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Replace Select™ Tapered TiU WP 5.0x11.5mm
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 36109
Identity
- Trade Name
- Replace Select™ Tapered TiU WP 5.0x11.5mm EUDAMEDReplace Select™ FDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Device Name
- Tapered implants EUDAMEDReplace Select™ Tapered TiU WP 5.0x11.5mm FDA UDI
- Model / Reference
- 36109 EUDAMEDFDA UDI
- Description
- Replace Select™ Tapered TiU WP 5.0x11.5mm FDA UDI
Identifiers
- Catalog Number
- 36109 FDA UDI
- Primary DI / UDI-DI
- 07332747160345 EUDAMEDFDA UDI
- Basic UDI-DI
- 733274700000012875 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
- Sweden 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
Yes
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 — 11.500 Millimeter FDA UDIOuter Diameter — 5.000 Millimeter FDA UDI
Replace Select™ Tapered TiU WP 5.0x11.5mm by Nobel Biocare AB — 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 | 733274700000012875 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nobel Biocare AB
- EUDAMED SRN
- SE-MF-000000009
Sources (2)
- EUDAMED 6f554758-982d-4bd0-aebe-f6a41249bbfe 61 fields · synced Jun 19, 2026
- FDA UDI a035b892-50c4-4c56-b427-db5c03562ac9 37 fields · synced May 30, 2026