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Temporary abutment Non-Engaging Ø 4, 5
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref IPD/LB-PR-07Model PC/PP
Identity
- Trade Name
- Temporary abutment Non-Engaging Ø 4,5 EUDAMEDIPD FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- Cementing abutment ; Temporary abutment EUDAMEDTemporary abutment Non-Engaging Ø 4,5 FDA UDI
- Model / Reference
- PC/PP EUDAMEDIPD/LB-PR-07 EUDAMEDPP FDA UDI
- Description
- Temporary abutment Non-Engaging Ø 4,5 FDA UDI
Identifiers
- Catalog Number
- IPD/LB-PR-07 FDA UDI
- Primary DI / UDI-DI
- 08435566617881 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Temporary dental crown/bridge
Temporary abutment Non-Engaging Ø 4, 5 by Implant Protesis Dental 2004 S.l. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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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 | 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 af251d5b-0d07-40b1-b8cd-24722740535f 61 fields · synced Jul 31, 2026
- FDA UDI a3a933a2-b06a-4b2e-987a-e5522108a52b 36 fields · synced May 30, 2026