Identity
- Trade Name
- 3M™ Unitek™ FDA UDI
- Generic Name
- Orthodontic inter-arch elastic band FDA UDI
- Device Name
- 3M™ Unitek™ Elastics, 404-226, Medium-Light 3.5 oz, 3/16 in, Green (Dwight), 100/Pk, 30 Pk/Ct FDA UDI
- Model / Reference
- 404-226 FDA UDI
- Description
- 3M™ Unitek™ Elastics, 404-226, Medium-Light 3.5 oz, 3/16 in, Green (Dwight), 100/Pk, 30 Pk/Ct FDA UDI
Identifiers
- Catalog Number
- 404-226 FDA UDI
- Primary DI / UDI-DI
- 60652221303433 FDA UDI
- FDA Product Code
- ECI FDA UDI
- GMDN Term
- Orthodontic inter-arch elastic band 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
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthodontic inter-arch elastic band
A comprehensive medical device for orthodontic treatment, specifically designed to exert a continuous light force to adjust bite and jaw position. Made of elastomeric material, this single-patient device is intended to be replaced regularly during treatment.
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Also classified as Orthodontic inter-arch elastic band.
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- KIT ADVANCED METAL BRACKETS ROTH 0.022 10 SETS + ARCHES + ELASTIC — ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA · Class I
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- Young Specialties — Young Innovations, 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
- 3m Unitek Corporation
Sources (1)
- FDA UDI 200fba46-a1f8-4008-9138-566c245018a4 35 fields · synced Jul 24, 2026