Identity
- Trade Name
- SPEED Convertible Buccal Tube with Head Gear FDA UDI
- Generic Name
- Orthodontic bracket, metal FDA UDI
- Model / Reference
- 75402950200082 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 75402950200082 FDA UDI
- FDA Product Code
- EJF FDA UDI
- GMDN Term
- Orthodontic bracket, metal FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.5410 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
SPEED Convertible Buccal Tube with Head Gear by Hespeler Orthodontics Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Hespeler Orthodontics Limited
Sources (1)
- FDA UDI 3e80ea27-c6ca-4d74-8c3c-db7409f691b8 33 fields · synced May 30, 2026