Identity
- Trade Name
- AURADONICS FDA UDI
- Generic Name
- Orthodontic archwire/bracket ligature FDA UDI
- Device Name
- FIGURE 8s MEDIUM - BABY PINK, 200 devices per package, see www.auradonics.com FDA UDI
- Model / Reference
- 300-731 FDA UDI
- Description
- FIGURE 8s MEDIUM - BABY PINK, 200 devices per package, see www.auradonics.com FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810033832048 FDA UDI
- FDA Product Code
- ECI FDA UDI
- GMDN Term
- Orthodontic archwire/bracket ligature 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthodontic archwire/bracket ligature
Auradonics is a patented device designed to securely tether an orthodontic archwire to an orthodontic bracket or hold the archwire in place, providing a convenient and reliable solution for orthodontic treatment. This single-use, implantable device is available for replacement during treatment and is in compliance with FDA regulations.
Similar devices
Also classified as Orthodontic archwire/bracket ligature.
- SELECT-TIES — G&H Wire Company, Inc. · Class I
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- 3M™ AlastiK™ — 3M UNITEK CORPORATION · Class I
- Mini Stix Ligature Ties — TP ORTHODONTICS, INC. · Class I
- MINI-TIES — Ortho Organizers, Inc. · Class I
- Plak Smacker — Young Innovations, Inc. · Class I
- Plak Smacker — Young Innovations, Inc. · Class I
- VERSA-TIES — G&H Wire Company, 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
- Auradonics Inc.
Sources (1)
- FDA UDI a92bed89-bfb3-40c9-9632-944a38caa0f9 35 fields · synced Jun 27, 2026