Identity
- Trade Name
- DeLuke Bonded Frameless Expander FDA UDI
- Generic Name
- Orthodontic palate expander screw, bonded FDA UDI
- Device Name
- DeLuke Bonded Frameless Expander FDA UDI
- Model / Reference
- 3000-0045 FDA UDI
- Description
- DeLuke Bonded Frameless Expander FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889989038699 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
DeLuke Bonded Frameless 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 |
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Manufacturer
- Manufacturer
- Allesee Aoa-Pro
Sources (1)
- FDA UDI 2e011b10-b9a5-4a65-a60f-6d96d672372f 34 fields · synced May 29, 2026