AccessGUDID - DEVICE: Phase II (D798DCJF0)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: D798DCJF0
Issuing Agency: HIBCC
Commercial Distribution End Date: December 21, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 113170088 *Terms of Use

Device Description: PhaseII® Dual Cure is intended for use as an orthodontic adhesive for direct and indirect bonding. Phase II® DUAL CURE combines the best of both chemical and light cure polymerization. The chemical cure working time is 4 minutes to allow several brackets to be set and positioned from one mix. An initial set can be immediately achieved by light curing from any angle for 10 seconds. This will prevent the loss of bond strength due to saliva contamination. This unique dual cure process allows complete polymerization under metal brackets where the light does not reach. When an immediate final set is desired, simply light cure a metal or ceramic bracket for 30 seconds. This kit contains paste in 18g jars A & B and 2 X 3cc Sealant Resin and 1 9g etchant. Contains Fluoride

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?
35697	Dental material application tool, single-use	A hand-held manual dental instrument intended to be used for the application of a dental restorative material (e.g., amalgam, resin) to a patient’s tooth/teeth; the restorative material is not included. It includes a handle with an application tip/brush which holds the material on its surface/bristles; it is not a syringe- or pistol-like device. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBF	Material, Tooth Shade, Resin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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 room temperature (15-30 Degrees C) Protect from Light

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4dae4b93-acb0-4d4f-a3be-d2bdf94888bd
Public Version Date: November 08, 2018
Public Version Number: 5
DI Record Publish Date: August 08, 2016