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Dental Implants - Externa Universal/ Universal Plus
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref IRPUCA4010
Identity
- Trade Name
- UNIVERSAL PLATFORM IMPLANT CA D:4.0 L:10 FDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Device Name
- DENTAL IMPLANTS - EXTERNA UNIVERSAL/ UNIVERSAL PLUS EUDAMED
- Model / Reference
- IRPUCA4010 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08435389815204 EUDAMEDFDA UDI
- Basic UDI-DI
- 84353898IMPL-EXTUNIVERZD 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
- Spain 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 10 Millimeter FDA UDIOuter Diameter — 4 Millimeter FDA UDI
Dental Implants - Externa Universal/ Universal Plus by B.t.i. Biotechnology Institute, S.l — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 84353898IMPL-EXTUNIVERZD | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- B.t.i. Biotechnology Institute, S.l
- EUDAMED SRN
- ES-MF-000001701
Sources (2)
- EUDAMED 2e0c38c7-3767-46af-bc30-27a4d3ad9bd4 61 fields · synced Jul 8, 2026
- FDA UDI 96e1300c-2284-4270-bca9-1bc7351c0e03 34 fields · synced May 30, 2026