Dental Device Guide
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Manufacturer registered with FDA

Helmut Zepf Medizintechnik GmbH

SEITINGEN, Germany. Lists 54 dental device types with FDA across 1 registered establishment.

FDA owner/operator8010277Contract manufacturerForeign exporterManufacturer
Device types listed
54
Brands and models
0
510(k) clearances
0as applicant
Markets registered in
103,310 registrations outside the US
Establishments
1Germany

Registered in 10 markets

Where regulators' registries name Helmut Zepf Medizintechnik GmbH as the manufacturer or the registration holder of a device.

All markets
United States: 54 device types listedThailand: 3,004 registrationsSouth Korea: 112 registrationsSaudi Arabia: 53 registrationsColombia: 47 registrationsUnited Kingdom: 38 registrationsBrazil: 28 registrationsTaiwan: 15 registrationsAustralia: 12 registrationsIsrael: 1 registrations
RegisteredHome: GermanyOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerHelmut Zepf Medizintechnik GmbH54 device types—Below
ThailandThai FDAManufacturerHELMUT ZEPF MEDIZINTECHNIK GMBH.3,004—Pure Global AI
South KoreaMFDSManufacturerHelmut Zepf Medizintechnik GmbHHelmut Zepf Medizintechnik GMBH. · Helmut Zepf Medizintechnik GMBH · +21122000–2026Pure Global AI
Saudi ArabiaSFDAManufacturerHelmut Zepf Medizintechnik GmbH53—Pure Global AI
ColombiaINVIMAManufacturerHELMUT ZEPF, MEDIZINTECHNIK GMBHHELMUT ZEPF MEDIZINTECHNIK GMBH47—Pure Global AI
United KingdomMHRAManufacturerHelmut Zepf Medizintechnik GmbH38—Pure Global AI
BrazilANVISAManufacturerHELMUT ZEPF MEDIZINTECHNIK GMBH282011–2023Pure Global AI
TaiwanTFDAManufacturerHELMUT ZEPF MEDIZINTECHNIK GMBHHelmut Zepf Medizintechnik GmbH152006–2021Pure Global AI
AustraliaTGAManufacturerHelmut Zepf Medizintechnik GmbH122011–2015Pure Global AI
IsraelAMARManufacturerHelmut Zepf Medizintechnik GmbH1—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 Helmut Zepf Medizintechnik GmbH currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Intraoral Dental DrillDZA · Class 1Surgical drills & motorsMaker—2013
Orthodontic WireDZC · Class 1Orthodontic wires & bandsMaker—2001
Intraosseous Fixation ScrewDZL · Class 2Maxillofacial plates & screwsMaker—2013
Dental Hand InstrumentsDZN · Class 1Dental hand instrumentsMaker—2013
Mouth MirrorEAX · Class 1Dental hand instrumentsMaker—1997
Air and/or Water Syringe UnitECB · Class 1Dental hand instrumentsMaker—1989
Orthodontic Preformed BandECM · Class 1Orthodontic wires & bandsMaker—1989
Orthodontic Ligature Tucking InstrumentECP · Class 1Dental hand instrumentsMaker—2013
Orthodontic Band SetterECR · Class 1Dental hand instrumentsMaker—1989
Orthodontic Band PusherECS · Class 1Dental hand instrumentsMaker—1989
Orthodontic Band DriverECT · Class 1Dental hand instrumentsMaker—1989
Articulation Paper ForcepsEFK · Class 1Dental hand instrumentsMaker—1989
Dental Surgical Tissue ScissorsEGN · Class 1Dental hand instrumentsMaker—1996
Prophylaxis CupEHK · Class 1Polishing & prophylaxisMaker—2011
Preformed BarEHO · Class 1—Maker—1992
Oral Cavity EvacuatorEHZ · Class 1Suction & evacuation unitsMaker—1997
Restorative and Impression Material SyringeEID · Class 1Dental hand instrumentsMaker—2013
