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FDA 510(k)

CUTTERSIL ACTIVATOR UNIVERSAL PLUS

K-Number: K080338 · 2008-04-21

ApplicantHeraeus Kulzer,GmbH
Decision Date2008-04-21
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CUTTERSIL ACTIVATOR UNIVERSAL PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Kulzer,GmbH. It received FDA 510(k) clearance on 2008-04-21 under 510(k) number K080338. 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 CUTTERSIL ACTIVATOR UNIVERSAL PLUS?

CUTTERSIL ACTIVATOR UNIVERSAL PLUS is a medical device that received FDA 510(k) clearance on 2008-04-21. The listed applicant is Heraeus Kulzer,GmbH. The 510(k) number is K080338.

When did CUTTERSIL ACTIVATOR UNIVERSAL PLUS receive FDA 510(k) clearance?

CUTTERSIL ACTIVATOR UNIVERSAL PLUS received FDA 510(k) clearance on 2008-04-21, under 510(k) number K080338.

Who is the listed applicant for CUTTERSIL ACTIVATOR UNIVERSAL PLUS?

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

What is the FDA product code for CUTTERSIL ACTIVATOR UNIVERSAL PLUS?

The FDA product code for CUTTERSIL ACTIVATOR UNIVERSAL PLUS is ELW.

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Other records listing Heraeus Kulzer,GmbH 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.

K083652IBOND TOTAL ETCHK073554NEUNK062515RETENTION FLOW OPAQUEK050085OSTEOPAL VK050854PALACOS LV+GK050855PALAMED G

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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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