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FDA 510(k)

Rainbow LS Pressing

K-Number: K151846 · 2016-01-14

ApplicantGenoss
Decision Date2016-01-14
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Rainbow LS Pressing is the device name listed in this FDA 510(k) record. The listed applicant is Genoss. It received FDA 510(k) clearance on 2016-01-14 under 510(k) number K151846. 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 Rainbow LS Pressing?

Rainbow LS Pressing is a medical device that received FDA 510(k) clearance on 2016-01-14. The listed applicant is Genoss. The 510(k) number is K151846.

When did Rainbow LS Pressing receive FDA 510(k) clearance?

Rainbow LS Pressing received FDA 510(k) clearance on 2016-01-14, under 510(k) number K151846.

Who is the listed applicant for Rainbow LS Pressing?

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

What is the FDA product code for Rainbow LS Pressing?

The FDA product code for Rainbow LS Pressing is EIH.

Other records listing Genoss 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.

K242386BluemoonK222688The TrustK233885rainbow Paste Stain SEK232174rainbowTM Multi-Layer Block / bright 3-Layer / bright MonoK231480Bright MTA Sealer PlusK214086Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty

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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.

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.K253191DCMhotbond zirconDental Creativ Management GmbH

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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