Dental Device Guide
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Manufacturer registered with FDA

SUBAN Instruments Germany GmbH

TUTTLINGEN, Germany. Lists 14 dental device types with FDA across 1 registered establishment.

FDA owner/operator8010665Contract manufacturer
Device types listed
14
Brands and models
2
510(k) clearances
0as applicant
Markets registered in
49 registrations outside the US
Establishments
1Germany

Registered in 4 markets

Where regulators' registries name SUBAN Instruments Germany GmbH as the manufacturer or the registration holder of a device.

All markets
United States: 14 device types listedColombia: 6 registrationsTaiwan: 2 registrationsSouth Korea: 1 registrations
RegisteredHome: GermanyOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerSUBAN Instruments Germany GmbH14 device types—Below
ColombiaINVIMAManufacturerSUBAN INSTRUMENTS GERMANY GMBH6—Pure Global AI
TaiwanTFDAManufacturerSUBAN INSTRUMENTS GERMANY GMBH22017–2021Pure Global AI
South KoreaMFDSManufacturerSUBAN Instruments Germany GmbH11998–1998Pure 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 SUBAN Instruments Germany GmbH currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Dental Hand InstrumentsDZN · Class 1Dental hand instrumentsMaker
RL-251-062WL 01-0434
2019
Dental Dressing ForcepsEFL · Class 1Dental hand instrumentsMaker—1999
Dental Surgical Tissue ScissorsEGN · Class 1Dental hand instrumentsMaker—2013
All Types RetractorEIG · Class 1Dental hand instrumentsMaker—2019
Collar and Crown ScissorsEIR · Class 1Dental hand instrumentsMaker—1999
Crown RemoverEIS · Class 1Dental hand instrumentsMaker—2013
Operative PliersEJY · Class 1Dental hand instrumentsMaker—1992
Endodontic CuretteEKT · Class 1Dental hand instrumentsMaker—2019
Surgical HemostatEMD · Class 1Dental hand instrumentsMaker—1992
Surgical Tooth Extractor ForcepsEMG · Class 1Dental hand instrumentsMaker—2005
Dental Surgical ElevatorEMJ · Class 1Dental hand instrumentsMaker—1992
Surgical Bone ChiselEML · Class 1Dental hand instrumentsMaker—1999
Surgical Osteotome ChiselEMM · Class 1Dental hand instrumentsMaker—2013
Orthodontic PlierJEX · Class 1Dental hand instrumentsMaker—1999

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
SUBAN Instruments Germany GmbHFDA reg. 8010665TUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 8010665). 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.