AccessGUDID - DEVICE: Phase II (D798PESF0)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: D798PESF0
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: Phase II is intended for use in direct and indirect bonding of orthodontic brackets and appliances. The highly-filled paste provides a strong mechanical bond with metal and ceramic bracket bases. Kit contains: 18g Catalyst Paste A with fluoride, 18g Base Paste B, 7g Bonding Resin A with fluoride &B, 9g Liquid Etchant, mixing pad, spatulas, disposable brushes. This kit with 3 X 6g Screw Syringes paste A & B, 20g Sealant Resin A & B, 23g 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?
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 [?]
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: Storage at room temperature (15-30 Degrees C)

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ba51d7bf-234b-485e-a7c1-7c677b985a15
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 06, 2016