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

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00190746062964 - Mini Master Series2025-01-22 DB BKT MINI MS UR CEN 022 T+22 A+5 R=0 GP
00190746062971 - Mini Master Series2025-01-22 DB BKT MINI MS UL CEN 022 T+22 A+5 R=0 GP
00190746062988 - Mini Master Series2025-01-22 DB BKT MINI MS UR LAT 022 T+14 A+8 R=0 GP
00190746063008 - Mini Master Series2025-01-22 DB BKT MINI MS UL LAT 022 T+14 A+8 R=0 GP
00190746063015 - Mini Master Series2025-01-22 DB BKT MINI MS UR CUSP 022 T=0 A+7 R=0 GP
00190746063022 - Mini Master Series2025-01-22 DB BKT MINI MS UL CUSP 022 T=0 A+7 R=0 GP
00190746063046 - Mini Master Series2025-01-22 DB BKT MINI MS LR CUSP 022 T=0 A+5 R=0 BEV GP

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