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CAMLOG® Gold-plastic Abutment
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref K2246.4300
by ALTATEC GmbH
Identity
- Trade Name
- CAMLOG® Gold-plastic Abutment EUDAMEDCAMLOG® Gold-plastic abutment FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- CAMLOG® Gold-plastic abutment EUDAMEDK2246.4300 CAMLOG® Gold-plastic abutment, d 4.3 mm FDA UDI
- Model / Reference
- K2246.4300 EUDAMEDFDA UDI
- Description
- K2246.4300 CAMLOG® Gold-plastic abutment, d 4.3 mm FDA UDI
Identifiers
- Catalog Number
- K2246.4300 FDA UDI
- Primary DI / UDI-DI
- 04099797017717 EUDAMEDE219K224643001 FDA UDI
- Basic UDI-DI
- 409979700011100000000009E EUDAMED
- Secondary DI
- E219K224643001 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® Gold-plastic 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 | 409979700011100000000009E | 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 a0b1b9f5-68e4-44d3-b201-e2f8b5772514 61 fields · synced Jul 10, 2026
- FDA UDI af0cd5a8-2499-4eb4-9ec5-cedcabc7267d 35 fields · synced May 30, 2026