF.
Other Devices by Coltene/Whaledent AG
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.