Identity
- Trade Name
- Adult Split Bionator FDA UDI
- Generic Name
- Orthodontic palate expander/teeth aligner, self-removable FDA UDI
- Model / Reference
- 5000192 FDA UDI
Identifiers
- Primary DI / UDI-DI
- D82850001920 FDA UDI
- FDA Product Code
- DYJ FDA UDI
- GMDN Term
- Orthodontic palate expander/teeth aligner, self-removable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.5410 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthodontic palate expander/teeth aligner, self-removable
Adult Split Bionator by Five Star Orthodontic Laboratory & Supply, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Five Star Orthodontic Laboratory & Supply, Inc.
Sources (1)
- FDA UDI f7a40ef8-4159-48c4-9445-8d50ad76a71c 32 fields · synced May 31, 2026