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CAMLOG® SCREW-LINE Implant
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref K1046.3311
by ALTATEC GmbH
Identity
- Trade Name
- CAMLOG® SCREW-LINE Implant EUDAMEDCAMLOG® SCREW-LINE Implant, Promote® FDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Device Name
- CAMLOG® Screw-Line Implant EUDAMEDCAMLOG® SCREW-LINE Implant, Promote®, snap-in, d 3.3 mm, l 11 mm FDA UDI
- Model / Reference
- K1046.3311 EUDAMEDFDA UDI
- Description
- CAMLOG® SCREW-LINE Implant, Promote®, snap-in, d 3.3 mm, l 11 mm FDA UDI
Identifiers
- Catalog Number
- K1046.3311 FDA UDI
- Primary DI / UDI-DI
- 04099797004700 EUDAMEDE219K104633111 FDA UDI
- Basic UDI-DI
- 40997970000202000000000A5 EUDAMED
- Secondary DI
- E219K104633111 EUDAMED
- FDA Product Code
- DZE FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
- GMDN Term
- Screw endosteal dental implant, two-piece FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 3.3 Millimeter FDA UDILength — 11 Millimeter FDA UDI
CAMLOG® SCREW-LINE Implant 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 | 40997970000202000000000A5 | 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 16be7b3c-2807-447e-961e-5c80e5e66f0a 61 fields · synced Jul 29, 2026
- FDA UDI 42c02412-a71d-4f50-9798-8bde13a7de50 36 fields · synced May 29, 2026