Manufacturer registered with FDA
Identa Dental Material GmbH
CUXHAVEN, Germany. Lists 11 dental device types with FDA across 1 registered establishment.
- Device types listed
- 11
- Brands and models
- 45
- 510(k) clearances
- 0as applicant
- Markets registered in
- 22 registrations outside the US
- Establishments
- 1Germany
Registered in 2 markets
Where regulators' registries name Identa Dental Material GmbH as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Identa Dental Material GmbH | 11 device types | — | Below |
| Canada | Health Canada | Registration holder | IDENTA DENTAL MATERIAL GMBH | 2 | 2009–2009 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Identa Dental Material GmbH currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental CementEMA · Class 2 | Dental cements | Maker | IDENTA DC Adhesive LutingIDENTA Fast GIC Filling MolarIDENTA GIC Filling Molar + Fast & Flow ACIDENTA GIC Filling Molar + Regular ACIDENTA GIC Luting CapsIDENTA Resin-reinforced GIC LutingIDENTA Resin-reinforced GIC Luting / Application CapsulesIDENTA SE Adhesive LutingIDENTA Temp Luting | 1994 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | IDENTA LC Glass Ionomer RestorativeIDENTA LC Nano Hybrid CompositeIDENTA LC Nano Hybrid Flowable CompositeIDENTA LC Posterior FillIDENTA LC Posterior Fill FlowIDENTA LC Temp Filling | 2013 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Maker | IDENTA DC Nano-reinforced Self-etch BondIDENTA LC Nano-reinforced Self-etch BondIDENTA LC Nano-reinforced Self-etch One-component BondIDENTA Universal Bond Plus | 2005 |
| Calcium Hydroxide Cavity LinerEJK · Class 2 | — | Maker | IDENTA Calcium SC - in tubesIDENTA Calcium water-basedIDENTA LC GIC Composite | 2005 |
| Pit and Fissure Sealant and ConditionerEBC · Class 2 | Sealants & varnishes | Maker | IDENTA LC Nano Hybrid CompositeIDENTA LC Nano Hybrid Flowable Composite | 2013 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | IDENTA SC Temp C&B MaterialIDENTA SC Temp C&B Material 4:1IDENTA SC Temp C&B Material PlusIDENTA SC Temp C&B Material QM | 2005 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | IDENTA Hard Relining (1:1)IDENTA Soft Relining | 2013 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | IDENTA LC Base PlatesIDENTA LC Individual Trays | 2005 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Lister | IDENTA AC ActivatorIDENTA AC ApplicatorIDENTA Application Brushes for root canalIDENTA Application CannulaeIDENTA DispenserIDENTA Disposable BrushesIDENTA Fine Application BrushesIDENTA Intraoral TipsIDENTA Measuring spoonIDENTA Mixing Spatula for cements 1 moreIDENTA Mixing Tips | 2012 |
| Impression MaterialELW · Class 2 | Impression materials | Maker | IDENTA Bite Reg | 2005 |
| Cavity VarnishLBH · Class 2 | Sealants & varnishes | Maker | IDENTA Fluoride-containing Desensitizing Varnish | 2014 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| IDENTA DENTAL MATERIAL GMBHFDA reg. 9680144 | CUXHAVEN Lower Saxony, Germany | Contract manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9007069). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.