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FDA 510(k)

TIZIAN CERAMIC, FLOW, PLATE, FIX & ZR BLANKS

K-Number: K071010 · 2007-08-24

ApplicantSchutz-Dental GmbH
Decision Date2007-08-24
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TIZIAN CERAMIC, FLOW, PLATE, FIX & ZR BLANKS is the device name listed in this FDA 510(k) record. The listed applicant is Schutz-Dental GmbH. It received FDA 510(k) clearance on 2007-08-24 under 510(k) number K071010. 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 TIZIAN CERAMIC, FLOW, PLATE, FIX & ZR BLANKS?

TIZIAN CERAMIC, FLOW, PLATE, FIX & ZR BLANKS is a medical device that received FDA 510(k) clearance on 2007-08-24. The listed applicant is Schutz-Dental GmbH. The 510(k) number is K071010.

When did TIZIAN CERAMIC, FLOW, PLATE, FIX & ZR BLANKS receive FDA 510(k) clearance?

TIZIAN CERAMIC, FLOW, PLATE, FIX & ZR BLANKS received FDA 510(k) clearance on 2007-08-24, under 510(k) number K071010.

Who is the listed applicant for TIZIAN CERAMIC, FLOW, PLATE, FIX & ZR BLANKS?

The FDA 510(k) record lists Schutz-Dental GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TIZIAN CERAMIC, FLOW, PLATE, FIX & ZR BLANKS?

The FDA product code for TIZIAN CERAMIC, FLOW, PLATE, FIX & ZR BLANKS is EIH.

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Other records listing Schutz-Dental GmbH 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.

K151399Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq FlowK052073FUTURAPRESS LT, N AND HP, FUTURAJET, FUTURASELF, FUTURAGEN AND FUTURACRYL 2000K052189REVENEER CERAMIC REPAIR SYSTEMK051050SEBOND PINK LIGHT 5G, SEBOND PINK DARK 5G, SEBOND SMART 5ML, SEBOND GRIP 3G, MODELS 644090, 644091, 640066, 644092

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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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