AccessGUDID - DEVICE: Light Bond (D798BILBPF0)

GUDID

Device Identifier (DI) Information

Brand Name: Light Bond
Version or Model: BILBPF
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BILBPF
Company Name: RELIANCE ORTHODONTIC PRODUCTS INC

Primary DI Number: D798BILBPF0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 113170088 *Terms of Use

Device Description: Light Bond is intended for use as a light cure bracket and lingual retainer adhesive. Light Bond™ LIGHT CURE SEALANT AND BRACKET BONDING SYSTEM KIT WITH FLUORIDE PRODUCT FEATURES: SMOOTH, TACKY PASTE VISCOSITY: The viscosity of Light Bond™ Regular Paste is very tacky which helps prevent bracket flotation. NO MIXING - UNLIMITED WORKING TIME: Light Bond™ is a photo initiated adhesive that offers the operator unlimited working time to position brackets and clean flash. BONDS TO METAL, CERAMIC & COMPOSITE SURFACES: Light Bond™ will bond to any enamel, porcelain, composite or metal surface, when properly conditioned. This is the 2 syringe kit configuration

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 [?]
K895522	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: Light Bond can be handled and stored at ambient temperatures

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 687cc5ca-192f-4a17-b20c-5dcafd97d2f8
Public Version Date: September 10, 2018
Public Version Number: 1
DI Record Publish Date: August 10, 2018