Identity
- Trade Name
- Arnold Expander FDA UDI
- Generic Name
- Orthodontic palate expander screw, bonded FDA UDI
- Device Name
- Arnold Expander FDA UDI
- Model / Reference
- 3000-0052 FDA UDI
- Description
- Arnold Expander FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889989088069 FDA UDI
- FDA Product Code
- KMY FDA UDI
- GMDN Term
- Orthodontic palate expander screw, bonded FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.5525 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthodontic palate expander screw, bonded
Arnold Expander by Allesee Aoa-Pro — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic palate expander screw, bonded.
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
- Allesee Aoa-Pro
Sources (1)
- FDA UDI 786dbd8b-2b9d-4816-af14-591d4b4d3493 34 fields · synced May 30, 2026