Diastema 855-250

GUDID 00190746074493

DIASTEMA CLOSER KIT OF 10 PATIENTS

AMERICAN ORTHODONTICS CORPORATION

Orthodontic spring Orthodontic spring Orthodontic spring Orthodontic spring Orthodontic spring Orthodontic spring Orthodontic spring Orthodontic spring Orthodontic spring Orthodontic spring Orthodontic spring Orthodontic spring Orthodontic spring Orthodontic spring
Primary Device ID00190746074493
NIH Device Record Key5c51c5a7-49ad-4904-98c7-c8e439b7b815
Commercial Distribution StatusIn Commercial Distribution
Brand NameDiastema
Version Model Number855-250
Catalog Number855-250
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100190746074493 [Primary]
GS100190746074493 [Primary]
GS100190746074493 [Primary]
GS100190746074493 [Primary]
GS100190746074493 [Primary]
GS100190746074493 [Primary]
GS100190746074493 [Primary]
GS100190746074493 [Primary]
GS100190746074493 [Primary]
GS100190746074493 [Primary]
GS100190746074493 [Primary]
GS100190746074493 [Primary]
GS100190746074493 [Primary]
GS100190746074493 [Primary]

FDA Product Code

EJFBRACKET, METAL, ORTHODONTIC
EJFBRACKET, METAL, ORTHODONTIC
EJFBRACKET, METAL, ORTHODONTIC
EJFBRACKET, METAL, ORTHODONTIC
EJFBRACKET, METAL, ORTHODONTIC
EJFBRACKET, METAL, ORTHODONTIC
EJFBRACKET, METAL, ORTHODONTIC
EJFBRACKET, METAL, ORTHODONTIC
EJFBRACKET, METAL, ORTHODONTIC
EJFBRACKET, METAL, ORTHODONTIC
EJFBRACKET, METAL, ORTHODONTIC
EJFBRACKET, METAL, ORTHODONTIC
EJFBRACKET, METAL, ORTHODONTIC
EJFBRACKET, METAL, 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

On-Brand Devices [Diastema]

00190746074516DIASTEMA DB TUBE
00190746074509DIASTEMA SPRING
00190746074493DIASTEMA CLOSER KIT OF 10 PATIENTS

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