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FDA 510(k)

BLUGOO HD

K-Number: K071192 · 2007-06-22

ApplicantLancer Orthodontics, Inc.
Decision Date2007-06-22
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BLUGOO HD is the device name listed in this FDA 510(k) record. The listed applicant is Lancer Orthodontics, Inc.. It received FDA 510(k) clearance on 2007-06-22 under 510(k) number K071192. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLUGOO HD?

BLUGOO HD is a medical device that received FDA 510(k) clearance on 2007-06-22. The listed applicant is Lancer Orthodontics, Inc.. The 510(k) number is K071192.

When did BLUGOO HD receive FDA 510(k) clearance?

BLUGOO HD received FDA 510(k) clearance on 2007-06-22, under 510(k) number K071192.

Who is the listed applicant for BLUGOO HD?

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

What is the FDA product code for BLUGOO HD?

The FDA product code for BLUGOO HD is ELW.

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Other records listing Lancer Orthodontics, 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.

K122069STORM MINI SCREWK051552O.A.S.I. SYSTEMK991481PARAGONK904090ORTHODONTIC BONDING ADHESIVE CONTROLK904092LANCER ORIGINAL, SIERRA, GENERAL PURPOSEK904093BUCCAL TUBE, BUCCAL ATTACHMENT

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Related Devices (Code: ELW)

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.

K254152Dia-X Sil Light BodyDiaDent Group InternationalK254142Dia-X Sil Heavy BodyDiaDent Group InternationalK254112Dia-X Sil BiteDiaDent Group InternationalK253501Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327); Chroma Print Premium Fast Set - 454g (1lb) (052457); Chroma Print Premium Regular Set - 454g (1lb) (051460); Perfil Pro - 454g (1lb) (056213); Perfil Pro+ - 454g (1lb) (056121); Perfil Pro Chroma - 454g (1lb) (056122); Hydro Print Premium Fast Set - Multi Pack (056205); Hydro Print Premium Regular Set - Multi Pack (056208); Hydro Print Premium Fast Set - 9,07Kg (20lb) (056204);Vigodent Indústria E Comercio LtdaK250969JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFASTDent4you AGK241924Elastic Impression MaterialBeijing Okvd Biological Technology , Ltd.

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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