Identity
- Trade Name
- AxioModelling Wax 225g 12 sheets FDA UDI
- Generic Name
- Denture trial fabrication wax FDA UDI
- Model / Reference
- 28018 FDA UDI
Identifiers
- Primary DI / UDI-DI
- D161280180 FDA UDI
- FDA Product Code
- EGD FDA UDI
- GMDN Term
- Denture trial fabrication wax FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6890 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Denture trial fabrication wax
AxioModelling Wax 225g 12 sheets by Axiodent Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Denture trial fabrication wax.
- Hiflex Modelling Wax — PREVEST DENPRO LIMITED · Class I
- Hiflex Modelling Wax — PREVEST DENPRO LIMITED · Class I
- AxioModelling Wax 500g 24 sheets — Axiodent Inc. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Axiodent Inc.
Sources (1)
- FDA UDI f1d51928-fc06-47c0-8f6d-97a30d3ae017 32 fields · synced Jun 8, 2026