AccessGUDID - DEVICE: Blue Gel Etchant (D7981BGS0)

GUDID

Device Identifier (DI) Information

Brand Name: Blue Gel Etchant
Version or Model: 1BGS
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1BGS
Company Name: RELIANCE ORTHODONTIC PRODUCTS INC

Primary DI Number: D7981BGS0
Issuing Agency: HIBCC
Commercial Distribution End Date: November 01, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 113170088 *Terms of Use

Device Description: Blue Gel Etchant is intended for use in etching the tooth surface. Product has high visibility blue color. Product contains BAC (Benzalchromium chloride). 5 gm 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?
36153	Dental tooth-etching solution	An acid solution, in liquid or gel form, intended to be applied to tooth surfaces to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant; it is also referred to as dental etchant. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KLE	Agent, Tooth Bonding, 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
Special Storage Condition, Specify: Store at room temperature (15-30 Degrees C)

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 40f2a1e1-71b1-40af-8cee-a733b6d323f2
Public Version Date: October 09, 2025
Public Version Number: 5
DI Record Publish Date: September 03, 2016