AccessGUDID - DEVICE: GoTo (D798GTP0)

GUDID

Device Identifier (DI) Information

Brand Name: GoTo
Version or Model: GTP
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: GTP
Company Name: RELIANCE ORTHODONTIC PRODUCTS INC

Primary DI Number: D798GTP0
Issuing Agency: HIBCC
Commercial Distribution End Date: May 21, 2026
Device Count: 1
Labeler D-U-N-S® Number*: 113170088 *Terms of Use

Device Description: GoTo™ is intended for use as a light cure bracket adhesive. This is a 4 gm push syringe

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 [?]
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: d93a5d44-9404-4fd9-9bd5-eec7bcbad539
Public Version Date: May 29, 2026
Public Version Number: 3
DI Record Publish Date: November 01, 2016