Identity
- Trade Name
- AURADONICS FDA UDI
- Generic Name
- Orthodontic inter-bracket elastic chain FDA UDI
- Device Name
- CHAIN CONT - LILAC, 7.5 FT each, see www.auradonics.com FDA UDI
- Model / Reference
- 700-532 7.5 FDA UDI
- Description
- CHAIN CONT - LILAC, 7.5 FT each, see www.auradonics.com FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810033834240 FDA UDI
- FDA Product Code
- ECI FDA UDI
- GMDN Term
- Orthodontic inter-bracket elastic chain 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 inter-bracket elastic chain
Auradonics by Auradonics Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic inter-bracket elastic chain.
- Orthodontic Bonding Trays — ORTHO ARCH COMPANY INC · Class I
- E-Links Modules — TP ORTHODONTICS, INC. · Class I
- Power Sticks — ORTHO TECHNOLOGY, INC. · Class I
- Power Sticks — ORTHO TECHNOLOGY, INC. · Class I
- 3M™ AlastiK™ — 3M UNITEK CORPORATION · Class I
- 3M™ AlastiK™ — 3M UNITEK CORPORATION · Class I
- 3M™ AlastiK™ — 3M UNITEK CORPORATION · Class I
- MIRABAY — MIRABAY ORTHODONTICS CORPORATION · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Auradonics Inc.
Sources (1)
- FDA UDI 16b267dc-e4bb-4c72-8e48-2ded6c581a52 35 fields · synced May 30, 2026