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FDA 510(k)

RESTORE-X

K-Number: K011520 · 2001-07-23

ApplicantFirst Scientific Limited
Decision Date2001-07-23
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RESTORE-X 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 2001-07-23 under 510(k) number K011520. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESTORE-X?

RESTORE-X is a medical device that received FDA 510(k) clearance on 2001-07-23. The listed applicant is First Scientific Limited. The 510(k) number is K011520.

When did RESTORE-X receive FDA 510(k) clearance?

RESTORE-X received FDA 510(k) clearance on 2001-07-23, under 510(k) number K011520.

Who is the listed applicant for RESTORE-X?

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 RESTORE-X?

The FDA product code for RESTORE-X is EMA.

Related Clinical Trials

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.

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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 CAPSULEK011517LUTE; COREK011295RESTORE-PF VIC; RESTORE-PF VLC CAPSULEK011309LUTE VLC; CORE VLC

Related Devices (Code: EMA)

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.

K262983EsTemp ImplantSpident Co., Ltd.K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, 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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