AccessGUDID - DEVICE: Quick Set Paste B (D867CLQSPB0)

GUDID

Device Identifier (DI) Information

Brand Name: Quick Set Paste B
Version or Model: CLQSPB
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CLQSPB
Company Name: Xemax Surgical Products Inc

Primary DI Number: D867CLQSPB0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 804495695 *Terms of Use

Device Description: Quick Set Paste is intended for use as an orthodontic bonding adhesive for brackets and appliances.

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
DYH	ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K875144	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 room temperature (15-30 Degrees C / Not to exceed 86 Degrees F)

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ff980e6d-513d-412a-a8ae-6b5aad0b5348
Public Version Date: July 06, 2018
Public Version Number: 2
DI Record Publish Date: May 31, 2018