Identity
- Trade Name
- equilibrium® FDA UDI
- Generic Name
- Orthodontic bracket, metal FDA UDI
- Device Name
- equilibrium® mini Bracket, - 22° Torque, 0° Angulation for tooth 35 FDA UDI
- Model / Reference
- 722-401-35 FDA UDI
- Description
- equilibrium® mini Bracket, - 22° Torque, 0° Angulation for tooth 35 FDA UDI
Identifiers
- Primary DI / UDI-DI
- J011722401350 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
- 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
Category: Orthodontic bracket, metal
Accurate and reliable orthodontic devices for precise tooth movement. The equilibrium mini Bracket, -22° Torque, 0° Angulation for tooth 35 is a single-use, metallic orthodontic device designed for the duration of treatment before disposal.
Similar devices
Also classified as Orthodontic bracket, metal.
- Mini-Mono® — Forestadent Bernhard Förster GmbH · Class I
- Intrigue — LANCER ORTHODONTICS, INC. · Class II
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- LEGEND — GC Orthodontics America Inc. · Class I
- MIRABAY — MIRABAY ORTHODONTICS CORPORATION · Class I
- RMO — RMO · Class I
- Mini-Mono® — Forestadent Bernhard Förster GmbH · Class I
- Votion — ORTHO TECHNOLOGY, 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
- Dentaurum
Sources (1)
- FDA UDI 17b97889-9b5d-4531-9c3a-09f872ed1735 35 fields · synced Jul 6, 2026