AccessGUDID - DEVICE: Gel Etchant (D7981EGSS0)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: D7981EGSS0
Issuing Agency: HIBCC
Commercial Distribution End Date: April 07, 2026
Device Count: 1
Labeler D-U-N-S® Number*: 113170088 *Terms of Use

Device Description: Gel Etchant is intended for use in the etching of enamel surface prior to bonding. This is a 6.5gm push syringe of gel etchant.

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: Storage at room temperature (15-30 Degrees C)

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: baee2a28-02b0-4b3a-a370-18130a76d6a7
Public Version Date: May 25, 2026
Public Version Number: 7
DI Record Publish Date: September 03, 2016