Bondable Space Maintainer 855-320

GUDID 00190746074981

SPACE MAINTAINER KIT OF 16

AMERICAN ORTHODONTICS CORPORATION

Orthodontic space maintainer
Primary Device ID00190746074981
NIH Device Record Keyb40bc03e-aeea-4fd5-8f04-75a989e04c4d
Commercial Distribution StatusIn Commercial Distribution
Brand NameBondable Space Maintainer
Version Model Number855-320
Catalog Number855-320
Company DUNS044668515
Company NameAMERICAN ORTHODONTICS CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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

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
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
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
GS100190746074981 [Primary]

FDA Product Code

DYTMAINTAINER, SPACE PREFORMED, ORTHODONTIC

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-14
Device Publish Date2020-09-04

Devices Manufactured by AMERICAN ORTHODONTICS CORPORATION

00190746070662 - NT32025-08-26 WIRE NITI FORM I LOWER 014X025 100/PK
00190746070686 - NT32025-08-26 WIRE NITI FORM I UPPER 014X025 100/PK
00190746070709 - NT32025-08-26 WIRE NITI FORM III LOWER 014X025 100/PK
00190746070723 - NT32025-08-26 WIRE NITI FORM III UPPER 014X025 100/PK
00190746064968 - NiTi Spring2025-08-21 NITI SPRING CLOSED COIL CONTINUOUS FORCE LIGHT 100g 9MM WITH EYELET 10/PK
00190746064975 - NiTi Spring2025-08-21 NITI SPRING CLOSED COIL CONTINUOUS FORCE LIGHT 100g 12MM WITH EYELET 10/PK
00190746064982 - NiTi Spring2025-08-21 NITI SPRING CLOSED COIL CONTINUOUS FORCE MED 150g 9MM WITH EYELET 10/PK
00190746064999 - NiTi Spring2025-08-21 NITI SPRING CLOSED COIL CONTINUOUS FORCE MED 150g 12MM WITH EYELET 10/PK
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.