Identity
- Trade Name
- Hader FDA UDI
- Generic Name
- Dental casting wax FDA UDI
- Device Name
- Hader Plastic-Wax Bar Kit. Kit Contains . 6 Hader Yellow Riders-Standard (00842092105337). 1 Hader Insertion Tool (00842092105504). 2 Hader Plastic-Wax Bars (00842092105405). 6 Hader Green Processing Spacers (00842092105375) FDA UDI
- Model / Reference
- 0101731 FDA UDI
- Description
- Hader Plastic-Wax Bar Kit. Kit Contains . 6 Hader Yellow Riders-Standard (00842092105337). 1 Hader Insertion Tool (00842092105504). 2 Hader Plastic-Wax Bars (00842092105405). 6 Hader Green Processing Spacers (00842092105375) FDA UDI
Identifiers
- Catalog Number
- 0101731 FDA UDI
- Primary DI / UDI-DI
- 00842092155417 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Dental casting wax FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 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
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental casting wax
Hader by PREAT Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental casting wax.
- 3M™ — 3M Deutschland GmbH · Class I
- ROGSON WAX, MDC Dental — MDC DENTAL · Class I
- ROGSON WAX, MDC Dental — MDC DENTAL · Class I
- ROGSON WAX, MDC Dental — MDC DENTAL · Class I
- ROGSON WAX, MDC Dental — MDC DENTAL · Class I
- SYNOCTA PROSTHETICS — Institut Straumann SA · Class II
- BONEFIT IMPLANT SYSTEM ACCESSORIES & INSTRUMENTS — Institut Straumann SA · Class II
- ROGSON WAX, MDC Dental — MDC DENTAL · 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
- PREAT Corporation
Sources (1)
- FDA UDI f1863895-4a2b-43e7-9c82-b2022cb6d49e 35 fields · synced May 30, 2026