Manufacturer registered with FDA

USTOMED INSTRUMENTE GmbH & Co. KG

Tuttlingen, Germany. Lists 42 dental device types with FDA across 1 registered establishment.

FDA owner/operator10048936Manufacturer
Device types listed
42
Brands and models
1
510(k) clearances
0as applicant
Markets registered in
1United States
Establishments
1Germany

Devices listed with FDA

What USTOMED INSTRUMENTE GmbH & Co. KG currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Dental NeedleDZM · Class 1Dental needles & syringesMaker—2018
Dental Hand InstrumentsDZN · Class 1Dental hand instrumentsMaker—2018
Dental Diamond InstrumentDZP · Class 1Dental burs & diamondsMaker—2016
Mouth MirrorEAX · Class 1Dental hand instrumentsMaker—2018
Resin Impression Tray MaterialEBH · Class 1Impression traysMaker—2022
Air and/or Water Syringe UnitECB · Class 1Dental hand instrumentsMaker—2018
Orthodontic Band PusherECS · Class 1Dental hand instrumentsMaker—2018
Rubber Dam ClampEEF · Class 1Rubber dam systemsMaker—2018
Articulation Paper ForcepsEFK · Class 1Dental hand instrumentsMaker—2018
Dental Dressing ForcepsEFL · Class 1Dental hand instrumentsMaker
Splinter forceps
2022
Dental Surgical Tissue ScissorsEGN · Class 1Dental hand instrumentsMaker—2022
Preformed Impression TrayEHY · Class 1Impression traysMaker—2018
Oral Cavity EvacuatorEHZ · Class 1Suction & evacuation unitsMaker—2022
Irrigating (Dental) SyringeEIB · Class 1Dental hand instrumentsMaker—2022
Restorative and Impression Material SyringeEID · Class 1Dental hand instrumentsMaker—2018
Dental Retractor AccessoriesEIF · Class 1Dental hand instrumentsMaker—2022
Dental Wax CarverEIK · Class 1Dental hand instrumentsMaker—2018
Crown RemoverEIS · Class 1Dental hand instrumentsMaker—2018
Periodontic ProbeEIX · Class 1Dental hand instrumentsMaker—2018
Dental Plastic Filling InstrumentEIY · Class 1Dental hand instrumentsMaker—2018
Dental Instrument HandleEJB · Class 1Dental hand instrumentsMaker—2018
Rubber Dam FrameEJE · Class 1Rubber dam systemsMaker—2018
Rubber Dam Clamp ForcepsEJG · Class 1Rubber dam systemsMaker—2018
Dental BurEJL · Class 1Dental burs & diamondsMaker—2016
Operative PliersEJY · Class 1Dental hand instrumentsMaker—2018
Operative Dental ExcavatorEKC · Class 1Dental hand instrumentsMaker—2018
Operative Matrix Contouring InstrumentEKF · Class 1Dental hand instrumentsMaker—2022
Operative Dental Amalgam CarverEKH · Class 1Dental hand instrumentsMaker—2018
Operative Amalgam CarrierEKI · Class 1Dental hand instrumentsMaker—2018
Endodontic Pulp Canal Filling Material SpreaderEKK · Class 1Dental hand instrumentsMaker—2018
Endodontic Pulp Canal ReamerEKP · Class 1Endodontic filesMaker—2018
Endodontic Root Canal PluggerEKR · Class 1Dental hand instrumentsMaker—2018
Endodontic CuretteEKT · Class 1Dental hand instrumentsMaker—2018
Surgical Tooth Extractor ForcepsEMG · Class 1Dental hand instrumentsMaker—2018
Surgical Rongeur ForcepsEMH · Class 1Dental hand instrumentsMaker—2018
Dental Surgical ElevatorEMJ · Class 1Dental hand instrumentsMaker—2018
Dental Surgical CuretteEMK · Class 1Dental hand instrumentsMaker—2018
Surgical Bone ChiselEML · Class 1Dental hand instrumentsMaker—2018
Surgical Osteotome ChiselEMM · Class 1Dental hand instrumentsMaker—2018
Periodontic ScalerEMN · Class 1Dental hand instrumentsMaker—2018
Periodontic KnifeEMO · Class 1Dental hand instrumentsMaker—2018
Matrix RetainerJEP · Class 1Dental hand instrumentsMaker—2018

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
USTOMED INSTRUMENTE GMBH & CO. KGFDA reg. 3002808270Tuttlingen Baden-Wurttemberg, GermanyManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10048936). 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.