Acid Etchant 020-033808

GUDID 00190746071003

ADHESIVE ACID ETCHANT GEL SYRINGE TIP 20/PK

AMERICAN ORTHODONTICS CORPORATION

Dental tooth-etching solution
Primary Device ID00190746071003
NIH Device Record Key424a26d5-7991-4406-9177-2adf0ce8a5b7
Commercial Distribution StatusIn Commercial Distribution
Brand NameAcid Etchant
Version Model Number020-033808
Catalog Number020-033808
Company DUNS044668515
Company NameAMERICAN ORTHODONTICS CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100190746071003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KLEAGENT, TOOTH BONDING, RESIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-05
Device Publish Date2026-01-28

On-Brand Devices [Acid Etchant]

00190746136863ADHESIVE ACID ETCHANT LIQUID GREEN 37% 18ml BOTTLE
00190746134753ADHESIVE ACID ETCHANT GEL GREEN 37% 10ml SYRINGE AND TIPS
00190746059247ADHESIVE ACID ETCHANT LIQUID GREEN 37% 18g BOTTLE
00190746059230ADHESIVE ACID ETCHANT GEL GREEN 37% 10ml SYRINGE AND TIPS
00190746071003ADHESIVE ACID ETCHANT GEL SYRINGE TIP 20/PK

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