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
- [email protected]
- Phone
- 978 7472509
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2026-05-14 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2023-10-31 |
| Dental Abutment Design Software For Dental Laboratory | PNP | Class 2 | Dental | No | 2025-09-04 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2007-06-29 |
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