Dental Device Guide
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Registered with FDA

Spiggle & Theis Medizintechnik GmbH

OVERATH, Germany. Lists 1 dental device type with FDA across 1 registered establishment.

FDA owner/operator9050994Repacker / relabeler
Device types listed
1
Brands and models
1
510(k) clearances
0as applicant
Markets registered in
161,765 registrations outside the US
Establishments
1Germany

Registered in 16 markets

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

All markets
United States: 1 device types listedThailand: 1,003 registrationsCanada: 220 registrationsSouth Korea: 143 registrationsUnited Kingdom: 131 registrationsSaudi Arabia: 65 registrationsAustralia: 47 registrationsBrazil: 44 registrationsEuropean Union: 36 registrationsColombia: 19 registrationsPeru: 13 registrationsSerbia: 13 registrationsIsrael: 11 registrationsTaiwan: 9 registrationsChina: 7 registrationsHong Kong: 4 registrations
RegisteredHome: GermanyOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAListerSpiggle & Theis Medizintechnik GmbH1 device types—Below
ThailandThai FDAManufacturerSPIGGLE & THEIS MEDIZINTECHNIK GMBH1,003—Pure Global AI
CanadaHealth CanadaRegistration holderSPIGGLE & THEIS MEDIZINTECHNIK GMBH2202012–2026Pure Global AI
South KoreaMFDSManufacturerSpiggle & Theis Medizintechnik GmbHSpiggle&Theis Medizintechnik GmbH · Spiggle&Theis Medizintechnik · +21432010–2026Pure Global AI
United KingdomMHRAManufacturerSPIGGLE & THEIS Medizintechnik GmbH131—Pure Global AI
Saudi ArabiaSFDAManufacturerSpiggle & Theis Medizintechnik GmbH65—Pure Global AI
AustraliaTGAManufacturerSpiggle & Theis Medizintechnik GmbH472011–2026Pure Global AI
BrazilANVISAManufacturerSPIGGLE & THEIS MEDIZINTECHNIK GMBH442013–2026Pure Global AI
European UnionEUDAMEDManufacturerSPIGGLE & THEIS Medizintechnik GmbH36—Pure Global AI
ColombiaINVIMAManufacturerSPIGGLE & THEIS MEDIZINTECHNIK GMBH19—Pure Global AI
PeruDIGEMIDManufacturerSPIGGLE & THEIS MEDIZINTECHNIK GmbH132022–2025Pure Global AI
SerbiaALIMSManufacturerSpiggle & Theis Medizintechnik GmbH132023–2026Pure Global AI
IsraelAMARManufacturerSpiggle & Theis Medizintechnik GmbHSPIGGLE & THEIS MEDIZINTECHNIK GMBH11—Pure Global AI
TaiwanTFDAManufacturerSPIGGLE & THEIS MEDIZINTECHNIK GMBH92010–2024Pure Global AI
ChinaNMPARegistration holder德国宾格医疗技术股份有限公司Spiggle & Theis Medizintechnik GmbH德国宾格医疗技术股份有限公司Spiggle ＆ Theis Medizintechnik GmbH7—Pure Global AI
Hong KongMDDManufacturerSPIGGLE & THEIS Medizintechnik GmbH42026–2026Pure 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 Spiggle & Theis Medizintechnik GmbH currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Surgical Headlight LightEBA · Class 1Dental operating lightsLister
Light Surgical Headlight
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
SPIGGLE & THEIS MEDIZINTECHNIK GMBHFDA reg. 3002858762OVERATH North Rhine-Westphalia, GermanyRepacker / relabeler

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9050994). 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.