AccessGUDID - DEVICE: Light Bond (D798LBPTF1)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: D798LBPTF1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 11
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™ will bond to any enamel, porcelain, composite or metal surface, when properly conditioned. This is a 5 g Light Bond adhesive paste with fluoride in dispensing tips. Qty 11 tips per package.

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 [?]
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: Store at room temperature (15-30 Degrees C) Avoid excessive heat. Allow product to reach room temperature prior to use

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9ed2313c-8bf4-4433-8841-acee53b95b7a
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 03, 2016