Identity
- Trade Name
- SureSmile® FDA UDI
- Generic Name
- Orthodontic progressive aligner FDA UDI
- Device Name
- SureSmile Aligner (10 hours/day) FDA UDI
- Model / Reference
- 1000 FDA UDI
- Description
- SureSmile Aligner (10 hours/day) FDA UDI
Identifiers
- Catalog Number
- ASSY-500016 FDA UDI
- Primary DI / UDI-DI
- 00856379007276 FDA UDI
- FDA Product Code
- NXC FDA UDI
- GMDN Term
- Orthodontic progressive aligner FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.5470 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthodontic progressive aligner
SureSmile® by Orametrix, Inc. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Orametrix, Inc.
Sources (1)
- FDA UDI 2427c574-9a55-4140-9702-c557c69fa832 35 fields · synced May 29, 2026