Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3019741877

FEI Number

3019741877

Entity Name

ZARC4ENDO

City/State/Country

GIJON Asturias, ES

Establishment Address

Calle Concejo de Tapia de Casariego, 1- Loc, GIJON Asturias 33204, ES

Establishment Type(s)

Foreign Private Label Distributor

Owner / Operator

Zarc4Endo S.A. (Owner Number: 10085865)

Owner / Operator Contact Address

Calle Concejo de Tapia de Casariego, 1- Local, GIJÓN, ES-AS 33204, ES

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Z-UP System Z Micro-Opener Z Micro-Shaper Z-DOWN System Paper Points Excalibur Paper Points Zarc Paper Points ApicalShaper Paper Points Z-Fit Paper Points BlueShaper Paper Points SlimShaper Paper Points NanoShaper NiTi files BlueShaper NiTi files Z-Condensor NiTi files Excalibur NiTi files BlueShaper PRO NiTi RetreatAll NiTi files Z-Glider Z-Plugger K Flex NiTi files ApicalShaper Hedstroem File NiTi files SlimShaper C+ File NiTi files NanoShaper K File NiTi files Excalibur Glider PRO NiTi files Z-Glider EVO NiTi files Excalibur Glider NiTi files SlimShaper PRO NiTi files Excalibur PRO Z-Activator Endo-Block Ruler Z-Gauge Ruler Z-Rinse

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EKR	Plugger, Root Canal, Endodontic	Dental	Class 1	872.4565	2022-08-24
EKN	Point, Paper, Endodontic	Dental	Class 1	872.3830	2022-08-24
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2022-08-24
JET	Pick, Massaging	Dental	Class 1	872.6650	2022-08-24
EIL	Gauge, Depth, Instrument, Dental	Dental	Class 1	872.4565	2022-08-24
EIC	Syringe, Periodontic, Endodontic, Irrigating	Dental	Class 1	872.4565	2022-10-27

Official Correspondent

MARIA JOSE CALDERON DIEZ

US Agent Details

Diane Johnson Krueger Business: NuSmile LTD Email: djohnson@nusmile.com Phone: (713) 8610033

Related Public Records

Same Entity

Zarc4Endo S.A.

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
K864976	Endo Technic Corp.	SOLUSET CALCIUM DEMINERALIZING SOLUTION	1987-02-27
K821629	Moyco Industries, Inc.	FIXIDENT	1982-06-14

Similar Registrations

Registration Number	Establishment Name	Location
3007064566	POMEE CORPORATION	Sialkot Punjab, PK
3005067367	SHANGHAI MEDICAL INSTRUMENTS (GROUP) LTD. CORP.	Shanghai, CN
8010159	A. SCHWEICKHARDT GMBH & CO. KG	Seitingen-Oberflacht Baden-Wurttemberg, DE
3008808049	SURGICRAFTS	Sialkot Punjab, PK
3004168759	CENTRAL SURGICAL CO. PVT. LTD.	Sialkot Punjab, PK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019741877. Last updated year: 2026. Please use registration number 3019741877 when referencing this establishment in official correspondence.