BracePaste Fluoride Sealant Kit 020-039668

GUDID 00190746062896

ADHESIVE BRACEPASTE FLUORIDE SEALANT KIT

AMERICAN ORTHODONTICS CORPORATION

Orthodontic bracket adhesive
Primary Device ID00190746062896
NIH Device Record Keyd2f5f287-d4b0-450d-bcfb-d305ccbd227b
Commercial Distribution StatusIn Commercial Distribution
Brand NameBracePaste Fluoride Sealant Kit
Version Model Number020-039668
Catalog Number020-039668
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 Usefalse
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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100190746062896 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-05
Device Publish Date2024-10-28

Devices Manufactured by AMERICAN ORTHODONTICS CORPORATION

00190746062896 - BracePaste Fluoride Sealant Kit2024-11-05ADHESIVE BRACEPASTE FLUORIDE SEALANT KIT
00190746062896 - BracePaste Fluoride Sealant Kit2024-11-05 ADHESIVE BRACEPASTE FLUORIDE SEALANT KIT
00190746060779 - Iconix2024-10-28 COSMETIC ICONIX UL BIC 022 T-7 A=0 R=0 HGW
00190746060793 - Iconix2024-10-28 COSMETIC ICONIX UR BIC 022 T-7 A=0 R=0 HGW
00190746060809 - Iconix2024-10-28 COSMETIC ICONIX UR BIC 022 T-7 A=0 R=0 W/HK MES HGW
00190746060816 - Iconix2024-10-28 COSMETIC ICONIX UL BIC 022 T-7 A=0 R=0 W/HK MES HGW
00190746060830 - Iconix2024-10-28 COSMETIC ICONIX LR 2ND BIC 022 T-17 A+2 R=0 HGW
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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