AccessGUDID - DEVICE: Phase II Dual Cure (D7981DCSAF0)

GUDID

Device Identifier (DI) Information

Brand Name: Phase II Dual Cure
Version or Model: 1DCSAF
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1DCSAF
Company Name: RELIANCE ORTHODONTIC PRODUCTS INC

Primary DI Number: D7981DCSAF0
Issuing Agency: HIBCC
Commercial Distribution End Date:
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 Dual Cure. 1 X 6g Dual Cure Phase II Adhesive Paste A with Fluoride in screw syringe

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).

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1b60b664-306b-48ca-8850-a85dcfa944c8
Public Version Date: October 29, 2018
Public Version Number: 4
DI Record Publish Date: September 04, 2016