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FDA 510(k)

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

K-Number: K070699 · 2007-06-29

ApplicantPentron Ceramics, Inc.
Decision Date2007-06-29
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AVANTE Z; PELLET, PRESSABLE STAIN, ADD-ON PORCELAIN, PORCELAIN 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 2007-06-29 under 510(k) number K070699. 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; PELLET, PRESSABLE STAIN, ADD-ON PORCELAIN, PORCELAIN?

AVANTE Z; PELLET, PRESSABLE STAIN, ADD-ON PORCELAIN, PORCELAIN is a medical device that received FDA 510(k) clearance on 2007-06-29. The listed applicant is Pentron Ceramics, Inc.. The 510(k) number is K070699.

When did AVANTE Z; PELLET, PRESSABLE STAIN, ADD-ON PORCELAIN, PORCELAIN receive FDA 510(k) clearance?

AVANTE Z; PELLET, PRESSABLE STAIN, ADD-ON PORCELAIN, PORCELAIN received FDA 510(k) clearance on 2007-06-29, under 510(k) number K070699.

Who is the listed applicant for AVANTE Z; PELLET, PRESSABLE STAIN, ADD-ON PORCELAIN, PORCELAIN?

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; PELLET, PRESSABLE STAIN, ADD-ON PORCELAIN, PORCELAIN?

The FDA product code for AVANTE Z; PELLET, PRESSABLE STAIN, ADD-ON PORCELAIN, PORCELAIN is EIH.

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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.

K081749AVANTE Z ZIRCONIA (AS)3 BLOCKS

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

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