Dental Device Guide
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Manufacturer registered with FDA

Nopa Instruments Medizintechnik GmbH

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

FDA owner/operator8010704Contract manufacturer
Device types listed
23
Brands and models
27
510(k) clearances
0as applicant
Markets registered in
143,561 registrations outside the US
Establishments
1Germany

Registered in 14 markets

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

All markets
United States: 23 device types listedThailand: 2,374 registrationsSaudi Arabia: 596 registrationsSouth Korea: 263 registrationsEuropean Union: 119 registrationsPeru: 64 registrationsAustralia: 54 registrationsUnited Kingdom: 36 registrationsBrazil: 13 registrationsTaiwan: 13 registrationsColombia: 10 registrationsIsrael: 9 registrationsCosta Rica: 8 registrationsSerbia: 2 registrations
RegisteredHome: GermanyOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerNopa Instruments Medizintechnik GmbH23 device types—Below
ThailandThai FDAManufacturerNOPA INSTRUMENTS MEDIZINTECHNIK GMBH2,374—Pure Global AI
Saudi ArabiaSFDAManufacturernopa instruments Medizintechnik GmbH596—Pure Global AI
South KoreaMFDSManufacturernopa instruments Medizintechnik GmbHNOPA Instruments Medizintechnik GmbH · Nopa instruments Medizintechnik GmbH · +22631999–2026Pure Global AI
European UnionEUDAMEDManufacturernopa instruments Medizintechnik GmbH119—Pure Global AI
PeruDIGEMIDManufacturerNOPA INSTRUMENTS MEDIZINTECHNIK GmbHNOPA INSTRUMENTS MEDIZINTECHNIK GMBH · NOPA INSTRUMENTS MEDIZINTECHNIK642021–2026Pure Global AI
AustraliaTGAManufacturerNopa Instruments Medizintechnik GmbH542023–2024Pure Global AI
United KingdomMHRAManufacturernopa instruments Medizintechnik GmbH36—Pure Global AI
BrazilANVISAManufacturerNOPA INSTRUMENTS MEDIZINTECHNIK GMBH132019–2025Pure Global AI
TaiwanTFDAManufacturerNOPA INSTRUMENTS MEDIZINTECHNIK GMBH132005–2026Pure Global AI
ColombiaINVIMARegistration holderNOPA INSTRUMENTS MEDIZINTECHNIK GMBH10—Pure Global AI
IsraelAMARManufacturerNopa Instruments Medizintechnik GmbHNopa instruments Medizintechnik GmbH · nopa instruments Medizintechnik GmbH9—Pure Global AI
Costa RicaMinisterio de SaludManufacturernopa instruments Medizintechnik GmbH8—Pure Global AI
SerbiaALIMSManufacturernopa instruments Medizintechnik GmbH22026–2026Pure 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 Nopa Instruments Medizintechnik GmbH currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Dental Dressing ForcepsEFL · Class 1Dental hand instrumentsMaker
FORCEPS DRESSING DENTAL
1984
All Types RetractorEIG · Class 1Dental hand instrumentsMaker
RETRACTOR
2004
Dental Wax CarverEIK · Class 1Dental hand instrumentsMaker
CARVER
2004
Dental Instrument Depth GaugeEIL · Class 1Dental hand instrumentsMaker
BOLEY GAUGE
2004
Periodontic ProbeEIX · Class 1Dental hand instrumentsMaker
PROBE
2004
Dental Plastic Filling InstrumentEIY · Class 1Dental hand instrumentsMaker
PLASTIC FILLING INSTRUMENT
2004
Operative ExplorerEKB · Class 1Dental hand instrumentsMaker
EXPLORER OPERATIVE
2004
Operative Cutting InstrumentEKD · Class 1Dental hand instrumentsMaker
MARGIN TRIMMER
2004
Operative Matrix Contouring InstrumentEKF · Class 1Dental hand instrumentsMaker
CONTOURINGMATRIX
2004
Operative Dental Amalgam CarverEKH · Class 1Dental hand instrumentsMaker
LABROACH CARVER
2004
Operative BurnisherEKJ · Class 1Dental hand instrumentsMaker
BURNISHER
2004
Endodontic Pulp Canal Filling Material SpreaderEKK · Class 1Dental hand instrumentsMaker
SPREADER
2004
Endodontic Root Canal PluggerEKR · Class 1Dental hand instrumentsMaker
PLUGGERROOT CANAL
2004
Endodontic CuretteEKT · Class 1Dental hand instrumentsMaker
CURETTE
2004
Surgical Tooth Extractor ForcepsEMG · Class 1Dental hand instrumentsMaker
FORCEPS TOOTH
1984
Surgical Rongeur ForcepsEMH · Class 1Dental hand instrumentsMaker
RONGEUR
1984
Surgical Bone FileEMI · Class 1Dental hand instrumentsMaker
FILE BONE
1997
Dental Surgical ElevatorEMJ · Class 1Dental hand instrumentsMaker
ELEVATOR
2004
Dental Surgical CuretteEMK · Class 1Dental hand instrumentsMaker
CURETTE
2004
Surgical Bone ChiselEML · Class 1Dental hand instrumentsMaker
CHISEL BONE
1997
Periodontic HoeEMQ · Class 1Dental hand instrumentsMaker
HOE
2004
Matrix RetainerJEP · Class 1Dental hand instrumentsMaker
MATRIXRETAINER
2004
Orthodontic PlierJEX · Class 1Dental hand instrumentsMaker
PLIER
1984

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
NOPA INSTRUMENTS, MEDIZINTECHNIK GMBHFDA reg. 8010704TUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 8010704). 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.