AccessGUDID - DEVICE: Light Super Bond-M-L/C Orthodontic Adhesive Single Syringe (D83600490)

GUDID

Device Identifier (DI) Information

Brand Name: Light Super Bond-M-L/C Orthodontic Adhesive Single Syringe
Version or Model: 0049
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0049
Company Name: DENT ZAR, INC.

Primary DI Number: D83600490
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 789664455 *Terms of Use

Device Description: Light Super Bond represents state-of- the-art technology: it offers the most desirable characteristics, in versatility, ease of handling and reliability. • Unlimited working time-cures on demand with a visible light-curing unit. • Bracket compatibility-designed to be used with ceramic, plastic or metal brackets. • Viscosity-consistency of the Light Super Bond-M paste eliminates bracket flotation. • High light sensitivity of the material allows for the use of Light Super Bond-M not only for bonding translucent (plastic or ceramic) brackets, but also for light impermeable metal ones. • Light Super Bond-M is a light cured material, which allows for relief from time pressure. • The dentist, therefore, has plenty of time for cleaning the excess adhesive around the bracket bases. • Simplicity of application procedure, and relief from time pressure, results in obtaining reproducible bond strength, and precise bracket placement. • The material has superior resistance to discoloration. It is economical to use and has virtually no waste and long shelf life, all of which contribute to the ease of working with this product.

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":	Yes
For Single-Use:	Yes
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 [?]
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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3dc8b2ad-6b74-470e-b4f3-5ecd4f6ae279
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 03, 2016