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FDA 510(k)

POSITION PENTA, POSITION PENTA QUICK

K-Number: K974231 · 1998-01-29

ApplicantEspe GmbH & Co. Kg.
Decision Date1998-01-29
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

POSITION PENTA, POSITION PENTA QUICK is the device name listed in this FDA 510(k) record. The listed applicant is Espe GmbH & Co. Kg.. It received FDA 510(k) clearance on 1998-01-29 under 510(k) number K974231. 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 POSITION PENTA, POSITION PENTA QUICK?

POSITION PENTA, POSITION PENTA QUICK is a medical device that received FDA 510(k) clearance on 1998-01-29. The listed applicant is Espe GmbH & Co. Kg.. The 510(k) number is K974231.

When did POSITION PENTA, POSITION PENTA QUICK receive FDA 510(k) clearance?

POSITION PENTA, POSITION PENTA QUICK received FDA 510(k) clearance on 1998-01-29, under 510(k) number K974231.

Who is the listed applicant for POSITION PENTA, POSITION PENTA QUICK?

The FDA 510(k) record lists Espe GmbH & Co. Kg. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POSITION PENTA, POSITION PENTA QUICK?

The FDA product code for POSITION PENTA, POSITION PENTA QUICK is ELW.

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Other records listing Espe GmbH & Co. Kg. 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.

K973513SINFONY DENTIN, OPAQUE-DENTIN, ENAMEL, ENAMEL MODIFIER, TRANSPARENT OPAL,SINFONY MAGIC MODIFIERS, SINFONY OPAQUERK973262KETAC-FIL APLICAP PLUSK972892CAVIT-LCK963735COJET SYSTEMK963737HYCEM APLICAPK962428EBS (ESPE BONDING SYSTEM)

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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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