Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014945384

FEI Number

3014945384

Entity Name

AMSUSA LLC

City/State/Country

Atlanta, GA, US

Establishment Address

4025 Pleasantdale Rd Ste 540, Atlanta, GA 30340, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

AMSUSA (Owner Number: 10058826)

Owner / Operator Contact Address

4025 Pleasantdale Rd, STE 540, Atlanta, GA 30340, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K163238

PMA Number

N/A

All Registered Proprietary Names

ECLIPSE 1 ECLIPSE KISS ECLIPSE KISS Zirconia ECLIPSE KISS PLUS ECLIPSE 2 KISS Coloring Liquid ECLIPSE ECLIPSE Coloring Liquid ECLIPSE 2 PLUS ECLIPSE Multi Layer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2018-10-31

Official Correspondent

Youngjin Kim

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

AMSUSA

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

View Entity Profile →

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

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 3014945384. Last updated year: 2026. Please use registration number 3014945384 when referencing this establishment in official correspondence.