Phase II

Basic Information

• Brand Name: Phase II
• Primary DI: D798PJMCFF0
• Version / Model: PJMCFF
• Catalog Number: PJMCFF
• Company Name: RELIANCE ORTHODONTIC PRODUCTS INC
• Labeler DUNS: 113170088
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-10
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 5c837534-060e-4e32-bc92-b0e48fa96b21
• Distribution End Date: 2016-11-15

Device Description

Phase II is intended for use in direct and indirect bonding of orthodontic brackets and appliances. This is a chemical cure adhesive system. The highly-filled paste provides a strong mechanical bond with metal and ceramic bracket bases. This Kit contains 18g Adhesive Paste A with fluoride in a Jar, 18g Adhesive Paste B in a Jars, 7g Maximum Cure Filled Bonding Resin A with Fluoride & Maximum Cure Filled Bonding Resin B, 9g liquid Etchant , mixing pad, spatulas and disposable brushes This Kit contains Fluoride. This kit contains Maximum Cure Sealants in place of Bonding Resin.

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
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	872.3750	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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
35870	Dental composite resin	A non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be 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	D798PJMCFF0	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K894566	000
K895523	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at refrigerated (2-8 Degrees C)