DIAFIL & DIAFIL Capsule
K-Number: K192510 · 2020-03-20
ApplicantDiaDent Group International
Decision Date2020-03-20
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
DIAFIL & DIAFIL Capsule is a medical device manufactured by DiaDent Group International. It received FDA 510(k) clearance on 2020-03-20 under approval number K192510. 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 DIAFIL & DIAFIL Capsule?
DIAFIL & DIAFIL Capsule is a medical device that received FDA 510(k) clearance on 2020-03-20. It is manufactured by DiaDent Group International. The 510(k) number is K192510.
When was DIAFIL & DIAFIL Capsule approved by the FDA?
DIAFIL & DIAFIL Capsule received FDA 510(k) clearance on 2020-03-20, under approval number K192510.
What company makes DIAFIL & DIAFIL Capsule?
DIAFIL & DIAFIL Capsule is manufactured by DiaDent Group International.
What is the FDA product code for DIAFIL & DIAFIL Capsule?
The FDA product code for DIAFIL & DIAFIL Capsule is EBF.
Other Devices by DiaDent Group International
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.