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FDA 510(k)

PULPDENT MICRO-HYBRID COMPOSITE

K-Number: K090391 · 2009-05-11

ApplicantPulpdent Corporation
Decision Date2009-05-11
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PULPDENT MICRO-HYBRID COMPOSITE is the device name listed in this FDA 510(k) record. The listed applicant is Pulpdent Corporation. It received FDA 510(k) clearance on 2009-05-11 under 510(k) number K090391. 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 MICRO-HYBRID COMPOSITE?

PULPDENT MICRO-HYBRID COMPOSITE is a medical device that received FDA 510(k) clearance on 2009-05-11. The listed applicant is Pulpdent Corporation. The 510(k) number is K090391.

When did PULPDENT MICRO-HYBRID COMPOSITE receive FDA 510(k) clearance?

PULPDENT MICRO-HYBRID COMPOSITE received FDA 510(k) clearance on 2009-05-11, under 510(k) number K090391.

Who is the listed applicant for PULPDENT MICRO-HYBRID COMPOSITE?

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 MICRO-HYBRID COMPOSITE?

The FDA product code for PULPDENT MICRO-HYBRID COMPOSITE is EBF.

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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 MCPK153249Pulpdent Solo Flowable Composite with MCPK130223RMGI FILLK123265RMGI LOW VISCOSITY

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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.

K262982Core·it DualSpident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261246SRGC-06GC America, Inc.

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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