Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016505723

FEI Number

3016505723

Entity Name

Elemental NV

City/State/Country

Ghent Oost-Vlaanderen, BE

Establishment Address

Zuiderlaan 1 - 3 #8, Ghent Oost-Vlaanderen 9000, BE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Zinkh NV (Owner Number: 10080587)

Owner / Operator Contact Address

Zuiderlaan 1 - 3 #8, Ghent, BE-VOV 9000, BE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K241283

PMA Number

N/A

All Registered Proprietary Names

Elemental PerioPlast Elemental Granulate

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OLR	Oral Wound Dressing	Unknown	Class U	N/A	2025-01-08
EMA	Cement, Dental	Dental	Class 2	872.3275	2025-01-08

Official Correspondent

No official correspondent registered.

US Agent Details

Simon Ghosh Email: simon.ghosh@zinkh.com Phone: (949) 3072830

Related Public Records

Same Entity

Zinkh NV

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
K972485	Arent, Fox, Kintner, Plotkin & Kahn	CIMPAT N	1997-09-08
K982895	Sterngold/Implamed	STERNOMEGA COMPOMER CEMENT	1998-10-09
K033068	Voco GmbH	IONOFIL COLOR AC	2003-10-31
K062064	Southern Dental Industries, Inc.	RIVA BOND LC	2006-11-09
K940030	Bisco, Inc.	BISCO COMPOSITE	1994-02-04

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3013576473	ALLIANCE PHARMA SRL	Milan Lombardy, IT
3004146122	MAXIGEN BIOTECH, INC.	Taoyuan City, TW
2518467	ACCUPAC, LLC	MAINLAND, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016505723. Last updated year: 2026. Please use registration number 3016505723 when referencing this establishment in official correspondence.