Data / Medical devices / United States / Amann Girrbach North America, LP

Amann Girrbach North America, LP: FDA-registered device maker in Charlotte, NC, United States, 6 510(k) clearances

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

Amann Girrbach North America, LP is registered with the FDA (registration 3005942449) in Charlotte, NC, United States. It lists 9 device types. The FDA files 6 510(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: 3005942449
Address: 13900 South Lakes Drive Suite D, Charlotte, NC, United States, 28273
Owner or operator: Amann Girrbach AG (9093103)
Roles: Complaint file establishment
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
Alloy, Metal, Base	EJH	2	Complaint file establishment	accessdata.fda.gov
Articulators	EJP	1	Complaint file establishment	accessdata.fda.gov
Crown And Bridge, Long-Term Temporary, Resin	POW	2	Complaint file establishment	accessdata.fda.gov
Crown And Bridge, Temporary, Resin	EBG	2	Complaint file establishment	accessdata.fda.gov
Device, Jaw Tracking, For Monitoring Jaw Positions	NFS	1	Complaint file establishment	accessdata.fda.gov
Facebow	KCR	1	Complaint file establishment	accessdata.fda.gov
Mouthguard, Prescription	MQC	U	Complaint file establishment	accessdata.fda.gov
Powder, Porcelain	EIH	2	Complaint file establishment	accessdata.fda.gov
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	NOF	2	Complaint file establishment	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
October 4, 2019	K191843	Ceramill A-Temp	EBG	Substantially Equivalent	Amann Girrbach AG	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
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.