Manufacturer registered with FDA
Storz AM Mark GmbH
EMMINGEN-LIPTINGEN, Germany. Lists 51 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 51
- Brands and models
- 101
- 510(k) clearances
- 22005–2008
- Markets registered in
- 413 registrations outside the US
- Establishments
- 1Germany
510(k) clearances per year, 2000–2026
Registered in 4 markets
Where regulators' registries name Storz AM Mark GmbH as the manufacturer or the registration holder of a device.
RegisteredHome: GermanyOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Storz AM Mark GmbH | 2 clearances | 2005–2008 | Below |
| Taiwan | TFDA | Manufacturer | STORZ AM MARK GMBHStorz Am Mark GmbH | 11 | 2008–2025 | Pure Global AI |
| European Union | EUDAMED | Registration holder | Storz am Mark GmbH | 1 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Storz am Mark GmbH | 1 | — | 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 Storz AM Mark 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 |
|---|---|---|---|---|
| Intraosseous Fixation ScrewDZL · Class 2 | Maxillofacial plates & screws | Maker | micro-screwTitanium screw | 2005 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Lister | Pilot Drill | 2014 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | ApplicatorBone block forcepsCement spatulaCleoid discoidExplorerFistula probePluggerProbeWax knife1001001 / 260-801-165 3 more1001002 / 260-801-0551001003 / 260-801-0561001004 / 260-801-002 | 2005 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Lister | Cheek retractor mirrorMirrorMouth mirror | 2005 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Lister | Spare cannula for water syringeWater syringe | 2005 |
| Orthodontic Band SetterECR · Class 1 | Dental hand instruments | Maker | Band setter, Ligature Applicator | 1999 |
| Rubber Dam ClampEEF · Class 1 | Rubber dam systems | Maker | Rubber dam clamp | 1999 |
| Articulation Paper ForcepsEFK · Class 1 | Dental hand instruments | Maker | Articulating Paper Tweezers | 1999 |
| Dental Dressing ForcepsEFL · Class 1 | Dental hand instruments | Maker | ForcepsTweezers | 2005 |
| Dental Surgical Tissue ScissorsEGN · Class 1 | Dental hand instruments | Maker | Micro-ScissorsScissorsTissue Scissors1001070 / ISCRS | 2005 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Lister | Impression tray | 2005 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | 1001110 / IRC | 2016 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | HookRetractor | 2005 |
| Dental Wax CarverEIK · Class 1 | Dental hand instruments | Maker | Wax instrument | 2005 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Maker | Gauge | 2005 |
| Collar and Crown ScissorsEIR · Class 1 | Dental hand instruments | Maker | Crown scissors | 2005 |
| Crown RemoverEIS · Class 1 | Dental hand instruments | Maker | Crown butlerCrown removerCrown spreader | 2005 |
| Periodontic ProbeEIX · Class 1 | Dental hand instruments | Maker | Periodontal probePeriodontometerPeriodontometer tip | 2005 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Maker | Amalgam applicatorBurnisherComposite instrumentFilling instrumentFissure instrumentPluggerSpatula | 2005 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | Stomaform-handel, handle, scalpel-handle, mirror and probe handle, scalpel blade holder, mirror handle, special handle | 1999 |
| Rubber Dam Clamp ForcepsEJG · Class 1 | Rubber dam systems | Lister | Rubber dam clamp forcepsRubber dam punch | 2005 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | Drill bitPilot drillTissue punchTrephine | 2004 |
| Operative PliersEJY · Class 1 | Dental hand instruments | Maker | Pliers | 1999 |
| Operative ExplorerEKB · Class 1 | Dental hand instruments | Lister | Explorer | 2005 |
| Operative Dental ExcavatorEKC · Class 1 | Dental hand instruments | Maker | Excavator | 2005 |
| Operative Cutting InstrumentEKD · Class 1 | Dental hand instruments | Maker | Cutting Instrument | 1999 |
| Operative CuretteEKE · Class 1 | Dental hand instruments | Maker | Scraper, Sharp spoon, Bone scraper | 2005 |
| Operative Dental Amalgam CarverEKH · Class 1 | Dental hand instruments | Maker | Amalgam carverModelling instrument | 2005 |
| Operative Amalgam CarrierEKI · Class 1 | Dental hand instruments | Maker | Amalgam carrier | 2005 |
| Operative BurnisherEKJ · Class 1 | Dental hand instruments | Maker | Burnisher | 2005 |
| Endodontic Pulp Canal Filling Material SpreaderEKK · Class 1 | Dental hand instruments | Maker | Spreader | 1999 |
| Endodontic Root Canal PluggerEKR · Class 1 | Dental hand instruments | Maker | Root canal plugger | 2005 |
| Endodontic CuretteEKT · Class 1 | Dental hand instruments | Maker | Curette | 2005 |
| Calculus Removal Hand InstrumentELA · Class 1 | Dental hand instruments | Maker | Scaler | 2005 |
| Surgical Biopsy PunchEME · Class 1 | Dental hand instruments | Maker | Tissue punch | 2005 |
| Surgical Tooth Extractor ForcepsEMG · Class 1 | Dental hand instruments | Maker | Extracting forcepsForceps | 2005 |
| Surgical Rongeur ForcepsEMH · Class 1 | Dental hand instruments | Maker | Bone rongeur forcepsRongeur | 2005 |
| Surgical Bone FileEMI · Class 1 | Dental hand instruments | Maker | File, Bone File, Interdental File | 1999 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Maker | ElevatorLuxelevator | 2005 |
| Dental Surgical CuretteEMK · Class 1 | Dental hand instruments | Maker | Curette | 2005 |
| Surgical Bone ChiselEML · Class 1 | Dental hand instruments | Maker | ChiselGauge | 2005 |
| Surgical Osteotome ChiselEMM · Class 1 | Dental hand instruments | Maker | Osteotome | 2004 |
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Maker | color-stick scalerScaler | 2005 |
| Periodontic KnifeEMO · Class 1 | Dental hand instruments | Maker | Gingivectomy knifePeriotomeTunnel-instrument | 2005 |
| Periodontic MarkerEMP · Class 1 | Dental hand instruments | Maker | Pocket Marking Tweezers | 2005 |
| Periodontic HoeEMQ · Class 1 | Dental hand instruments | Maker | Hoe, periodontic | 2005 |
| Periodontic FileEMR · Class 1 | Dental hand instruments | Maker | File | 2005 |
| Periodontic CuretteEMS · Class 1 | Dental hand instruments | Maker | color-stick curetteCuretteScraper | 2005 |
| Matrix RetainerJEP · Class 1 | Dental hand instruments | Lister | Matrix bandMatrix retainer | 2005 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | Wire forceps, Rubber ring removing forceps, Flat pliers, Round pliers, Pin bending pliers, Wire bending pliers | 2005 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Handle for screwdriverInsertScrewdriverTip for contra angled piece1001005 / 260-801-001 | 2005 |
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 |
|---|---|---|
| STORZ AM MARK GMBHFDA reg. 8043554 | EMMINGEN-LIPTINGEN Baden-Wurttemberg, Germany | Contract manufacturer, Manufacturer, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9002328). 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.