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Dental Implants - Interna Narrow
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref IIPEXCA4710
Identity
- Trade Name
- INTERNA IMPLANT, NARROW PLATFORM, CORE-X® CA D:4.75 L:10 FDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Device Name
- DENTAL IMPLANTS - INTERNA NARROW EUDAMED
- Model / Reference
- IIPEXCA4710 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- IIPEXCA4710 FDA UDI
- Primary DI / UDI-DI
- 08435389826538 EUDAMEDFDA UDI
- Basic UDI-DI
- 84353898IMPL-INTNARROWRL 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
Yes
FDA UDI
MR Conditional FDA UDI
Dental Implants - Interna Narrow by B.t.i. Biotechnology Institute, S.l — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 84353898IMPL-INTNARROWRL | Class IIb | Unknown |
| 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 24e1c02c-ba27-445a-ace2-459c7e7af4bc 61 fields · synced Jun 12, 2026
- FDA UDI 63001c70-bbc4-4c6e-9de5-3170f43149fd 33 fields · synced May 30, 2026