Identity
- Trade Name
- Preat FDA UDI
- Generic Name
- Magnetic dental precision attachment FDA UDI
- Device Name
- K-Line Magnet Positioning Cuff FDA UDI
- Model / Reference
- 1400515 FDA UDI
- Description
- K-Line Magnet Positioning Cuff FDA UDI
Identifiers
- Catalog Number
- 1400515 FDA UDI
- Primary DI / UDI-DI
- 00842092126356 FDA UDI
- FDA Product Code
- EGG FDA UDI
- GMDN Term
- Magnetic dental precision attachment FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3165 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Preat by PREAT Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 42ecf395-daac-48f4-8d87-99e673522f12 36 fields · synced May 31, 2026