Dental Device Guide
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Manufacturer registered with FDA

YETI Dentalprodukte GmbH

Engen, Germany. Lists 5 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator10034246ManufacturerRepacker / relabelerSpecification developer
Device types listed
5
Brands and models
5
510(k) clearances
12018–2018
Markets registered in
844 registrations outside the US
Establishments
1Germany
2018: 120102020

510(k) clearances per year, 2007–2026

Registered in 8 markets

Where regulators' registries name YETI Dentalprodukte GmbH as the manufacturer or the registration holder of a device.

All markets
United States: 5 device types listedSaudi Arabia: 17 registrationsSouth Korea: 10 registrationsEuropean Union: 8 registrationsBrazil: 5 registrationsUnited Kingdom: 2 registrationsChina: 1 registrationsTaiwan: 1 registrations
RegisteredHome: GermanyOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerYETI Dentalprodukte GmbH1 clearances2018–2018Below
Saudi ArabiaSFDAManufacturerYETI Dentalprodukte GmbH17—Pure Global AI
South KoreaMFDSManufacturerYETI Dentalprodukte GmbHYeti Dentalprodukte GmbH102001–2025Pure Global AI
European UnionEUDAMEDManufacturerYeti Dentalprodukte GmbH8—Pure Global AI
BrazilANVISAManufacturerYETI DENTALPRODUKTE GMBH52020–2026Pure Global AI
United KingdomMHRAManufacturerYETI Dentalprodukte GmbH2—Pure Global AI
ChinaNMPARegistration holder德国耶体齿科材料有限公司Yeti Dentalprodukte GmbH1—Pure Global AI
TaiwanTFDAManufacturerYETI DENTALPRODUKTE GMBH12005–2005Pure 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 YETI Dentalprodukte 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
lot
2010
Resin Impression Tray MaterialEBH · Class 1Impression traysLister—2017
Intraoral Dental WaxEGD · Class 1—Maker—2017
Porcelain PowderEIH · Class 2Dental ceramics & zirconiaMaker—2019
Base Metal AlloyEJH · Class 2Dental alloysMaker
Lot (Solder) UniversalSolibond C plusSolibond NSolidur CoCr
2010

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names YETI Dentalprodukte GmbH as the applicant.

Decided510(k)DeviceDevice type
15 Nov 2018K173971K2 Zirkon Blank white classic; K2 Zirkon Blank translucent; K2 Blanks extreme translucentEIH Porcelain Powder

Registered establishments

EstablishmentLocationWhat it does
YETI DENTALPRODUKTE GMBHFDA reg. 3006235664Engen Baden-Wurttemberg, GermanyManufacturer, Repacker / relabeler, Specification developer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10034246). 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.