Manufacturer registered with FDA

Tontarra Medizintechnik GmbH

WURMLINGEN, Germany. Lists 22 dental device types with FDA across 1 registered establishment.

FDA owner/operator9009570Contract manufacturer
Device types listed
22
Brands and models
14
510(k) clearances
0as applicant
Markets registered in
153,333 registrations outside the US
Establishments
1Germany

Registered in 15 markets

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

All markets
United States: 22 device types listedThailand: 2,821 registrationsUnited Kingdom: 227 registrationsSouth Korea: 96 registrationsPeru: 53 registrationsCanada: 37 registrationsAustralia: 30 registrationsBrazil: 18 registrationsCosta Rica: 18 registrationsColombia: 8 registrationsEgypt: 8 registrationsTaiwan: 7 registrationsIsrael: 5 registrationsChina: 3 registrationsEuropean Union: 2 registrations
RegisteredHome: GermanyOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerTontarra Medizintechnik GmbH22 device types—Below
ThailandThai FDAManufacturerTONTARRA MEDIZINTECHNIK GMBH2,821—Pure Global AI
United KingdomMHRAManufacturerTONTARRA Medizintechnik GmbH227—Pure Global AI
South KoreaMFDSManufacturerTONTARRA Medizintechnik GmbHTontarra Medizintechnik GmbH · TONTARRA MEDIZINTECHNIK GMBH962004–2026Pure Global AI
PeruDIGEMIDManufacturerTONTARRA MEDIZINTECHNIK GmbHTONTARRA MEDIZINTECHNIK GMBH532019–2026Pure Global AI
CanadaHealth CanadaRegistration holderTONTARRA MEDIZINTECHNIK GMBH372021–2026Pure Global AI
AustraliaTGAManufacturerTontarra Medizintechnik GmbH302006–2026Pure Global AI
BrazilANVISAManufacturerTONTARRA MEDIZINTECHNIK GMBH182010–2020Pure Global AI
Costa RicaMinisterio de SaludManufacturerTONTARRA Medizintechnik GmbHTontarra Medizintechnik18—Pure Global AI
ColombiaINVIMAManufacturerTONTARRA MEDIZINTECHNIK GMBH8—Pure Global AI
EgyptEDAManufacturerTONTARRA Medizintechnik GmbH,82026–2026Pure Global AI
TaiwanTFDAManufacturerTONTARRA MEDIZINTECHNIK GMBH72005–2024Pure Global AI
IsraelAMARManufacturerTontarra Medizintechnik GmbH5—Pure Global AI
ChinaNMPARegistration holder通特纳医疗器械有限公司Tontarra Medizintechnik GmbH3—Pure Global AI
European UnionEUDAMEDManufacturerTontarra Medizintechnik GmbH2—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 Tontarra Medizintechnik GmbH currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Cartridge SyringeEJI · Class 2Dental needles & syringesMaker—2023
Intraoral Dental DrillDZA · Class 1Surgical drills & motorsMaker—2018
Dental Hand InstrumentsDZN · Class 1Dental hand instrumentsMaker—2018
Articulation Paper ForcepsEFK · Class 1Dental hand instrumentsMaker—2019
Dental Dressing ForcepsEFL · Class 1Dental hand instrumentsMaker
DENTALFORCEPS
2002
Dental Surgical Tissue ScissorsEGN · Class 1Dental hand instrumentsMaker—2016
Dental Retractor AccessoriesEIF · Class 1Dental hand instrumentsMaker—2018
All Types RetractorEIG · Class 1Dental hand instrumentsMaker
HOEN RETRACTOR
1994
Collar and Crown ScissorsEIR · Class 1Dental hand instrumentsMaker—2016
Periodontic ProbeEIX · Class 1Dental hand instrumentsMaker
PERIODONTICPROBE
2002
Operative PliersEJY · Class 1Dental hand instrumentsMaker
Pliers, operative
2002
Operative ExplorerEKB · Class 1Dental hand instrumentsMaker
Explorer, Operative
2012
Surgical HemostatEMD · Class 1Dental hand instrumentsMaker—2018
Surgical Biopsy PunchEME · Class 1Dental hand instrumentsMaker—1997
Surgical Tooth Extractor ForcepsEMG · Class 1Dental hand instrumentsMaker
SURGICAL TOOTH EXTRACTOR FORCEPS
2002
Surgical Rongeur ForcepsEMH · Class 1Dental hand instrumentsMaker—1994
Surgical Bone FileEMI · Class 1Dental hand instrumentsMaker
File, Bone, Surgical
2012
Dental Surgical ElevatorEMJ · Class 1Dental hand instrumentsMaker
Elevator, Surgical, Dental
2012
Surgical Osteotome ChiselEMM · Class 1Dental hand instrumentsMaker
Osteotomes
2020
Periodontic ScalerEMN · Class 1Dental hand instrumentsMaker
Periodontic Scaler
2021
Periodontic FileEMR · Class 1Dental hand instrumentsMaker
20-0406
2022
Orthodontic PlierJEX · Class 1Dental hand instrumentsMaker
Plier
2019

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
TONTARRA MEDIZINTECHNIK GMBHFDA reg. 9680515WURMLINGEN Baden-Wurttemberg, GermanyContract manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9009570). 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.