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Dental Implant, ROOTT B, D 4.5 mm, L 16 mm.
EUDAMEDClass IIb (EU MDR)
Ref B4516Model Dental implant, ROOTT B
by Trate Ag
Identity
- Trade Name
- Dental Implant, ROOTT B, D 4.5 mm, L 16 mm. EUDAMED
- Model / Reference
- Dental implant, ROOTT B EUDAMEDB4516 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 17630053803879 EUDAMED
- Basic UDI-DI
- 76300538ROOTTBSX EUDAMED
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Dental Implant, ROOTT B, D 4.5 mm, L 16 mm. by Trate Ag — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 76300538ROOTTBSX | Class IIb | Active |
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Manufacturer
Sources (1)
- EUDAMED 2e2dbabb-5f6b-4501-a72b-c355e7a2e507 61 fields · synced Jun 19, 2026