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FDA 510(k)

ORTHO VLC; ORTHO VLC CAPSULE

K-Number: K011521 · 2001-08-01

ApplicantFirst Scientific Limited
Decision Date2001-08-01
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORTHO VLC; ORTHO VLC CAPSULE 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 2001-08-01 under 510(k) number K011521. The device is classified under product code DYH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHO VLC; ORTHO VLC CAPSULE?

ORTHO VLC; ORTHO VLC CAPSULE is a medical device that received FDA 510(k) clearance on 2001-08-01. The listed applicant is First Scientific Limited. The 510(k) number is K011521.

When did ORTHO VLC; ORTHO VLC CAPSULE receive FDA 510(k) clearance?

ORTHO VLC; ORTHO VLC CAPSULE received FDA 510(k) clearance on 2001-08-01, under 510(k) number K011521.

Who is the listed applicant for ORTHO VLC; ORTHO VLC CAPSULE?

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 ORTHO VLC; ORTHO VLC CAPSULE?

The FDA product code for ORTHO VLC; ORTHO VLC CAPSULE is DYH.

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.

K011520RESTORE-XK011517LUTE; COREK011295RESTORE-PF VIC; RESTORE-PF VLC CAPSULEK011309LUTE VLC; CORE VLC

Related Devices (Code: DYH)

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.

K261129OrthoFitSpident Co., Ltd.K261840BracePaste Prime PlusAmerican OrthodonticsK250015Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree AdhesiveOrmco CorporationK242537BracePaste Fluoride SealantAmerican Orthodontics Corp.K2340433M™ Transbond™ Orthodontic Adhesive3M Unitek Orthodontic ProductsK231817AlignerFlow LCVoco GmbH

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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