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FDA 510(k)

AVANTE Z ZIRCONIA (AS)3 BLOCKS

K-Number: K081749 · 2008-09-30

ApplicantPentron Ceramics, Inc.
Decision Date2008-09-30
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AVANTE Z ZIRCONIA (AS)3 BLOCKS is the device name listed in this FDA 510(k) record. The listed applicant is Pentron Ceramics, Inc.. It received FDA 510(k) clearance on 2008-09-30 under 510(k) number K081749. 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 AVANTE Z ZIRCONIA (AS)3 BLOCKS?

AVANTE Z ZIRCONIA (AS)3 BLOCKS is a medical device that received FDA 510(k) clearance on 2008-09-30. The listed applicant is Pentron Ceramics, Inc.. The 510(k) number is K081749.

When did AVANTE Z ZIRCONIA (AS)3 BLOCKS receive FDA 510(k) clearance?

AVANTE Z ZIRCONIA (AS)3 BLOCKS received FDA 510(k) clearance on 2008-09-30, under 510(k) number K081749.

Who is the listed applicant for AVANTE Z ZIRCONIA (AS)3 BLOCKS?

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

What is the FDA product code for AVANTE Z ZIRCONIA (AS)3 BLOCKS?

The FDA product code for AVANTE Z ZIRCONIA (AS)3 BLOCKS is EIH.

Related Clinical Trials

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.

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Other records listing Pentron Ceramics, 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.

K070699AVANTE Z; PELLET, PRESSABLE STAIN, ADD-ON PORCELAIN, PORCELAIN

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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