Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009740550

FEI Number

3009740550

Entity Name

KEROX KFT.

City/State/Country

Soskut Pest, HU

Establishment Address

Kerox Utca 1, Soskut Pest 2038, HU

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Kerox Kft. (Owner Number: 10041432)

Owner / Operator Contact Address

1 kerox st, Soskut, HU-BU 2038, HU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K120852

PMA Number

N/A

All Registered Proprietary Names

Kerox Dental Zircostar Kerox Dental Zircostar Zirconia Blank

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2012-07-23

Official Correspondent

No official correspondent registered.

US Agent Details

Alan Schwartz Business: mdi Consultants, Inc. Email: Alan@mdiconsultants.com Phone: (516) 4829001

Related Public Records

Same Entity

Kerox Kft.

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 3009740550. Last updated year: 2026. Please use registration number 3009740550 when referencing this establishment in official correspondence.