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Axiom
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref PX34180Model Axiom BL Implant
by anthogyr
Identity
- Trade Name
- Axiom EUDAMEDFDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Device Name
- Axiom implant PX Ø3.4 x 18.0, Replacement of a missing tooth for placement of a dental restoration, not usable in the molar area, not recommended in D1 bone FDA UDI
- Model / Reference
- Axiom BL Implant EUDAMEDPX34180 EUDAMEDFDA UDI
- Description
- Axiom implant PX Ø3.4 x 18.0, Replacement of a missing tooth for placement of a dental restoration, not usable in the molar area, not recommended in D1 bone FDA UDI
Identifiers
- Catalog Number
- PX34180 FDA UDI
- Primary DI / UDI-DI
- 03663394002554 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 — 18 Millimeter FDA UDIOuter Diameter — 3.4 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 c7a435fd-5663-4771-9792-bfb13056061c 61 fields · synced Jun 8, 2026
- FDA UDI 09926790-786f-4567-9530-f2e69661d716 36 fields · synced May 30, 2026