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Guide CAMLOG® SL Implant, Promote® plus
FDA UDIClass II (US FDA UDI)
by ALTATEC GmbH
Identity
- Trade Name
- Guide CAMLOG® SL Implant, Promote® plus FDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Device Name
- K1053.4316 Guide CAMLOG® SL Implant, Promote® plus d 4.3 mm, L 16.0 mm FDA UDI
- Model / Reference
- K1053.4316 FDA UDI
- Description
- K1053.4316 Guide CAMLOG® SL Implant, Promote® plus d 4.3 mm, L 16.0 mm FDA UDI
Identifiers
- Catalog Number
- K1053.4316 FDA UDI
- Primary DI / UDI-DI
- E219K105343161 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
- 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
Dimensions & Sizes
- Size
- Length — 16 Millimeter FDA UDILumen/Inner Diameter — 4.3 Millimeter FDA UDI
Category: Screw endosteal dental implant, two-piece
Guide CAMLOG® SL Implant, Promote® plus by ALTATEC GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 d520a513-0b9f-4ec4-b653-3d4fb66ba22a 36 fields · synced May 30, 2026