FDA Registration Active 🇩🇪 Germany

MEDENTIKA GMBH

Reg #: 3008770646 · FEI: 3008770646 · Expires 2026
Products
4
Proprietary Names
27
Establishment Types
1
Classifications
4

Registration Details

Registration Name
MEDENTIKA GMBH
Registration Number
3008770646
FEI Number
3008770646
Status
Active
Expiry Year
2026
Initial Importer
No
Address
Hammweg 8-10
City
Huegelsheim Baden-Wurttemberg
Country
DE

Regulatory Submissions

510(k) Number
K260460

Owner / Operator

Firm Name
INSTITUT STRAUMANN AG
Operator Number
9005052
Address
PETER MERIAN-WEG 12
City
BASEL
State
CH-NOTA
Postal Code
CH-4002
Country
CH

US Agent

Business Name
Straumann USA, LLC
Contact Name
Jennifer M Jackson
Address
60 Minuteman Rd
City
Andover
State
MA
ZIP
01810
Country
US
Phone
978 7472509

Products

Device Name Product Code
Abutment, Implant, Dental, Endosseous NHA
Implant, Endosseous, Root-Form DZE
Dental Abutment Design Software For Dental Laboratory PNP
Accessories, Implant, Dental, Endosseous NDP

Proprietary Names

Medentika Custom Abutments Gold Hue Neodent Gold Hue Custom Abutments Medentiloc abutments Temporary abutments Abutment components HSL abutments (Castable gold abutments) Solid abutments (Prepable abutments) Medentibase abutments Standard abutments MINICONE Implant Preface abutment Multi-unit TitaniumBase & Multi-unit Titanium Cap Titanium base 2nd generation TI-Forms abutment Titanium base ASC Flex MedentiBase Titaniumbase abutment Medentika PreFace CAD/CAM Abutments Medentika TiBase CAD/CAM Abutments Medentika Abutment Screws Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments Multi-unit abutments and components Medentika TiBase 3.5 mm CAD/CAM Abutments Custom Abutment AS CARES® Advanced Bar CARES® Basic Bar CARES® Complex Bar Dental Implant Accesories

Establishment Types

Develop Specifications But Do Not Manufacture At This Facility