Identity
- Trade Name
- equilibrium® FDA UDI
- Generic Name
- Orthodontic bracket, metal FDA UDI
- Device Name
- equilibrium® 2 Band bracket with hook, - 17° Torque, + 2° Angulation for tooth 45 FDA UDI
- Model / Reference
- 790-288-02 FDA UDI
- Description
- equilibrium® 2 Band bracket with hook, - 17° Torque, + 2° Angulation for tooth 45 FDA UDI
Identifiers
- Primary DI / UDI-DI
- J011790288020 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
A comprehensive medical device for orthodontic treatment, offering a single-patient solution with a metal bracket bonded to an orthodontic band or directly to a tooth. Equilibrium is a 2-3 band bracket designed for the duration of the treatment, before being discarded.
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
- Dentaurum
Sources (1)
- FDA UDI d2ae3472-1113-4dfd-af18-54e0255b0a1f 36 fields · synced Jul 2, 2026