Data / Medical devices / Austria / Amann Girrbach AG

Amann Girrbach AG: FDA-registered device maker in Maeder Vorarlberg, Austria, 11 510(k) clearances

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

Amann Girrbach AG is registered with the FDA (registration 3030515618) in Maeder Vorarlberg, Austria. It lists 20 device types. The FDA files 11 510(k) clearances under its listings, the newest dated June 29, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3030515618
Address: Gewerbestrasse 10, Maeder Vorarlberg, Austria, 6841
Owner or operator: Amann Girrbach AG (9093103)
Roles: Complaint file establishment, Exporter to the US, Foreign private label distributor, Manufacturer
First device listed: October 5, 2006
Registered through: 2026
Brand names listed: 179130 Ceramill Map 200, 179130-IDC IDC S2, 179130NC Ceramill Map 200+, 179140 Ceramill Map 400, 179140-IDC IDC S1, 179140NC Ceramill Map 400+, 179560 Ceramill Map 600, 179560-IDC IDC S3 and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Implant, Dental, Endosseous	NDP	1	Exporter to the US	accessdata.fda.gov
Alloy, Metal, Base	EJH	2	Complaint file establishment, Exporter to the US, Manufacturer	accessdata.fda.gov
Articulators	EJP	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Crown And Bridge, Long-Term Temporary, Resin	POW	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Crown And Bridge, Temporary, Resin	EBG	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Device, Jaw Tracking, For Monitoring Jaw Positions	NFS	1	Exporter to the US	accessdata.fda.gov
Facebow	KCR	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Instrument, Diamond, Dental	DZP	1	Exporter to the US	accessdata.fda.gov
Maintainer, Space Preformed, Orthodontic	DYT	1	Exporter to the US	accessdata.fda.gov
Material, Impression Tray, Resin	EBH	1	Exporter to the US	accessdata.fda.gov
Material, Tooth Shade, Resin	EBF	2	Exporter to the US	accessdata.fda.gov
Mouthguard, Prescription	MQC	U	Exporter to the US, Manufacturer	accessdata.fda.gov
Plate, Base, Shellac	EEA	1	Exporter to the US	accessdata.fda.gov
Point, Abrasive	EHL	1	Exporter to the US	accessdata.fda.gov
Powder, Porcelain	EIH	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Resin, Denture, Relining, Repairing, Rebasing	EBI	2	Exporter to the US	accessdata.fda.gov
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	NOF	2	Exporter to the US, Foreign private label distributor	accessdata.fda.gov
Teeth, Artificial, Backing And Facing	ELK	1	Exporter to the US	accessdata.fda.gov
Teeth, Artificial, Posterior With Metal Insert	ELJ	1	Exporter to the US	accessdata.fda.gov
Wheel, Polishing Agent	EJQ	1	Exporter to the US	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
June 29, 2026	K260918	Zolid Lunaris	EIH	Substantially Equivalent	Amann Girrbach AG	accessdata.fda.gov
December 20, 2019	K191836	Ceramill A-Splint	MQC	Substantially Equivalent	Amann Girrbach AG	accessdata.fda.gov
November 1, 2019	K191497	NextDent Denture 3D+	EBI	Substantially Equivalent	Vertex-Dental B.V.	accessdata.fda.gov
October 4, 2019	K191843	Ceramill A-Temp	EBG	Substantially Equivalent	Amann Girrbach AG	accessdata.fda.gov
December 21, 2018	K181331	JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White	EBI	Substantially Equivalent	Juvora, Ltd.	accessdata.fda.gov
September 20, 2017	K171876	Ceramill Zolid HT+ white	EIH	Substantially Equivalent	Amann Girrbach AG	accessdata.fda.gov
September 21, 2015	K152383	Ceramill Zolid FX	EIH	Substantially Equivalent	Emergo Europe Consulting	accessdata.fda.gov
January 31, 2014	K132070	VITA SUPRINITY(R)	EIH	Substantially Equivalent	Vita Zahnfabrik H.Rauter GmbH & Co.	accessdata.fda.gov
December 13, 2012	K122269	ENAMIC	EIH	Substantially Equivalent	Vita Zahnfabrik H.Rauter GmbH & Co.	accessdata.fda.gov
August 11, 2010	K102128	VITABLOCS	EIH	Substantially Equivalent	Vita Zahnfabrik H.Rauter GmbH & Co.	accessdata.fda.gov
February 2, 2007	K063511	CERAMILL ZI	EIH	Substantially Equivalent	Amann Girrbach America, Inc.	accessdata.fda.gov

Compare with other makers

Updated June 29, 2026. 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.