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Zirkonzahn SRL: FDA-registered device maker in Gais Bolzano, Italy, 11 510(k) clearances

Name: Zirkonzahn SRL FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Zirkonzahn SRL is registered with the FDA (registration 3005904906) in Gais Bolzano, Italy. It lists 18 device types. The FDA files 11 510(k) clearances under its listings, the newest dated September 5, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3005904906
Address: Via An Der Ahr 7, Gais Bolzano, Italy, 39030
Owner or operator: ZIRKONZAHN SRL (9089299)
Roles: Contract manufacturer, Manufacturer
First device listed: July 20, 2006
Registered through: 2026
Brand names listed: Aquarell, Color Liquids, ICE Prettau, ICE Transluzent Plus, ICE Zirkon, ICE Zirkon Stains, SY1600 ZIRKONZAHN.Implant-Planner, SY1620 ZIRKONZAHN.Implant-Planner Practice and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Implant, Dental, Endosseous	NDP	1	Manufacturer	accessdata.fda.gov
Additively Manufactured, Preformed, Resin Denture Tooth	PZY	2	Manufacturer	accessdata.fda.gov
Alloy, Metal, Base	EJH	2	Manufacturer	accessdata.fda.gov
Articulators	EJP	1	Manufacturer	accessdata.fda.gov
Crown And Bridge, Long-Term Temporary, Resin	POW	2	Manufacturer	accessdata.fda.gov
Crown And Bridge, Temporary, Resin	EBG	2	Manufacturer	accessdata.fda.gov
Denture Preformed (Partially Prefabricated Denture)	EKO	2	Manufacturer	accessdata.fda.gov
Denture, Plastic, Teeth	ELM	2	Manufacturer	accessdata.fda.gov
Guide, Surgical, Instrument	FZX	1	Manufacturer	accessdata.fda.gov
Material, Impression Tray, Resin	EBH	1	Manufacturer	accessdata.fda.gov
Material, Tooth Shade, Resin	EBF	2	Manufacturer	accessdata.fda.gov
Mouthguard, Prescription	MQC	U	Manufacturer	accessdata.fda.gov
Powder, Porcelain	EIH	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Resin, Denture, Relining, Repairing, Rebasing	EBI	2	Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Manufacturer	accessdata.fda.gov
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	NOF	2	Manufacturer	accessdata.fda.gov
System, X-Ray, Film Marking, Radiographic	JAC	1	Manufacturer	accessdata.fda.gov
Wax, Dental, Intraoral	EGD	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 5, 2023	K232691	Polibond	EBI	Substantially Equivalent	Zirkonzahn Srl	accessdata.fda.gov
December 14, 2022	K213722	ICE Ceramics, ICE Stains, Fresco	EIH	Substantially Equivalent	Zirkonzahn Srl	accessdata.fda.gov
July 20, 2021	K203765	ZIRKONZAHN.Implant-Planner, ZIRKONZAHN.Implant-Planner Practice, CAD/CAM STL Converter, CAD/CAM Z-Tray	LLZ	Substantially Equivalent	Zirkonzahn Srl	accessdata.fda.gov
July 8, 2020	K200676	ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA	EBG	Substantially Equivalent	Zirkonzahn Srl	accessdata.fda.gov
November 22, 2019	K190518	Color Liquid, Vita Liquid	EIH	Substantially Equivalent	Zirkonzahn Srl	accessdata.fda.gov
April 4, 2019	K183304	Prettau, ICE, Z-White zirconia blanks	EIH	Substantially Equivalent	Zirkonzahn Srl	accessdata.fda.gov
June 28, 2018	K180562	TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT	EBG	Substantially Equivalent	Zirkonzahn GmbH	accessdata.fda.gov
June 18, 2018	K181484	Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue	EBF	Substantially Equivalent	Zirkonzahn Srl	accessdata.fda.gov
October 8, 2015	K151490	PRETTAU ANTERIOR T0	EIH	Substantially Equivalent	Zirkonzahn GmbH	accessdata.fda.gov
November 5, 2014	K132230	ICE ZIRKON TRANSLUZENT	EIH	Substantially Equivalent	Zirkonzahn Srl	accessdata.fda.gov
September 29, 2006	K061851	ZIRKONZAHN ICE	EIH	Substantially Equivalent	Zirkonzahn GmbH	accessdata.fda.gov

Compare with other makers

Updated September 5, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.