AccessGUDID - DEVICE: Phase II (D798DCSF0)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: D798DCSF0
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. This kit contains 3 X 6g Phase II Pastes A with Fluoride & B in screw syringes, 2 X 3cc Light Bond Sealant Resins and 1x 9g liquid etchant with and mixing accessories. Kit 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:	No
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?
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
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 ◦ C) Protect from light.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0a8f2e44-546e-4cd1-b048-ed72a4b4eae5
Public Version Date: October 29, 2018
Public Version Number: 4
DI Record Publish Date: August 10, 2016