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FDA 510(k)

ALGI-BAND

K-Number: K951237 · 1995-04-10

ApplicantHealth-Dent Intl., Inc.
Decision Date1995-04-10
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ALGI-BAND is the device name listed in this FDA 510(k) record. The listed applicant is Health-Dent Intl., Inc.. It received FDA 510(k) clearance on 1995-04-10 under 510(k) number K951237. 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 ALGI-BAND?

ALGI-BAND is a medical device that received FDA 510(k) clearance on 1995-04-10. The listed applicant is Health-Dent Intl., Inc.. The 510(k) number is K951237.

When did ALGI-BAND receive FDA 510(k) clearance?

ALGI-BAND received FDA 510(k) clearance on 1995-04-10, under 510(k) number K951237.

Who is the listed applicant for ALGI-BAND?

The FDA 510(k) record lists Health-Dent Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALGI-BAND?

The FDA product code for ALGI-BAND is ELW.

Other records listing Health-Dent Intl., 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.

K972198DENT-TEMP ACRYLICK953405HEMA-BENZK951220HEMA-GLUK951381VILAK951380VILA PCK951235GIROC

View all 8 devices →

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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