Identity
- Trade Name
- ORJ FDA UDI
- Generic Name
- Orthodontic spring FDA UDI
- Device Name
- Orthodontic Niti Coil Springs FDA UDI
- Model / Reference
- W612-1212 FDA UDI
- Description
- Orthodontic Niti Coil Springs FDA UDI
Identifiers
- Primary DI / UDI-DI
- D115W61212121 FDA UDI
- FDA Product Code
- ECO FDA UDI
- GMDN Term
- Orthodontic spring 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
No
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
No
FDA UDI
Category: Orthodontic spring
Orj by Fortune Worldwide LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic spring.
- Original Side-Winder Uprighting Spring — TP ORTHODONTICS, INC. · Class I
- TruFlex — ORTHO TECHNOLOGY, INC. · Class I
- RMO — RMO · Class I
- Stainless Steel Closed Coil Spring — ORTHO ARCH COMPANY INC · Class I
- Orthodontic Spring — DENTOS Inc. · Class I
- OSE — ORTHODONTIC SUPPLY & EQUIPMENT CO., INC. · Class I
- Begg Spring-Pin — TP ORTHODONTICS, INC. · Class I
- Ortho Organizers — Ortho Organizers, Inc. · Class I
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
- Fortune Worldwide LLC
Sources (1)
- FDA UDI 6c094feb-ba3c-4eaa-a5af-c4eb302b7979 33 fields · synced May 30, 2026