Acid Etchant Gel Syringe Tip 020-028537

GUDID 00190746136870

ADHESIVE ACID ETCHANT GEL SYRINGE TIP 20/PK

AMERICAN ORTHODONTICS CORPORATION

Dental etching solution
Primary Device ID00190746136870
NIH Device Record Key3d99ab7d-a9fc-4f47-8ad2-47b904b60cd7
Commercial Distribution StatusIn Commercial Distribution
Brand NameAcid Etchant Gel Syringe Tip
Version Model Number020-028537
Catalog Number020-028537
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-558-7687
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
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
GS100190746136870 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBFMaterial, Tooth Shade, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-10-15
Device Publish Date2019-05-21

Devices Manufactured by AMERICAN ORTHODONTICS CORPORATION

00190746067280 - Mini Master Series Bracket2026-02-27 1 PAT SETUP MINI MS MBT 022 U/L 7X7 IFIT W/HK 3,4,5 STICKY
00190746070761 - Mini Master Series Bracket2026-02-27 1 PAT SETUP MINI MS ROTH 022 U/L 7X7 IFIT W/HK 3,4,5 STICKY
00190746070785 - Mini Master Series Bracket2026-02-27 1 PAT SETUP MINI MS ROTH 022 U/L 6X6 IFIT W/HK 3,4,5 STICKY
00190746070808 - Mini Master Series Bracket2026-02-27 1 PAT SETUP MINI MS ROTH 018 U/L 7X7 IFIT W/HK 3,4,5 STICKY
00190746070822 - Mini Master Series Bracket2026-02-27 1 PAT SETUP MINI MS ROTH 022 U/L 5X5 W/HK 3 STICKY 197 PAD
00190746070853 - Mini Master Series Bracket2026-02-27 1 PAT SETUP MINI MS ROTH 022 U/L 5X5 W/HK 3,4,5 STICKY 197 PAD
00190746070860 - Mini Master Series Bracket2026-02-27 1 PAT SETUP MINI MS MBT 022 U/L 5X5 W/HK 3 UL3 T=0 STICKY 197 PAD
00190746070891 - Mini Master Series Bracket2026-02-27 1 PAT SETUP MINI MS MBT 022 U/L 5X5 W/HK 3,4,5 UL3 T=0 STICKY 197 PAD

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.