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Ti Screw Ø 3, 4/4, 1/5, 0
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref IPD/BA-TR-00Model TT
Identity
- Trade Name
- Ti Screw Ø 3,4/4,1/5,0 EUDAMEDIPD FDA UDI
- Generic Name
- Dental prosthesis/implant abutment screw FDA UDI
- Device Name
- Titanium screws EUDAMEDTi Screw Ø 3,4/4,1/5,0 FDA UDI
- Model / Reference
- TT EUDAMEDFDA UDIIPD/BA-TR-00 EUDAMED
- Description
- Ti Screw Ø 3,4/4,1/5,0 FDA UDI
Identifiers
- Catalog Number
- IPD/BA-TR-00 FDA UDI
- Primary DI / UDI-DI
- 08435566604904 EUDAMEDFDA UDI
- Basic UDI-DI
- 8435566610BM EUDAMED
- 510(k) Number
- K240570 FDA UDI
- FDA Product Code
- NHA FDA UDIPNP FDA UDI
- EMDN Code
- Q010280 PROSTHETIC DENTISTRY DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Dental prosthesis/implant abutment screw 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
Ti Screw Ø 3, 4/4, 1/5, 0 by Implant Protesis Dental 2004 S.l. — 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 | 8435566610BM | 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 61e87079-00fc-4f30-a09c-30e6177a9b0a 61 fields · synced Jul 11, 2026
- FDA UDI 3d4c49ea-e8cd-4111-8bd4-e2bd9f1a2638 36 fields · synced May 29, 2026