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Axiom
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref XT58100Model Axiom BL Implant
by anthogyr
Identity
- Trade Name
- Axiom EUDAMEDAXIOM® FDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Device Name
- AXIOM IMPLANT X3 Ø5.8 X 10.0 FDA UDI
- Model / Reference
- Axiom BL Implant EUDAMEDXT58100 EUDAMEDFDA UDI
- Description
- AXIOM IMPLANT X3 Ø5.8 X 10.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03663394483728 EUDAMEDFDA UDI
- Basic UDI-DI
- 36633940001QC 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
- France 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
Dimensions & Sizes
- Size
- Length — 10 Millimeter FDA UDIOuter Diameter — 5.8 Millimeter FDA UDI
Axiom by anthogyr — 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 | 36633940001QC | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- anthogyr
- EUDAMED SRN
- FR-MF-000000602
Sources (2)
- EUDAMED f0501a40-2d20-4b80-9e25-b25f1da0d198 61 fields · synced Jul 13, 2026
- FDA UDI 9d8c22ba-ea4f-4596-98ce-37d6af6ae180 34 fields · synced May 30, 2026