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CONELOG® Abutment screw
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref C4007.1600
by ALTATEC GmbH
Identity
- Trade Name
- CONELOG® Abutment screw EUDAMEDCONELOG® Vario SR abutment screw, FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- CONELOG® Vario SR abutment screw EUDAMEDC4007.1600 CONELOG® Vario SR abutment screw, hex, for CONELOG® Vario SR abutment, straight d 3.8/4.3 mm, thread M 1.6 FDA UDI
- Model / Reference
- C4007.1600 EUDAMEDFDA UDI
- Description
- C4007.1600 CONELOG® Vario SR abutment screw, hex, for CONELOG® Vario SR abutment, straight d 3.8/4.3 mm, thread M 1.6 FDA UDI
Identifiers
- Catalog Number
- C4007.1600 FDA UDI
- Primary DI / UDI-DI
- 04099797002973 EUDAMEDE219C400716001 FDA UDI
- Basic UDI-DI
- 40997970001504000000000GP EUDAMED
- Secondary DI
- E219C400716001 EUDAMED
- FDA Product Code
- NHA FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Sutures
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
CONELOG® Abutment screw by ALTATEC GmbH — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 40997970001504000000000GP | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- ALTATEC GmbH
- EUDAMED SRN
- DE-MF-000006230
Sources (2)
- EUDAMED 19020811-7996-4ca5-809e-c3fcad60019d 61 fields · synced May 31, 2026
- FDA UDI ff00f18f-f7f2-4068-9760-2b4779e529e6 35 fields · synced May 30, 2026