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CAMLOG® SCREW-LINE Implant, Promote® plus
FDA UDIClass II (US FDA UDI)
by ALTATEC GmbH
Identity
- Trade Name
- CAMLOG® SCREW-LINE Implant, Promote® plus FDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Device Name
- K1054.5013 CAMLOG® SCREW-LINE Implant, Promote® plus, d=5mm, l=13mm FDA UDI
- Model / Reference
- K1054.5013 FDA UDI
- Description
- K1054.5013 CAMLOG® SCREW-LINE Implant, Promote® plus, d=5mm, l=13mm FDA UDI
Identifiers
- Catalog Number
- K1054.5013 FDA UDI
- Primary DI / UDI-DI
- E219K105450131 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Screw endosteal dental implant, two-piece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
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
- Length — 13 Millimeter FDA UDILumen/Inner Diameter — 5 Millimeter FDA UDI
CAMLOG® SCREW-LINE Implant, Promote® plus by ALTATEC GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- ALTATEC GmbH
Sources (1)
- FDA UDI 420cd85b-7829-4067-b9e6-b6011dfb6915 37 fields · synced May 31, 2026