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CAMLOG® Universal Abutment
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref K2211.4300
by ALTATEC GmbH
Identity
- Trade Name
- CAMLOG® Universal Abutment EUDAMEDCAMLOG® Universal abutment FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- CAMLOG® Standard abutment EUDAMEDK2211.4300 CAMLOG® Universal abutment, d 4.3 mm FDA UDI
- Model / Reference
- K2211.4300 EUDAMEDFDA UDI
- Description
- K2211.4300 CAMLOG® Universal abutment, d 4.3 mm FDA UDI
Identifiers
- Catalog Number
- K2211.4300 FDA UDI
- Primary DI / UDI-DI
- 04099797006322 EUDAMEDE219K221143001 FDA UDI
- Basic UDI-DI
- 40997970001107000000000ES EUDAMED
- Secondary DI
- E219K221143001 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
CAMLOG® Universal Abutment 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 | 40997970001107000000000ES | 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 fd0f6811-1155-4314-84c1-c814edda1eed 61 fields · synced Jul 10, 2026
- FDA UDI f10d1d3f-ed5a-42b4-a72c-140f8a49da7e 35 fields · synced May 30, 2026