Identity
- Trade Name
- SureSmile® FDA UDI
- Generic Name
- Orthodontic archwire FDA UDI
- Device Name
- Arch wire 18x18 CUNITI-NITI FDA UDI
- Model / Reference
- ASSY-000580 FDA UDI
- Description
- Arch wire 18x18 CUNITI-NITI FDA UDI
Identifiers
- Catalog Number
- ASSY-000580 FDA UDI
- Primary DI / UDI-DI
- 00856379007252 FDA UDI
- FDA Product Code
- DZC FDA UDI
- GMDN Term
- Orthodontic archwire 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthodontic archwire
SureSmile® by Orametrix, 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
- Orametrix, Inc.
Sources (1)
- FDA UDI d2ab38a5-a12d-4abb-ae05-cf4cf3b0fe3b 35 fields · synced Jun 1, 2026