Axiom
EUDAMEDFDA UDIClass IIb (EU MDR)
by anthogyr
Identity
- Trade Name
- Axiom EUDAMEDFDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- STD. TITANIUM ABUT. Ø4.0 h3/H4 Providing support for a permanent restoration. FDA UDI
- Model / Reference
- Unitary Sterile Abutment/Base/Coping (Titanium) EUDAMEDOPST434 EUDAMEDFDA UDI
- Description
- STD. TITANIUM ABUT. Ø4.0 h3/H4 Providing support for a permanent restoration. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03663394002059 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
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Outer Diameter — 4.0 Millimeter FDA UDIAngle — 0 degree FDA UDI
Category: Dental implant suprastructure, permanent, preformed
Axiom by anthogyr — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, permanent, preformed.
- SPARE CAST. SLEEVE FOR — SWEDEN & MARTINA INC · Class II
- HS/HG Prosthetic System — OSSTEM IMPLANT Co., Ltd. · Class II
- DESS dental smart solutions — TERRATS MEDICAL SL. · Class II
- Diamodent — Diamodent · Class II
- Cemented Abutment — POINTIMPLANT Co., Ltd. · Class II
- GS System — OSSTEM IMPLANT Co., Ltd. · Class II
- Temporary Abutment — Cybermed Inc. · Class II
- EZ Post — Megagen Implant Co. Ltd · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- anthogyr
- EUDAMED SRN
- FR-MF-000000602
Sources (2)
- EUDAMED 9d5ca753-35d3-419a-98e9-35ce918f7f29 61 fields · synced Oct 6, 2026
- FDA UDI ed0e7906-08a0-452c-b0fb-2f667bb6ea3a 36 fields · synced May 30, 2026