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FDA 510(k)

OBSIDIAN CERAMIC BLOCKS

K-Number: K100781 · 2010-06-21

ApplicantPrismatik Dentalcraft, Inc.
Decision Date2010-06-21
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OBSIDIAN CERAMIC BLOCKS is the device name listed in this FDA 510(k) record. The listed applicant is Prismatik Dentalcraft, Inc.. It received FDA 510(k) clearance on 2010-06-21 under 510(k) number K100781. 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 OBSIDIAN CERAMIC BLOCKS?

OBSIDIAN CERAMIC BLOCKS is a medical device that received FDA 510(k) clearance on 2010-06-21. The listed applicant is Prismatik Dentalcraft, Inc.. The 510(k) number is K100781.

When did OBSIDIAN CERAMIC BLOCKS receive FDA 510(k) clearance?

OBSIDIAN CERAMIC BLOCKS received FDA 510(k) clearance on 2010-06-21, under 510(k) number K100781.

Who is the listed applicant for OBSIDIAN CERAMIC BLOCKS?

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

What is the FDA product code for OBSIDIAN CERAMIC BLOCKS?

The FDA product code for OBSIDIAN CERAMIC BLOCKS is EIH.

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Other records listing Prismatik Dentalcraft, 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.

K261802Glidewell™ Denture Base ResinK262239Obsidian® Press Over ZirconiaK254283BruxZir® Shaded 16 PLUSK252582Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant SystemsK252446BruxZir® NOWK250302Flexible Partial Resin

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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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