Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680144

FEI Number

3002729120

Entity Name

IDENTA DENTAL MATERIAL GMBH

City/State/Country

CUXHAVEN Lower Saxony, DE

Establishment Address

ANTON-FLETTNER-STRASSE 3, CUXHAVEN Lower Saxony D-27472, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

IDENTA DENTAL MATERIAL GMBH (Owner Number: 9007069)

Owner / Operator Contact Address

ANTON-FLETTNER-STRASSE 3, --, CUXHAVEN, DE-NOTA D-27472, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

IDENTA Fast GIC Filling Molar IDENTA Hard Relining (1:1) IDENTA LC Temp Filling IDENTA Temp Luting IDENTA Universal Bond Plus IDENTA LC Nano Hybrid Composite IDENTA GIC Luting Caps IDENTA Soft Relining IDENTA Measuring spoon IDENTA Disposable Brushes IDENTA Intraoral Tips IDENTA AC Applicator IDENTA Dispenser IDENTA Mixing Tips IDENTA AC Activator IDENTA Mixing Spatula for cements IDENTA Fine Application Brushes IDENTA Application Cannulae IDENTA Application Brushes for root canal IDENTA DC Nano-reinforced Self-etch Bond IDENTA Calcium water-based IDENTA Resin-reinforced GIC Luting IDENTA LC Glass Ionomer Restorative IDENTA LC Nano Hybrid Flowable Composite IDENTA LC GIC Composite IDENTA SC Temp C&B Material QM IDENTA SC Temp C&B Material Plus IDENTA SC Temp C&B Material IDENTA LC Individual Trays IDENTA LC Base Plates IDENTA Bite Reg IDENTA Calcium SC - in tubes IDENTA LC Posterior Fill

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EMA	Cement, Dental	Dental	Class 2	872.3275	2019-09-11
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2015-02-13
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2013-07-16
EMA	Cement, Dental	Dental	Class 2	872.3275	1994-02-25
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2015-01-28
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2013-06-10
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2013-06-10
EMA	Cement, Dental	Dental	Class 2	872.3275	2014-12-17
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2013-06-10
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2012-10-17
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2019-09-03
EJK	Liner, Cavity, Calcium Hydroxide	Dental	Class 2	872.3250	2005-11-14
EMA	Cement, Dental	Dental	Class 2	872.3275	2021-02-05
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2019-04-23
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2013-06-10
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2013-06-10
EJK	Liner, Cavity, Calcium Hydroxide	Dental	Class 2	872.3250	2016-05-31
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2005-11-14
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2005-11-14
ELW	Material, Impression	Dental	Class 2	872.3660	2005-11-14
EJK	Liner, Cavity, Calcium Hydroxide	Dental	Class 2	872.3250	2019-02-13
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2013-07-16

Official Correspondent

DIETER DR. HAPKE

US Agent Details

Leif Ebert Email: L.Ebert@voco.com Phone: (888) 6582584

Related Public Records

Same Entity

IDENTA DENTAL MATERIAL GMBH

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-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.).
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.

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 9680144. Last updated year: 2026. Please use registration number 9680144 when referencing this establishment in official correspondence.