Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013557697

FEI Number

3013557697

Entity Name

Itena Clinical Villepinte

City/State/Country

Villepinte Seine-Saint-Denis, FR

Establishment Address

97 Allee de la Louve, Villepinte Seine-Saint-Denis 93420, FR

Establishment Type(s)

Foreign Private Label Distributor

Owner / Operator

ITENA Clinical (Owner Number: 10045822)

Owner / Operator Contact Address

Central Parc Batiment B, 97 Allee de la Louve, Villepinte, FR-IDF 93420, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CEMENT, DENTAL CEMENT, DENTAL ROOT CANAL AGENT, TOOTH BONDING, RESIN DISK, ABRASIVE EBC / SEALANT, PIT AND FISSURE, AND CONDITIONER RESIN, ROOT CANAL FILLING AGENT, TOOTH BONDING, RESIN APPLICATOR, RESIN DRILL, DENTAL, INTRAORAL HANDLE, INSTRUMENT, DENTAL Material, tooth shade, resin Material, tooth shade, resin Material, tooth shade, resin POINT, ABRASIVE RESIN, ROOT CANAL FILLING CEMENT, DENTAL RESIN, ROOT CANAL FILLING

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EMA	Cement, Dental	Dental	Class 2	872.3275	2014-10-06
EMA	Cement, Dental	Dental	Class 2	872.3275	2016-09-25
ELR	Post, Root Canal	Dental	Class 1	872.3810	2014-10-06
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2013-12-31
EHJ	Disk, Abrasive	Dental	Class 1	872.6010	2016-09-25
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2014-10-06
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2022-11-07
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2016-09-25
KXR	Applicator, Resin	Dental	Class 1	872.3140	2014-10-06
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2014-10-06
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2014-10-06
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2013-12-31
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2013-12-31
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2013-12-31
EHL	Point, Abrasive	Dental	Class 1	872.6010	2016-09-25
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2017-09-19
EMA	Cement, Dental	Dental	Class 2	872.3275	2016-09-25
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2018-08-22

Official Correspondent

Alexandra PETIT

US Agent Details

Marilyne Joly Business: LOK USA, Inc. Email: regulatory@lok-northamerica.com Phone: (412) 2851076

Related Public Records

Same Entity

ITENA Clinical

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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Z-0036-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.
Z-0028-2020	Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany	2	Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).

Similar Registrations

Registration Number	Establishment Name	Location
8030419	SUN MEDICAL CO., LTD.	Moriyama Shiga, JP
3043226252	ZAPALIGN LLC	Fort Lauderdale, FL, US
3035693034	Solventum Germany GmbH	Kist Bavaria, DE
3012421607	MAINLINE MEDICAL DENTAL SUPPLY	North York Ontario, CA
3003775534	GC EUROPE N.V.	LEUVEN Vlaams Brabant, BE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013557697. Last updated year: 2026. Please use registration number 3013557697 when referencing this establishment in official correspondence.