Opallis, Opallis Flow
K-Number: K201707 · 2020-12-22
ApplicantDentscare Ltda
Decision Date2020-12-22
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Opallis, Opallis Flow is a medical device manufactured by Dentscare Ltda. It received FDA 510(k) clearance on 2020-12-22 under approval number K201707. 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 Opallis, Opallis Flow?
Opallis, Opallis Flow is a medical device that received FDA 510(k) clearance on 2020-12-22. It is manufactured by Dentscare Ltda. The 510(k) number is K201707.
When was Opallis, Opallis Flow approved by the FDA?
Opallis, Opallis Flow received FDA 510(k) clearance on 2020-12-22, under approval number K201707.
What company makes Opallis, Opallis Flow?
Opallis, Opallis Flow is manufactured by Dentscare Ltda.
What is the FDA product code for Opallis, Opallis Flow?
The FDA product code for Opallis, Opallis Flow is EBF.
Other Devices by Dentscare Ltda
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.