MR Lock LC 001-975

GUDID 00190746007880

MR LOCK BAND CEMENT KIT

AMERICAN ORTHODONTICS CORPORATION

Orthodontic bracket adhesive
Primary Device ID00190746007880
NIH Device Record Key94449dd4-7eec-47d4-aa9e-262448494556
Commercial Distribution StatusIn Commercial Distribution
Brand NameMR Lock LC
Version Model Number001-975
Catalog Number001-975
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 Kittrue
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
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

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
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100190746007880 [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 Number3
Public Version Date2018-07-06
Device Publish Date2016-11-09

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00190746060847 - Iconix2024-10-28 COSMETIC ICONIX LL 2ND BIC 022 T-17 A+2 R=0 HGW
00190746060854 - Iconix2024-10-28 COSMETIC ICONIX LR CUSP 022 T=0 A+3 R=0 W/HK DIST
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