Eagle No Drift 001-943

GUDID 00190746007651

EAGLE NO DRIFT ADHESIVE CARPULE 20/PKG

AMERICAN ORTHODONTICS CORPORATION

Orthodontic bracket adhesive
Primary Device ID00190746007651
NIH Device Record Key8200ce2b-3166-4ad8-b112-ad91b35c60d5
Commercial Distribution Discontinuation2018-07-17
Commercial Distribution StatusNot in Commercial Distribution
Brand NameEagle No Drift
Version Model Number001-943
Catalog Number001-943
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 Datetrue
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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light

Device Identifiers

Device Issuing AgencyDevice ID
GS100190746007651 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DYHADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-18
Device Publish Date2016-11-09

On-Brand Devices [Eagle No Drift]

00190746134098EAGLE NO DRIFT ADHESIVE CARPULE 20/PKG
00190746134081EAGLE NO DRIFT ADHESIVE CARPULE KIT
00190746007743EAGLE NO DRIFT MODIFIED SEALANT 6 GMS
00190746007682EAGLE NO DRIFT ADHESIVE CARPULE KIT W/ FLUORSURE SEALANT
00190746007668EAGLE NO DRIFT ADHESIVE CARPULE-TRANSPARENT 20/PKG
00190746007651EAGLE NO DRIFT ADHESIVE CARPULE 20/PKG
00190746000027EAGLE NO DRIFT ADHESIVE CARPULE KIT

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