Identity
- Trade Name
- Hiflex Modelling Wax FDA UDI
- Generic Name
- Denture trial fabrication wax FDA UDI
- Model / Reference
- 12 sheets 225g FDA UDI
Identifiers
- Catalog Number
- 13002 FDA UDI
- Primary DI / UDI-DI
- D967130020 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
No
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
Yes
FDA UDI
Category: Denture trial fabrication wax
Hiflex Modelling Wax by Prevest Denpro Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Denture trial fabrication wax.
- AxioModelling Wax 225g 12 sheets — Axiodent Inc. · Class I
- AxioModelling Wax 500g 24 sheets — Axiodent Inc. · Class I
- Hiflex Modelling Wax — PREVEST DENPRO LIMITED · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Prevest Denpro Limited
Sources (1)
- FDA UDI 775d50b7-46e8-4949-b138-5d6322bf5fa7 33 fields · synced Jun 8, 2026