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FDA 510(k)

LUTE; CORE

K-Number: K011517 · 2001-07-10

ApplicantFirst Scientific Limited
Decision Date2001-07-10
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LUTE; CORE 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 2001-07-10 under 510(k) number K011517. 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; CORE?

LUTE; CORE is a medical device that received FDA 510(k) clearance on 2001-07-10. The listed applicant is First Scientific Limited. The 510(k) number is K011517.

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

LUTE; CORE received FDA 510(k) clearance on 2001-07-10, under 510(k) number K011517.

Who is the listed applicant for LUTE; CORE?

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; CORE?

The FDA product code for LUTE; CORE 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-XK011295RESTORE-PF VIC; RESTORE-PF VLC CAPSULEK011309LUTE VLC; CORE VLC

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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