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FDA 510(k)

ELEGANT

K-Number: K091826 · 2009-09-25

Applicant3M Espe AG Dental Products
Decision Date2009-09-25
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ELEGANT is the device name listed in this FDA 510(k) record. The listed applicant is 3M Espe AG Dental Products. It received FDA 510(k) clearance on 2009-09-25 under 510(k) number K091826. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELEGANT?

ELEGANT is a medical device that received FDA 510(k) clearance on 2009-09-25. The listed applicant is 3M Espe AG Dental Products. The 510(k) number is K091826.

When did ELEGANT receive FDA 510(k) clearance?

ELEGANT received FDA 510(k) clearance on 2009-09-25, under 510(k) number K091826.

Who is the listed applicant for ELEGANT?

The FDA 510(k) record lists 3M Espe AG Dental Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELEGANT?

The FDA product code for ELEGANT is EIH.

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Other records listing 3M Espe AG Dental Products 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.

K100908UNICEM HMK100756MALTAK094007UNICEMK093721COSP2K090718BELLUS SHADING KITK080514PECD-01 AND PECD QUICK-01

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Related Devices (Code: EIH)

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.

K262074Any-ZircosMediclus Co., Ltd.K262239Obsidian® Press Over ZirconiaPrismatik Dentalcraft, Inc.K261046Dental Zirconia Blank & Coloring LiquidHunan Qinghao Puzhong Technology Co., Ltd.K262195Dandy Ceramic Stain and GlazeZima International Inc., dba DandyK260918Zolid LunarisAmann Girrbach AGK260859Rosetta SM, Rosetta SPHass Corp.

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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