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FDA 510(k)

THE LF-P CERAMIC SYSTEM

K-Number: K050838 · 2005-05-04

ApplicantJensen Industries, Inc.
Decision Date2005-05-04
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

THE LF-P CERAMIC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Jensen Industries, Inc.. It received FDA 510(k) clearance on 2005-05-04 under 510(k) number K050838. 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 THE LF-P CERAMIC SYSTEM?

THE LF-P CERAMIC SYSTEM is a medical device that received FDA 510(k) clearance on 2005-05-04. The listed applicant is Jensen Industries, Inc.. The 510(k) number is K050838.

When did THE LF-P CERAMIC SYSTEM receive FDA 510(k) clearance?

THE LF-P CERAMIC SYSTEM received FDA 510(k) clearance on 2005-05-04, under 510(k) number K050838.

Who is the listed applicant for THE LF-P CERAMIC SYSTEM?

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

What is the FDA product code for THE LF-P CERAMIC SYSTEM?

The FDA product code for THE LF-P CERAMIC SYSTEM is EIH.

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Other records listing Jensen Industries, Inc. 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.

K183408Jensen Shade Effect LiquidsK112806JENSEN ZIRCONIAK111743THE INSYNC CERAMIC SYSTEMK070114CREATION CP-ZI PORCELAINK043201WILLI GELLER CREATION ZI PORCELAINK043221WILLI GELLER CREATION CP PORCELAIN

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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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