Identity
- Trade Name
- Preat Implant Prosthetics FDA UDI
- Generic Name
- Denture clasp mould FDA UDI
- Device Name
- Hader Bar Kit Kit contains: 2 Hader Plastic Bar Patterns (Standard) 6 Hader Yellow Riders-Standard 6 Hader Green Processing Spacers 1 Hader Insertion Tool FDA UDI
- Model / Reference
- 0101701 FDA UDI
- Description
- Hader Bar Kit Kit contains: 2 Hader Plastic Bar Patterns (Standard) 6 Hader Yellow Riders-Standard 6 Hader Green Processing Spacers 1 Hader Insertion Tool FDA UDI
Identifiers
- Catalog Number
- 0101701 FDA UDI
- Primary DI / UDI-DI
- 00842092176368 FDA UDI
- FDA Product Code
- EGG FDA UDI
- GMDN Term
- Denture clasp mould FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3165 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: Denture clasp mould
Preat Implant Prosthetics by PREAT Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Denture clasp mould.
- Hader Bar — PREAT Corporation · Class I
- Preci-Bar — PREAT Corporation · Class I
- Preci-Bar — PREAT Corporation · Class I
- Preci-Bar — PREAT Corporation · Class I
- Precision Attachments — PREAT Corporation · Class I
- Hader — PREAT Corporation · Class I
- Preat — PREAT Corporation · Class I
- Preci-Bar — PREAT Corporation · 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
- PREAT Corporation
Sources (1)
- FDA UDI 695ae9f6-c300-4e64-b655-1a707c506a4f 34 fields · synced May 30, 2026