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FDA 510(k)

FLEXITIME BITE

K-Number: K082591 · 2008-12-05

ApplicantHeraeus Kulzer, Inc., Dental Products Division
Decision Date2008-12-05
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FLEXITIME BITE is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Kulzer, Inc., Dental Products Division. It received FDA 510(k) clearance on 2008-12-05 under 510(k) number K082591. 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 FLEXITIME BITE?

FLEXITIME BITE is a medical device that received FDA 510(k) clearance on 2008-12-05. The listed applicant is Heraeus Kulzer, Inc., Dental Products Division. The 510(k) number is K082591.

When did FLEXITIME BITE receive FDA 510(k) clearance?

FLEXITIME BITE received FDA 510(k) clearance on 2008-12-05, under 510(k) number K082591.

Who is the listed applicant for FLEXITIME BITE?

The FDA 510(k) record lists Heraeus Kulzer, Inc., Dental Products Division as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLEXITIME BITE?

The FDA product code for FLEXITIME BITE is ELW.

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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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