EU College Kit

Basic Information

• Brand Name: EU College Kit
• Primary DI: D798EUUNIVHAND0
• Version / Model: EUUNIVHAND
• Catalog Number: EUUNIVHAND
• Company Name: RELIANCE ORTHODONTIC PRODUCTS INC
• Labeler DUNS: 113170088
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-04-04
• Public Version: 2
• Public Version Date: 2024-02-16
• Public Version Status: Update
• Public Device Record Key: 95a229d7-241d-4a2a-a94e-82c94aeb5ce0

Device Description

The University College Kit includes 1 syringe Ultra Band Lok Blue NonFluoride, 1 syringe GoTo bracket adhesive, 1 x 2ml bottle Assure Plus Universal Bonding Resin, 1 x Flowtain syringe for lingual retention, Ortho FlexTech and Retainium Lingual retainer wires and Technical Bonding Cards

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KLE	Agent, Tooth Bonding, Resin	Dental	872.3200	2
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	872.3750	2
DZC	Wire, Orthodontic	Dental	872.5410	1
EBF	Material, Tooth Shade, Resin	Dental	872.3690	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16204	Orthodontic wire	A thread or slender rod of metal (e.g., stainless steel, precious metal) incorporated into an orthodontic appliance, typically as part of an orthodontic appliance system. It is available in various dimensions and grades, and is used to exert pressure on teeth in order to alter their position. This is a single-patient device that is used for the duration of the treatment (single-use) before being discarded.	No	Active
31750	Orthodontic bracket adhesive	A bonding compound, e.g., polymethylmethacrylate (PMMA), used specifically to cement an orthodontic bracket to the surface of a tooth. After application, this device cannot be reused.	No	Active
34782	Dentine bonding agent/set	A material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material; it may also be used as an enamel bonding material. It includes a resin-based bonding agent and may also include a primer, etching solution or curing activator, within the same formulation, or as part of a set. It is not a primer, etching solution and/or activator sold in the absence of a bonding agent; composite resin is not included. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D798EUUNIVHAND0	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at room temperature (15-30 Degrees C) Avoid excessive heat.