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FDA 510(k)

PALFIQUE ESTELITE LV

K-Number: K002863 · 2001-01-04

ApplicantTokuyama America, Inc.
Decision Date2001-01-04
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PALFIQUE ESTELITE LV is the device name listed in this FDA 510(k) record. The listed applicant is Tokuyama America, Inc.. It received FDA 510(k) clearance on 2001-01-04 under 510(k) number K002863. 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 PALFIQUE ESTELITE LV?

PALFIQUE ESTELITE LV is a medical device that received FDA 510(k) clearance on 2001-01-04. The listed applicant is Tokuyama America, Inc.. The 510(k) number is K002863.

When did PALFIQUE ESTELITE LV receive FDA 510(k) clearance?

PALFIQUE ESTELITE LV received FDA 510(k) clearance on 2001-01-04, under 510(k) number K002863.

Who is the listed applicant for PALFIQUE ESTELITE LV?

The FDA 510(k) record lists Tokuyama America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PALFIQUE ESTELITE LV?

The FDA product code for PALFIQUE ESTELITE LV is EBF.

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Other records listing Tokuyama America, Inc. 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.

K022641TOKUYAMA REBASE IIK011854TOKUYAMA M-BONDK011685BISTITE II DCK010267PALFIQUE ESTELITE LV CLEARK993917TOKUYAMA ONE-UP-BOND FK991711BISTITE II SC

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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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