Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030515618

FEI Number

3030515618

Entity Name

Amann Girrbach AG

City/State/Country

Maeder Vorarlberg, AT

Establishment Address

Gewerbestrasse 10, Maeder Vorarlberg 6841, AT

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Amann Girrbach AG (Owner Number: 9093103)

Owner / Operator Contact Address

Amann Girrbach AG, Gewerbestrasse 10, Maeder, AT-8 6841, AT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Ceramill Zolid fx ML Ceramill Liquid fx Ceramill Zolid fx Clinometer Porus buttons long Bite fork total Bite fork partial Artex Quickbite Leipzig Nasion Joint support Tray handle Artex facebow Nasion vertically adjustable Axis plane pointer with screw NextDent Ortho Flex Ceramill HT+ white Zolid gen-x Zolid DRS Ceramill HT+ PS Zolid Bion 179130 Ceramill Map 200 179140-IDC IDC S1 179140 Ceramill Map 400 179130-IDC IDC S2 179560-IDC IDC S3 179560 Ceramill Map 600 179130NC Ceramill Map 200+ 179140NC Ceramill Map 400+ 179560N Ceramill Map600+ 179570 Ceramill Map FX Ceramill A-Splint Artex CR Limited Edition Gold Artex CP Artex CR Artex CT Artex BN Artex CPR Artex CN

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2015-09-24
NFS	Device, Jaw Tracking, For Monitoring Jaw Positions	Dental	Class 1	872.2060	2022-01-27
ELK	Teeth, Artificial, Backing And Facing	Dental	Class 1	872.3910	2021-01-20
EHL	Point, Abrasive	Dental	Class 1	872.6010	2024-05-21
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2012-05-29
KCR	Facebow	Dental	Class 1	872.3220	2006-10-05
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2012-03-07
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2021-05-20
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2021-05-20
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2021-05-20
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2022-01-27
ELJ	Teeth, Artificial, Posterior With Metal Insert	Dental	Class 1	872.3900	2021-01-20
DZP	Instrument, Diamond, Dental	Dental	Class 1	872.4535	2024-05-21
DYT	Maintainer, Space Preformed, Orthodontic	Dental	Class 1	872.5525	2021-01-20
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2017-09-22
NOF	System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	Dental	Class 2	872.3661	2015-12-18
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2022-01-27
MQC	Mouthguard, Prescription	Unknown	Class U	N/A	2020-01-08
EJQ	Wheel, Polishing Agent	Dental	Class 1	872.6010	2024-05-21
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2022-01-27
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2022-01-27
EJP	Articulators	Dental	Class 1	872.3150	2010-11-12
EEA	Plate, Base, Shellac	Dental	Class 1	872.6200	2021-01-20

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Amann Girrbach AG

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3005942449	Amann Girrbach North America, LP	Charlotte, NC, US

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
K952662	Jeneric/Pentron, Inc.	COMP=FLOW	1995-08-28
K171147	Bisco, Inc.	REVEAL Bulk	2017-08-04
K770922	Espe GmbH (Us)	DENTAL RESTORATIVE IN CAPSULES	1977-06-01
K153476	Kuraray Noritake Dental, Inc.	KATANA AVENCIA Block	2016-08-23

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 3030515618. Last updated year: 2026. Please use registration number 3030515618 when referencing this establishment in official correspondence.