Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005942449

FEI Number

3005942449

Entity Name

Amann Girrbach North America, LP

City/State/Country

Charlotte, NC, US

Establishment Address

13900 South Lakes Drive, Suite D, Charlotte, NC 28273, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

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 A-Splint Ceramill HT+ white Zolid gen-x Zolid DRS Ceramill HT+ PS Zolid Bion Ceramill ZI CAM Ceramill ZI Ceramill Liquid new formula Ceramill Liquid Ceramill A-Temp Ceramill A-Temp ML Ceramill Sintron

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MQC	Mouthguard, Prescription	Unknown	Class U	N/A	2020-01-08
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2017-09-22
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2007-02-21
POW	Crown And Bridge, Long-Term Temporary, Resin	Dental	Class 2	872.3770	2019-10-25
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2019-10-25
EJH	Alloy, Metal, Base	Dental	Class 2	872.3710	2006-10-05

Official Correspondent

Debora Engel

US Agent Details

No US Agent registered (Local establishment).

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
3030515618	Amann Girrbach AG	Maeder Vorarlberg, AT

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
K810521	C.Vaupel Dental, Inc.	CO-SPAN 13.5 CASTING ALLOY	1981-03-17

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

Similar Registrations

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2086043	PAC-DENT INC.	Brea, CA, US
3010279788	Formlabs Inc.	Somerville, MA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005942449. Last updated year: 2026. Please use registration number 3005942449 when referencing this establishment in official correspondence.