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FDA 510(k)

VIRTUAL

K-Number: K060891 · 2006-07-17

ApplicantIvoclar Vivadent, Inc.
Decision Date2006-07-17
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VIRTUAL is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar Vivadent, Inc.. It received FDA 510(k) clearance on 2006-07-17 under 510(k) number K060891. 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 VIRTUAL?

VIRTUAL is a medical device that received FDA 510(k) clearance on 2006-07-17. The listed applicant is Ivoclar Vivadent, Inc.. The 510(k) number is K060891.

When did VIRTUAL receive FDA 510(k) clearance?

VIRTUAL received FDA 510(k) clearance on 2006-07-17, under 510(k) number K060891.

Who is the listed applicant for VIRTUAL?

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

What is the FDA product code for VIRTUAL?

The FDA product code for VIRTUAL is ELW.

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Related PubMed Literature

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.

PMID: 35460900Summary of the FDA virtual public workshop on spinal device clinical review held on September 17, 2021.The spine journal : official journal of the North American Spine Society ()

Other records listing Ivoclar Vivadent, Inc. as applicant

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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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