Identity
- Trade Name
- Indirect Bonding Tray FDA UDI
- Generic Name
- Orthodontic appliance/positioning tray kit FDA UDI
- Model / Reference
- 700D FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817645020207 FDA UDI
- FDA Product Code
- KMY FDA UDI
- GMDN Term
- Orthodontic appliance/positioning tray kit 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 appliance/positioning tray kit
Indirect Bonding Tray by Six Month Smiles — 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
- Six Month Smiles
Sources (1)
- FDA UDI b2b30a20-1b2c-43b8-a829-811151dc4b28 32 fields · synced May 31, 2026