Identity
- Trade Name
- College Kit FDA UDI
- Generic Name
- Orthodontic wire FDA UDI
- Device Name
- The University College Kit includes 1 syringe Ultra Band Lok Blue, 1 syringe Light Bond bracket adhesive, 1 x 2ml bottle Assure Plus Universal Bonding Resin, 1 x Flowtain syringe for lingual retention, Ortho FlexTech and Bond A Braid Lingual retainer wires and Technical Bonding Cards FDA UDI
- Model / Reference
- UNIVHAND14 FDA UDI
- Description
- The University College Kit includes 1 syringe Ultra Band Lok Blue, 1 syringe Light Bond bracket adhesive, 1 x 2ml bottle Assure Plus Universal Bonding Resin, 1 x Flowtain syringe for lingual retention, Ortho FlexTech and Bond A Braid Lingual retainer wires and Technical Bonding Cards FDA UDI
Identifiers
- Catalog Number
- UNIVHAND14 FDA UDI
- Primary DI / UDI-DI
- D798UNIVHAND140 FDA UDI
- FDA Product Code
- EBF FDA UDIDZC FDA UDIDYH FDA UDIKLE FDA UDI
- GMDN Term
- Orthodontic wire FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3690 FDA UDI872.5410 FDA UDI872.3750 FDA UDI872.3200 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
College Kit by Reliance Orthodontic Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 II | Pending data |
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Manufacturer
- Manufacturer
- Reliance Orthodontic Products, Inc.
Sources (1)
- FDA UDI f8036455-834a-4425-96f7-4f39bdffa879 37 fields · synced May 31, 2026