Temporary abutment Engaging Ø 4, 0
EUDAMEDFDA UDIClass IIb (EU MDR)
Identity
- Trade Name
- Temporary abutment Engaging Ø 4,0 EUDAMEDIPD FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- Cementing abutment ; Temporary abutment EUDAMEDTemporary abutment Engaging Ø 4,0 FDA UDI
- Model / Reference
- PC/PP EUDAMEDIPD/WB-PR-06 EUDAMEDPP FDA UDI
- Description
- Temporary abutment Engaging Ø 4,0 FDA UDI
Identifiers
- Catalog Number
- IPD/WB-PR-06 FDA UDI
- Primary DI / UDI-DI
- 08435566625183 EUDAMEDFDA UDI
- Basic UDI-DI
- 8435566601BL EUDAMED
- 510(k) Number
- K240570 FDA UDI
- FDA Product Code
- NHA FDA UDIPNP FDA UDI
- EMDN Code
- Q01020605 TEMPORARY DENTAL PROSTHESES EUDAMED
- GMDN Term
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Temporary dental crown/bridge
Temporary abutment Engaging Ø 4, 0 by Implant Protesis Dental 2004 S.l. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8435566601BL | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Implant Protesis Dental 2004 S.l.
- EUDAMED SRN
- ES-MF-000002195
Sources (2)
- EUDAMED 4fea8333-2184-464f-a197-91df33e04278 61 fields · synced Jul 12, 2026
- FDA UDI 4b679d52-e0b0-4a1e-b8d8-d278d46c6337 36 fields · synced May 30, 2026