FDA Registration
Active
🇩🇪 Germany
SICAT GMBH & CO. KG
Reg #: 3006098230
·
FEI: 3006098230
·
Expires 2026
Products
7
Proprietary Names
13
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- SICAT GMBH & CO. KG
- Registration Number
- 3006098230
- FEI Number
- 3006098230
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Friesdorfer Strasse 131-135
- City
- BONN North Rhine-Westphalia
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K152661
Owner / Operator
- Firm Name
- SICAT GMBH & CO. KG
- Operator Number
- 9087842
- Address
- Friesdorfer Strasse 131-135, --
- City
- BONN
- State
- North Rhine-Westphalia
- Postal Code
- 53175
- Country
- DE
- Correspondent
- Manfred - Breuer
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 2018-07-06 |
| Device, Jaw Tracking, For Monitoring Jaw Positions | NFS | Class 1 | Dental | No | 2013-10-22 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2015-12-17 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2018-05-17 |
| Device, Jaw Repositioning | LQZ | Class 2 | Dental | No | 2016-04-04 |
| Device, Anti-Snoring | LRK | Class 2 | Dental | No | 2016-04-04 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2007-05-18 |
Proprietary Names
Endo Dental Bur
Paraocclusal Attachment
Fusion Bite
Fusion Bite Adapter
SICAT AIR
SICAT ACCESSGUIDE
SICAT IMPLANT
SICAT OPTISLEEP
SICAT FUNCTION
SICAT ENDO
SICAT SURGICAL GUIDE
StecoGuide
SICAT BITE PLATE
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device