Temporary Abutment
EUDAMEDFDA UDIClass IIb (EU MDR)
Identity
- Trade Name
- Temporary Abutment EUDAMEDTemporary abutment Non-Engaging Ø 3,3 EUDAMEDTemporary abutment Non-Engaging Ø 3.3 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 3,3 FDA UDI
- Model / Reference
- PC/PP EUDAMEDIPD/RA-PN-06 EUDAMEDIPD/RA-PW-07 EUDAMEDIPD/RA-PW-06 EUDAMEDIPD/DB-PN-07 EUDAMEDIPD/RA-PN-07 EUDAMEDPP FDA UDI
- Description
- Temporary abutment Non-Engaging Ø 3,3 FDA UDI
Identifiers
- Catalog Number
- IPD/DB-PN-07 FDA UDI
- Primary DI / UDI-DI
- 08435566626654 EUDAMED08435566626661 EUDAMED08435566626678 EUDAMED08435566609237 EUDAMEDFDA UDI08435566626364 EUDAMED
- Basic UDI-DI
- 8435566601BL EUDAMED
- 510(k) Number
- K231413 FDA UDI
- FDA Product Code
- PNP FDA UDINHA 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 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 (6)
- EUDAMED 161eff8c-244b-4b7a-98b1-16f72bb50517 61 fields · synced Oct 6, 2026
- EUDAMED 0d3167a5-f0ae-497c-b3f2-7b80c3acc376 61 fields · synced May 17, 2026
- EUDAMED bb19de3a-55e8-47fe-a189-f51eeff1f67a 61 fields · synced May 17, 2026
- EUDAMED 113a1a7d-4883-447c-a19f-e68131a4c6da 61 fields · synced May 18, 2026
- EUDAMED e91f286b-060d-4c25-803d-650c5e52b15b 61 fields · synced May 18, 2026
- FDA UDI 6da66255-3b2a-40e1-b644-b099c87b243a 36 fields · synced May 30, 2026