AccessGUDID - DEVICE: Phase II (D798PJMCFF0)

GUDID

Device Identifier (DI) Information

Brand Name: Phase II
Version or Model: PJMCFF
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: PJMCFF
Company Name: RELIANCE ORTHODONTIC PRODUCTS INC

Primary DI Number: D798PJMCFF0
Issuing Agency: HIBCC
Commercial Distribution End Date: November 15, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 113170088 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DYH	Adhesive, Bracket And Tooth Conditioner, Resin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K894566	000
K895523	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store at refrigerated (2-8 Degrees C)

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5c837534-060e-4e32-bc92-b0e48fa96b21
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 10, 2016