Identity
- Trade Name
- FIRST DRILL EUDAMEDAXIOM® FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, reusable FDA UDI
- Device Name
- Guide sleeve Ø2.0 FDA UDI
- Model / Reference
- OPGS20-ET EUDAMEDFDA UDISleeve EUDAMED
- Description
- Guide sleeve Ø2.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03663394484282 EUDAMEDFDA UDI
- Basic UDI-DI
- 36633940091R7 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Dental implant suprastructure, temporary, preformed, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
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
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Outer Diameter — 2 Millimeter FDA UDI
Category: Dental implant suprastructure, temporary, preformed, reusable
Axiom® by Etablissements Anthogyr — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Etablissements Anthogyr
Sources (2)
- FDA UDI 08f1d8e5-a7e9-472d-b411-04c39218a5a4 34 fields · synced Jul 8, 2026
- EUDAMED bf639f42-d5ab-404e-a895-18a61b2c63da 61 fields · synced Jun 18, 2026