Dental Device Guide
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Manufacturer registered with FDA

Tekno-Medical Optik-Chirurgie GmbH

Tuttlingen, Germany. Lists 23 dental device types with FDA across 1 registered establishment.

FDA owner/operator10027774ManufacturerRepacker / relabeler
Device types listed
23
Brands and models
0
510(k) clearances
0as applicant
Markets registered in
133,480 registrations outside the US
Establishments
1Germany

Registered in 13 markets

Where regulators' registries name Tekno-Medical Optik-Chirurgie GmbH as the manufacturer or the registration holder of a device.

All markets
United States: 23 device types listedThailand: 3,020 registrationsCosta Rica: 187 registrationsSouth Korea: 129 registrationsAustralia: 47 registrationsPeru: 33 registrationsColombia: 25 registrationsTaiwan: 16 registrationsBrazil: 14 registrationsChina: 6 registrationsSaudi Arabia: 1 registrationsSerbia: 1 registrationsTanzania: 1 registrations
RegisteredHome: GermanyOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerTekno-Medical Optik-Chirurgie GmbH23 device types—Below
ThailandThai FDAManufacturerTEKNO-MEDICAL OPTIK-CHIRURGIE GMBH3,020—Pure Global AI
Costa RicaMinisterio de SaludManufacturerTekno-Medical Optik-Chirurgie GmbH187—Pure Global AI
South KoreaMFDSManufacturerTekno-Medical Optik-Chirurgie GmbHTEKNO-MEDICAL Optik-Chirurgie GmbH · Tekno-Medical Optik Chirurgie · +21292006–2026Pure Global AI
AustraliaTGAManufacturerTekno-Medical Optik-Chirurgie GmbH472014–2026Pure Global AI
PeruDIGEMIDManufacturerTEKNO-MEDICAL OPTIK-CHIRURGIE GmbHTEKNO MEDICAL OPTIK-CHIRURGIE GmbH · TEKNO - MEDICAL OPTIK - CHIRURGIE GmbH · +2332014–2025Pure Global AI
ColombiaINVIMARegistration holderTEKNO MEDICAL OPTIK CHIRURGIE GMBHTEKNO-MEDICAL OPTIK-CHIRURGIE GMBH25—Pure Global AI
TaiwanTFDAManufacturerTEKNO-MEDICAL OPTIK-CHIRURGIE GMBH.TEKNO MEDICAL OPTIK-CHIRURGIE GMBH · TEKNO-MEDICAL OPTIK-CHIRURGIE GMBH · +1162011–2019Pure Global AI
BrazilANVISAManufacturerTEKNO-MEDICAL OPTIK-CHIRURGIE GMBH142024–2026Pure Global AI
ChinaNMPARegistration holder泰可诺医学光学外科有限公司Tekno-Medical Optik-Chirurgie GmbH6—Pure Global AI
Saudi ArabiaSFDAManufacturerTekno-Medical Optik-Chirurgie GmbH1—Pure Global AI
SerbiaALIMSManufacturerTekno-Medical Optik-Chirurgie GmbH12022–2022Pure Global AI
TanzaniaTMDAManufacturerTekno-Medical Optik Chirurgie GmbH12023–2023Pure 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 Tekno-Medical Optik-Chirurgie GmbH currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Mouth MirrorEAX · Class 1Dental hand instrumentsMaker—2008
Surgical Headlight LightEBA · Class 1Dental operating lightsLister—2010
Orthodontic Ligature Tucking InstrumentECP · Class 1Dental hand instrumentsMaker—2022
Orthodontic Band PusherECS · Class 1Dental hand instrumentsMaker—2008
Articulation Paper ForcepsEFK · Class 1Dental hand instrumentsMaker—2017
Dental Dressing ForcepsEFL · Class 1Dental hand instrumentsMaker—2008
Dental Surgical Tissue ScissorsEGN · Class 1Dental hand instrumentsMaker—2008
Oral Cavity EvacuatorEHZ · Class 1Suction & evacuation unitsMaker—2016
Irrigating Endodontic Periodontic SyringeEIC · Class 1Dental hand instrumentsMaker—2008
All Types RetractorEIG · Class 1Dental hand instrumentsMaker—2013
Collar and Crown ScissorsEIR · Class 1Dental hand instrumentsMaker—2008
Rubber Dam FrameEJE · Class 1Rubber dam systemsMaker—2008
Rubber Dam Clamp ForcepsEJG · Class 1Rubber dam systemsMaker—2008
Operative ExplorerEKB · Class 1Dental hand instrumentsMaker—2014
Operative Dental ExcavatorEKC · Class 1Dental hand instrumentsMaker—2008
Surgical Tooth Extractor ForcepsEMG · Class 1Dental hand instrumentsMaker—2008
Surgical Rongeur ForcepsEMH · Class 1Dental hand instrumentsMaker—2008
Surgical Bone FileEMI · Class 1Dental hand instrumentsMaker—2008
Dental Surgical ElevatorEMJ · Class 1Dental hand instrumentsMaker—2008
Dental Surgical CuretteEMK · Class 1Dental hand instrumentsMaker—2008
Periodontic ScalerEMN · Class 1Dental hand instrumentsMaker—2008
Matrix RetainerJEP · Class 1Dental hand instrumentsMaker—2008
Orthodontic PlierJEX · Class 1Dental hand instrumentsLister—2008

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
TEKNO MEDICAL OPTIK-CHIRURGIE GMBHFDA reg. 9611503TUTTLINGEN-Nendingen Baden-Wurttemberg, GermanyManufacturer, Repacker / relabeler

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10027774). 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.