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FDA 510(k)

IPS Style Ceram, IPS Style Ceram One, IPS Style Press

K-Number: K152103 · 2016-05-20

ApplicantIvoclar Vivadent, AG
Decision Date2016-05-20
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IPS Style Ceram, IPS Style Ceram One, IPS Style Press is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar Vivadent, AG. It received FDA 510(k) clearance on 2016-05-20 under 510(k) number K152103. 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 IPS Style Ceram, IPS Style Ceram One, IPS Style Press?

IPS Style Ceram, IPS Style Ceram One, IPS Style Press is a medical device that received FDA 510(k) clearance on 2016-05-20. The listed applicant is Ivoclar Vivadent, AG. The 510(k) number is K152103.

When did IPS Style Ceram, IPS Style Ceram One, IPS Style Press receive FDA 510(k) clearance?

IPS Style Ceram, IPS Style Ceram One, IPS Style Press received FDA 510(k) clearance on 2016-05-20, under 510(k) number K152103.

Who is the listed applicant for IPS Style Ceram, IPS Style Ceram One, IPS Style Press?

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

What is the FDA product code for IPS Style Ceram, IPS Style Ceram One, IPS Style Press?

The FDA product code for IPS Style Ceram, IPS Style Ceram One, IPS Style Press is EIH.

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NCT06898411Clinical Evaluation on the Longevity of Glass Ceramic Based Single Tooth RestorationsCOMPLETEDNCT07622043Effectiveness of Two Different Desensitizing Dental VarnishesRECRUITING

Other records listing Ivoclar Vivadent, AG as applicant

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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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