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FDA 510(k)

LUTE VLC; CORE VLC

K-Number: K011309 · 2001-06-22

ApplicantFirst Scientific Limited
Decision Date2001-06-22
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LUTE VLC; CORE VLC is the device name listed in this FDA 510(k) record. The listed applicant is First Scientific Limited. It received FDA 510(k) clearance on 2001-06-22 under 510(k) number K011309. 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 LUTE VLC; CORE VLC?

LUTE VLC; CORE VLC is a medical device that received FDA 510(k) clearance on 2001-06-22. The listed applicant is First Scientific Limited. The 510(k) number is K011309.

When did LUTE VLC; CORE VLC receive FDA 510(k) clearance?

LUTE VLC; CORE VLC received FDA 510(k) clearance on 2001-06-22, under 510(k) number K011309.

Who is the listed applicant for LUTE VLC; CORE VLC?

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

What is the FDA product code for LUTE VLC; CORE VLC?

The FDA product code for LUTE VLC; CORE VLC is EBF.

Other records listing First Scientific Limited 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.

K011521ORTHO VLC; ORTHO VLC CAPSULEK011520RESTORE-XK011517LUTE; COREK011295RESTORE-PF VIC; RESTORE-PF VLC CAPSULE

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

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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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