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FDA 510(k)

Pulpdent Solo Flowable Composite with MCP

K-Number: K153249 · 2016-04-01

ApplicantPulpdent Corporation
Decision Date2016-04-01
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Pulpdent Solo Flowable Composite with MCP is a medical device manufactured by Pulpdent Corporation. It received FDA 510(k) clearance on 2016-04-01 under approval number K153249. 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 Pulpdent Solo Flowable Composite with MCP?

Pulpdent Solo Flowable Composite with MCP is a medical device that received FDA 510(k) clearance on 2016-04-01. It is manufactured by Pulpdent Corporation. The 510(k) number is K153249.

When was Pulpdent Solo Flowable Composite with MCP approved by the FDA?

Pulpdent Solo Flowable Composite with MCP received FDA 510(k) clearance on 2016-04-01, under approval number K153249.

What company makes Pulpdent Solo Flowable Composite with MCP?

Pulpdent Solo Flowable Composite with MCP is manufactured by Pulpdent Corporation.

What is the FDA product code for Pulpdent Solo Flowable Composite with MCP?

The FDA product code for Pulpdent Solo Flowable Composite with MCP is EBF.

Related Clinical Trials

NCT07535086 Clinical Performance of Short Fiber Reinforced Flowable Versus Conventional Injectable Flowable Resin Composite Restorations in Class I Carious Cavities ACTIVE_NOT_RECRUITING

Other Devices by Pulpdent Corporation

K173020OBA-MCP, Orthodontic Bracket Adhesive with MCP K172169Pulpdent (Activa) Pit and Fissure Sealant with MCP K210045ACTIVA PRESTO PACK

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.

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