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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 the device name listed in this FDA 510(k) record. The listed applicant is Pulpdent Corporation. It received FDA 510(k) clearance on 2016-04-01 under 510(k) 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. The listed applicant is Pulpdent Corporation. The 510(k) number is K153249.

When did Pulpdent Solo Flowable Composite with MCP receive FDA 510(k) clearance?

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

Who is the listed applicant for Pulpdent Solo Flowable Composite with MCP?

The FDA 510(k) record lists Pulpdent Corporation as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Pulpdent Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K210045ACTIVA PRESTO PACKK173020OBA-MCP, Orthodontic Bracket Adhesive with MCPK172169Pulpdent (Activa) Pit and Fissure Sealant with MCP

Related Devices (Code: EBF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K261246SRGC-06GC America, Inc.K261093DIAFILDiaDent Group InternationalK261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)DiaDent Group InternationalK260805Dual CoreVericom Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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