FDA Registration
Active
🇩🇪 Germany
IDENTA DENTAL MATERIAL GMBH
Reg #: 9680144
·
FEI: 3002729120
·
Expires 2026
Products
11
Proprietary Names
43
Establishment Types
2
Classifications
11
Registration Details
- Registration Name
- IDENTA DENTAL MATERIAL GMBH
- Registration Number
- 9680144
- FEI Number
- 3002729120
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- ANTON-FLETTNER-STRASSE 3
- City
- CUXHAVEN Lower Saxony
- Country
- DE
Owner / Operator
- Firm Name
- IDENTA DENTAL MATERIAL GMBH
- Operator Number
- 9007069
- Address
- ANTON-FLETTNER-STRASSE 3, --
- City
- CUXHAVEN
- State
- DE-NOTA
- Postal Code
- D-27472
- Country
- DE
- Correspondent
- DIETER - DR. HAPKE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cement, Dental | EMA | Class 2 | Dental | No | 2019-09-11 |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | Class 2 | Dental | No | 2015-02-13 |
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2013-07-16 |
| Agent, Tooth Bonding, Resin | KLE | Class 2 | Dental | No | 2015-01-28 |
| Sealant, Pit And Fissure, And Conditioner | EBC | Class 2 | Dental | No | 2013-06-10 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 2012-10-17 |
| Liner, Cavity, Calcium Hydroxide | EJK | Class 2 | Dental | No | 2005-11-14 |
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2005-11-14 |
| Material, Impression Tray, Resin | EBH | Class 1 | Dental | No | 2005-11-14 |
| Material, Impression | ELW | Class 2 | Dental | No | 2005-11-14 |
| Varnish, Cavity | LBH | Class 2 | Dental | No | 2014-05-09 |
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
IDENTA DC Adhesive Luting
IDENTA SE Adhesive Luting
IDENTA GIC Filling Molar + Fast & Flow AC
IDENTA Resin-reinforced GIC Luting / Application Capsules
IDENTA LC Nano-reinforced Self-etch Bond
IDENTA GIC Filling Molar + Regular AC
IDENTA Fluoride-containing Desensitizing Varnish
IDENTA LC Posterior Fill Flow
IDENTA SC Temp C&B Material 4:1
IDENTA LC Nano-reinforced Self-etch One-component Bond
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device