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Axiom
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref OPST536-23Model Unitary Sterile Abutment/Base/Coping (Titanium)
by anthogyr
Identity
- Trade Name
- Axiom EUDAMEDFDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- STD. ANGULATED TITANIUM ABUT. Ø5 h3,5 23° Providing support for a permanent restoration. FDA UDI
- Model / Reference
- Unitary Sterile Abutment/Base/Coping (Titanium) EUDAMEDOPST536-23 EUDAMEDFDA UDI
- Description
- STD. ANGULATED TITANIUM ABUT. Ø5 h3,5 23° Providing support for a permanent restoration. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03663394002202 EUDAMEDFDA UDI
- Basic UDI-DI
- 36633940105QR EUDAMED
- FDA Product Code
- NHA FDA UDI
- EMDN Code
- P010299 ODONTOLOGICAL PROSTHESES - OTHER EUDAMED
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3630 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
- Outer Diameter — 5.0 Millimeter FDA UDIAngle — 23 degree 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 | 36633940105QR | 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 36895fce-796b-4ebc-99e1-1ea30676a199 61 fields · synced Oct 5, 2026
- FDA UDI 774c2c36-02c2-4b8e-92de-425d5f31d6e0 36 fields · synced May 30, 2026