Dental Device Guide
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Manufacturer registered with FDA

Asanus Medizintechnik GmbH

IRNDORF, Germany. Lists 13 dental device types with FDA across 1 registered establishment.

FDA owner/operator9040367ManufacturerRepacker / relabelerSpecification developer
Device types listed
13
Brands and models
13
510(k) clearances
0as applicant
Markets registered in
1110,227 registrations outside the US
Establishments
1Germany

Registered in 11 markets

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

All markets
United States: 13 device types listedThailand: 8,542 registrationsSaudi Arabia: 1,438 registrationsSerbia: 131 registrationsSouth Korea: 70 registrationsPeru: 29 registrationsAustralia: 8 registrationsIsrael: 4 registrationsTaiwan: 3 registrationsBrazil: 1 registrationsColombia: 1 registrations
RegisteredHome: GermanyOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerAsanus Medizintechnik GmbH13 device types—Below
ThailandThai FDAManufacturerASANUS MEDIZINTECHNIK GMBHASANUS Medizintechnik GmbH8,542—Pure Global AI
Saudi ArabiaSFDAManufacturerASANUS Medizintechnik GmbH1,438—Pure Global AI
SerbiaALIMSManufacturerASANUS Medizintechnik GmbH1312023–2024Pure Global AI
South KoreaMFDSManufacturerASANUS Medizintechnik GmbHAsanus Medizintechnik GmbH · Asanus Medizintechnik · +1702009–2026Pure Global AI
PeruDIGEMIDManufacturerASANUS MEDIZINTECHNIK GmbH292024–2025Pure Global AI
AustraliaTGAManufacturerAsanus Medizintechnik GmbH82025–2026Pure Global AI
IsraelAMARManufacturerASANUS Medizintechnik GmbHASANUS medizintechnik GmbH4—Pure Global AI
TaiwanTFDAManufacturerASANUS MEDIZINTECHNIK GMBH32010–2019Pure Global AI
BrazilANVISAManufacturerASANUS MEDIZINTECHNIK GMBH12013–2013Pure Global AI
ColombiaINVIMAManufacturerASANUS 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 Asanus Medizintechnik GmbH currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Orthodontic Material BandDYO · Class 1Orthodontic wires & bandsMaker
ASANUS
2001
Dental Hand InstrumentsDZN · Class 1Dental hand instrumentsMaker
ASANUS
2023
Mouth MirrorEAX · Class 1Dental hand instrumentsMaker
ASANUS
2022
Dental Dressing ForcepsEFL · Class 1Dental hand instrumentsMaker
ASANUS
2022
Dental Surgical Tissue ScissorsEGN · Class 1Dental hand instrumentsMaker
ASANUS
2023
All Types RetractorEIG · Class 1Dental hand instrumentsMaker
ASANUS
2000
Operative PliersEJY · Class 1Dental hand instrumentsMaker
ASANUS
2001
Surgical HemostatEMD · Class 1Dental hand instrumentsMaker
ASANUS
2000
Surgical Tooth Extractor ForcepsEMG · Class 1Dental hand instrumentsMaker
ASANUS
2023
Surgical Rongeur ForcepsEMH · Class 1Dental hand instrumentsMaker
ASANUS
2022
Dental Surgical ElevatorEMJ · Class 1Dental hand instrumentsMaker
ASANUS
2023
Surgical Bone ChiselEML · Class 1Dental hand instrumentsMaker
ASANUS
2022
Surgical Osteotome ChiselEMM · Class 1Dental hand instrumentsMaker
ASANUS
2022

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

EstablishmentLocationWhat it does
ASANUS MEDIZINTECHNIK GMBHFDA reg. 9616250NEUHAUSEN OBECK Baden-Wurttemberg, GermanyManufacturer, Repacker / relabeler, Specification developer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9040367). 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.