Manufacturer registered with FDA

Zepf Medical Instrum

SEITINGEN-OBERFLACHT, Germany. Lists 17 dental device types with FDA across 1 registered establishment.

FDA owner/operator9045716Manufacturer

Device types listed: 17
Brands and models: 15
510(k) clearances: 0as applicant
Markets registered in: 116,823 registrations outside the US
Establishments: 1Germany

Registered in 11 markets

Where regulators' registries name Zepf Medical Instrum 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	Zepf Medical Instrum	17 device types	—	Below
Thailand	Thai FDA	Manufacturer	Zepf Medical Instruments GmbHZEPF MEDICAL INSTRUMENTS GMBH	6,341	—	Pure Global AI
European Union	EUDAMED	Manufacturer	Zepf Medical Instruments GmbH	257	—	Pure Global AI
Australia	TGA	Manufacturer	Zepf Medical Instruments GmbH	107	2007–2018	Pure Global AI
United Kingdom	MHRA	Manufacturer	Zepf Medical Instruments Gmbh	54	—	Pure Global AI
Costa Rica	Ministerio de Salud	Manufacturer	ZEPF MEDICAL INSTRUMENTS GMBH	28	—	Pure Global AI
Peru	DIGEMID	Manufacturer	ZEPF MEDICAL INSTRUMENTS GmbHZEPF MEDICAL INSTRUMENTS GMBH	26	2020–2026	Pure Global AI
Colombia	INVIMA	Manufacturer	ZEPF MEDICAL INSTRUMENTS GMBH	3	—	Pure Global AI
Israel	AMAR	Manufacturer	ZEPF MEDICAL INSTRUMENTS GMBH	3	—	Pure Global AI
Taiwan	TFDA	Manufacturer	ZEPF MEDICAL INSTRUMENTS GMBH	3	2012–2022	Pure Global AI
Hong Kong	MDD	Manufacturer	Zepf Medical Instruments GmbH	1	2026–2026	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 Zepf Medical Instrum currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Mouth MirrorEAX · Class 1	Dental hand instruments	Maker	—	2001
Orthodontic Band PusherECS · Class 1	Dental hand instruments	Maker	BANDPUSHER	2001
Articulation Paper ForcepsEFK · Class 1	Dental hand instruments	Maker	ARTICULATION PAPERFORCEPS	2001
Dental Dressing ForcepsEFL · Class 1	Dental hand instruments	Maker	FORCEPS	2001
Dental Surgical Tissue ScissorsEGN · Class 1	Dental hand instruments	Maker	—	2001
All Types RetractorEIG · Class 1	Dental hand instruments	Maker	RETRACTOR	2001
Crown RemoverEIS · Class 1	Dental hand instruments	Maker	—	2001
Dental Plastic Filling InstrumentEIY · Class 1	Dental hand instruments	Maker	—	2001
Rubber Dam Clamp ForcepsEJG · Class 1	Rubber dam systems	Maker	FORCEPSRUBBER DAM CLAMP	2001
Operative Amalgam and Foil CondenserEKG · Class 1	Dental hand instruments	Maker	AMALGAM AND FOIL	2001
Operative Amalgam CarrierEKI · Class 1	Dental hand instruments	Maker	AMALGAM	2001
Surgical Tooth Extractor ForcepsEMG · Class 1	Dental hand instruments	Maker	FORCEPS	2001
Surgical Rongeur ForcepsEMH · Class 1	Dental hand instruments	Maker	FORCEPS	2001
Surgical Bone FileEMI · Class 1	Dental hand instruments	Maker	FILE	2001
Dental Surgical ElevatorEMJ · Class 1	Dental hand instruments	Maker	ELEVATOR	2001
Surgical Bone ChiselEML · Class 1	Dental hand instruments	Maker	—	2001
Periodontic FileEMR · Class 1	Dental hand instruments	Maker	FILE	2001

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
ZEPF MEDICAL INSTRUMENTS GMBHFDA reg. 3003244954	SEITINGEN-OBERFLACHT Baden-Wurttemberg, Germany	Manufacturer

Other names on FDA records

Zepf Medical Instruments Gmbh

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9045716). 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.