FDA Registration
Active
🇩🇪 Germany
Medentika GmbH
Reg #: 3026444199
·
FEI: 3026444199
·
Expires 2026
Products
4
Proprietary Names
27
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Medentika GmbH
- Registration Number
- 3026444199
- FEI Number
- 3026444199
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Im Interkom 32
- City
- Calw Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K142167
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 | 2023-10-31 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2007-06-29 |
| 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 |
Proprietary Names
Medentiloc abutments
Temporary abutments
Abutment components
HSL abutments (Castable gold abutments)
Solid abutments (Prepable abutments)
Medentibase abutments
Standard abutments
Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments
Dental Implant Accesories
MINICONE Implant
Medentika Custom Abutments Gold Hue
Neodent Gold Hue Custom Abutments
Multi-unit abutments and components
CARES® Advanced Bar
CARES® Basic Bar
CARES® Complex Bar
Custom Abutment AS
Medentika PreFace CAD/CAM Abutments
Medentika TiBase CAD/CAM Abutments
Medentika Abutment Screws
Medentika TiBase 3.5 mm CAD/CAM Abutments
Preface abutment
Multi-unit TitaniumBase & Multi-unit Titanium Cap
Titanium base 2nd generation
TI-Forms abutment
Titanium base ASC Flex
MedentiBase Titaniumbase abutment
Establishment Types
Manufacture Medical Device