All Types RetractorEIG · Class 1Dental hand instrumentsMaker—1996
Dental Wax CarverEIK · Class 1Dental hand instrumentsMaker—1989
Dental Instrument Depth GaugeEIL · Class 1Dental hand instrumentsMaker—1992
Collar and Crown ScissorsEIR · Class 1Dental hand instrumentsMaker—1996
Crown RemoverEIS · Class 1Dental hand instrumentsMaker—1996
Periodontic ProbeEIX · Class 1Dental hand instrumentsMaker—1997
Dental Plastic Filling InstrumentEIY · Class 1Dental hand instrumentsMaker—1997
Dental Instrument HandleEJB · Class 1Dental hand instrumentsMaker—1997
Rubber Dam Clamp ForcepsEJG · Class 1Rubber dam systemsMaker—1989
Dental BurEJL · Class 1Dental burs & diamondsMaker—1998
Operative PliersEJY · Class 1Dental hand instrumentsMaker—1996
Operative Margin Finishing KnifeEJZ · Class 1Dental hand instrumentsMaker—2013
Operative ExplorerEKB · Class 1Dental hand instrumentsMaker—1997
Operative Dental ExcavatorEKC · Class 1Dental hand instrumentsMaker—1996
Operative CuretteEKE · Class 1Dental hand instrumentsMaker—2013
Operative Amalgam and Foil CondenserEKG · Class 1Dental hand instrumentsMaker—1989
Operative Dental Amalgam CarverEKH · Class 1Dental hand instrumentsMaker—1989
Operative Amalgam CarrierEKI · Class 1Dental hand instrumentsMaker—1989
Operative BurnisherEKJ · Class 1Dental hand instrumentsMaker—1989
Endodontic Pulp Canal Filling Material SpreaderEKK · Class 1Dental hand instrumentsMaker—2012
Endodontic Root Canal PluggerEKR · Class 1Dental hand instrumentsMaker—1989
Endodontic CuretteEKT · Class 1Dental hand instrumentsMaker—2017
Surgical HemostatEMD · Class 1Dental hand instrumentsMaker—2013
Surgical Tooth Extractor ForcepsEMG · Class 1Dental hand instrumentsMaker—1988
Surgical Rongeur ForcepsEMH · Class 1Dental hand instrumentsMaker—1982
Surgical Bone FileEMI · Class 1Dental hand instrumentsMaker—1989
Dental Surgical ElevatorEMJ · Class 1Dental hand instrumentsMaker—1996
Dental Surgical CuretteEMK · Class 1Dental hand instrumentsMaker—1996
Surgical Bone ChiselEML · Class 1Dental hand instrumentsMaker—1989
Surgical Osteotome ChiselEMM · Class 1Dental hand instrumentsMaker—1989
Periodontic ScalerEMN · Class 1Dental hand instrumentsMaker—1996
Periodontic KnifeEMO · Class 1Dental hand instrumentsMaker—2012
Periodontic FileEMR · Class 1Dental hand instrumentsMaker—1997
Periodontic CuretteEMS · Class 1Dental hand instrumentsMaker—2012
Matrix RetainerJEP · Class 1Dental hand instrumentsMaker—2011
Orthodontic PlierJEX · Class 1Dental hand instrumentsMaker—1988
Endosseous Dental Implant AccessoriesNDP · Class 1Implant instruments & surgical kitsMaker—2013

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

Also lists devices cleared under other names

Helmut Zepf Medizintechnik GmbH lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.

Original applicants: Miltex, Inc. (1).

Decided510(k)DeviceApplicantDevice type
29 Dec 2009K092855MILTEX MEMBRANE TACK KITMiltex, Inc.DZL Intraosseous Fixation Screw

Registered establishments

EstablishmentLocationWhat it does
HELMUT ZEPF MEDIZINTECHNIK GMBHFDA reg. 9611367SEITINGEN Baden-Wurttemberg, GermanyContract manufacturer, Foreign exporter, Manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 8010277). 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.