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FDA 510(k)

QUIXX POSTERIOR RESTORATIVE

K-Number: K040144 · 2004-04-01

ApplicantDentsply International
Decision Date2004-04-01
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

QUIXX POSTERIOR RESTORATIVE is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply International. It received FDA 510(k) clearance on 2004-04-01 under 510(k) number K040144. 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 QUIXX POSTERIOR RESTORATIVE?

QUIXX POSTERIOR RESTORATIVE is a medical device that received FDA 510(k) clearance on 2004-04-01. The listed applicant is Dentsply International. The 510(k) number is K040144.

When did QUIXX POSTERIOR RESTORATIVE receive FDA 510(k) clearance?

QUIXX POSTERIOR RESTORATIVE received FDA 510(k) clearance on 2004-04-01, under 510(k) number K040144.

Who is the listed applicant for QUIXX POSTERIOR RESTORATIVE?

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

What is the FDA product code for QUIXX POSTERIOR RESTORATIVE?

The FDA product code for QUIXX POSTERIOR RESTORATIVE is EBF.

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Other records listing Dentsply International 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.

K122268ANGLED XIVE MP ABUTMENT, ANGLED ANKYLOSK061580ECLIPSE WAX REMOVERK060837IN-OVATION CK053368INTERPROXIMAL REDUCTION SYSTEMK052370CP BRACKET SYSTEMK052097CERAM X UNIVERSAL MANO-CERAMIC RESTORATIVE

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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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