Axiom®
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- AXIOM® FDA UDI
- Generic Name
- Dental power tool handpiece motorless component FDA UDI
- Device Name
- SPRAY NOZZLE FDA UDI
- Model / Reference
- 12430 EUDAMEDFDA UDIContra-angle accessory EUDAMED
- Description
- SPRAY NOZZLE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03663394170420 EUDAMEDFDA UDI
- Basic UDI-DI
- 36633940115QU EUDAMED
- FDA Product Code
- EGS FDA UDI
- EMDN Code
- Z12119099 VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Dental power tool handpiece motorless component FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4200 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
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
Category: Dental power tool handpiece motorless component
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 b55a9cdd-330a-4c2a-a363-bae8622ae51b 33 fields · synced Jun 19, 2026
- EUDAMED da2c9749-16b1-4962-9430-e35b229548bd 61 fields · synced Jun 19, 2026