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FDA 510(k)

CREATION CP-ZI PORCELAIN

K-Number: K070114 · 2007-03-01

ApplicantJensen Industries, Inc.
Decision Date2007-03-01
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CREATION CP-ZI PORCELAIN 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 2007-03-01 under 510(k) number K070114. 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 CREATION CP-ZI PORCELAIN?

CREATION CP-ZI PORCELAIN is a medical device that received FDA 510(k) clearance on 2007-03-01. The listed applicant is Jensen Industries, Inc.. The 510(k) number is K070114.

When did CREATION CP-ZI PORCELAIN receive FDA 510(k) clearance?

CREATION CP-ZI PORCELAIN received FDA 510(k) clearance on 2007-03-01, under 510(k) number K070114.

Who is the listed applicant for CREATION CP-ZI PORCELAIN?

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 CREATION CP-ZI PORCELAIN?

The FDA product code for CREATION CP-ZI PORCELAIN 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 SYSTEMK050838THE LF-P CERAMIC SYSTEMK043201WILLI 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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