ZIRKONZAHN SRL

FDA Device Registration & Listing · Gais Bolzano, IT · Registration 3005904906

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005904906
FEI Number
3005904906
Entity Name
ZIRKONZAHN SRL
City/State/Country
Gais Bolzano, IT
Establishment Address
VIA AN DER AHR 7, Gais Bolzano 39030, IT
Establishment Type(s)
Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
ZIRKONZAHN SRL (Owner Number: 9089299)
Owner / Operator Contact Address
VIA AN DER AHR 7, --, Gais, IT-BZ 39030, IT
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K190518
PMA Number
N/A

All Registered Proprietary Names

ICE Prettau Aquarell ICE Zirkon ICE Zirkon Stains Color Liquids SY1620 ZIRKONZAHN.Implant-Planner Practice SY1600 ZIRKONZAHN.Implant-Planner SY1670 ZIRKONZAHN.Implant-Planner Practice incl. Bone & Tooth Segmentation SY1660 ZIRKONZAHN.Implant-Planner incl. Bone & Tooth Segmentation ICE Transluzent Plus

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EIH Powder, Porcelain Dental Class 2 872.6660 2006-07-20
EGD Wax, Dental, Intraoral Dental Class 1 872.6890 2026-05-12
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2021-09-13
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2021-05-04
MQC Mouthguard, Prescription Unknown Class U N/A 2021-05-04
EBG Crown And Bridge, Temporary, Resin Dental Class 2 872.3770 2021-05-04
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2026-05-12
EBG Crown And Bridge, Temporary, Resin Dental Class 2 872.3770 2018-07-16
POW Crown And Bridge, Long-Term Temporary, Resin Dental Class 2 872.3770 2018-07-16
EIH Powder, Porcelain Dental Class 2 872.6660 2014-12-06
JAC System, X-Ray, Film Marking, Radiographic Radiology Class 1 892.1640 2026-05-12
EKO Denture Preformed (Partially Prefabricated Denture) Dental Class 2 872.3600 2026-05-12
EBH Material, Impression Tray, Resin Dental Class 1 872.3670 2026-05-12
EIH Powder, Porcelain Dental Class 2 872.6660 2019-04-29
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2018-06-28
ELM Denture, Plastic, Teeth Dental Class 2 872.3590 2023-09-25
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2023-09-25
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2017-10-27
EIH Powder, Porcelain Dental Class 2 872.6660 2023-02-09
EJH Alloy, Metal, Base Dental Class 2 872.3710 2015-12-22
EIH Powder, Porcelain Dental Class 2 872.6660 2019-11-29

Official Correspondent

JULIAN STEGER

US Agent Details

Julian Steger Business: Zirkonzahn USA Email: julian.steger@zirkonzahn.com Phone: (800) 9898931

Related Public Records

Same Entity

ZIRKONZAHN SRL
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K143656 H.C. Starck Ceramics GmbH StarCeram® Z-Nature, StarCeram® Z-Smile 2015-07-09
K080013 Agfa Healthcare Corporation REGISTRATION AND FUSION 2008-01-17
K042221 Barco NV Barcoview CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM 2004-12-30
K092915 Cedara Software Corp. CEDARA WEBACCESS, MODEL: 2.4 2010-06-23
K961871 Siemens Medical Solutions USA, Inc. FLOUROSPOT T.O.P. 1996-07-31

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0017-2017 Ivoclar Vivadent, Inc. 2
Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain
Z-0018-2017 Ivoclar Vivadent, Inc. 2
Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain
Z-0019-2017 Ivoclar Vivadent, Inc. 2
Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain
Z-0020-2017 Ivoclar Vivadent, Inc. 2
Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For coloring dental porcelain
Z-0021-2017 Ivoclar Vivadent, Inc. 2
Zenostar MT Color A1 60ml, art. no. 681050, Product Usage: For coloring dental porcelain

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005904906. Last updated year: 2026. Please use registration number 3005904906 when referencing this establishment in official correspondence.
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