Orthocryl®

GUDID J011161607000

Orthocryl® Disco glitter, blue

DENTAURUM GmbH & Co.KG

Orthodontic appliance system, bonded
Primary Device IDJ011161607000
NIH Device Record Key74b0b7ab-e62a-49f4-a14b-82ca24908a0a
Commercial Distribution StatusIn Commercial Distribution
Brand NameOrthocryl®
Version Model Number161-607-00
Company DUNS315427286
Company NameDENTAURUM GmbH & Co.KG
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 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)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *No special storage conditions required
Special Storage Condition, SpecifyBetween 0 and 0 *No special storage conditions required
Special Storage Condition, SpecifyBetween 0 and 0 *No special storage conditions required
Special Storage Condition, SpecifyBetween 0 and 0 *No special storage conditions required
Special Storage Condition, SpecifyBetween 0 and 0 *No special storage conditions required
Special Storage Condition, SpecifyBetween 0 and 0 *No special storage conditions required
Special Storage Condition, SpecifyBetween 0 and 0 *No special storage conditions required
Special Storage Condition, SpecifyBetween 0 and 0 *No special storage conditions required
Special Storage Condition, SpecifyBetween 0 and 0 *No special storage conditions required
Special Storage Condition, SpecifyBetween 0 and 0 *No special storage conditions required
Special Storage Condition, SpecifyBetween 0 and 0 *No special storage conditions required
Special Storage Condition, SpecifyBetween 0 and 0 *No special storage conditions required
Special Storage Condition, SpecifyBetween 0 and 0 *No special storage conditions required
Special Storage Condition, SpecifyBetween 0 and 0 *No special storage conditions required
Special Storage Condition, SpecifyBetween 0 and 0 *No special storage conditions required
Special Storage Condition, SpecifyBetween 0 and 0 *No special storage conditions required
Special Storage Condition, SpecifyBetween 0 and 0 *No special storage conditions required
Special Storage Condition, SpecifyBetween 0 and 0 *No special storage conditions required
Special Storage Condition, SpecifyBetween 0 and 0 *No special storage conditions required
Special Storage Condition, SpecifyBetween 0 and 0 *No special storage conditions required
Special Storage Condition, SpecifyBetween 0 and 0 *No special storage conditions required
Special Storage Condition, SpecifyBetween 0 and 0 *No special storage conditions required
Special Storage Condition, SpecifyBetween 0 and 0 *No special storage conditions required
Special Storage Condition, SpecifyBetween 0 and 0 *No special storage conditions required
Special Storage Condition, SpecifyBetween 0 and 0 *No special storage conditions required

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCJ011161607000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KMYPOSITIONER, TOOTH, PREFORMED

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2021-02-05
Device Publish Date2016-09-15

On-Brand Devices [Orthocryl®]

J011161139000Orthocryl® liquid, neon blue
J011161912000Orthocryl® assortment, clear / orthodontic acrylics / For further information please visit our
J011161622000Orthocryl® Color concentrate, blue/ orthodontic acrylics
J011161620000Orthocryl® Color concentrate, red/ orthodontic acrylics
J011161611000Orthocryl® Disco glitter, mother of pearl
J011161609000Orthocryl® Disco glitter, gold
J011161608000Orthocryl® Disco glitter, silver
J011161607000Orthocryl® Disco glitter, blue
J011161606000Orthocryl® Disco glitter, red
J011161605000Orthocryl® Disco glitter, iris
J011161350000Orthocryl® liquid, transparent pink/ orthodontic acrylics
J011161300000Orthocryl® liquid, transparent pink/ orthodontic acrylics
J011161229000Orthocryl® liquid "Somno blue"
J011161227000Orthocryl® liquid "Somno pink"
J011161150000Orthocryl® liquid, clear/ orthodontic acrylics
J011161138000Orthocryl® liquid, neon green / orthodontic acrylics
J011161137000Orthocryl® liquid, neon pink / orthodontic acrylics
J011161136000Orthocryl® liquid, neon orange / orthodontic acrylics
J011161135000Orthocryl® liquid, neon yellow / orthodontic acrylics
J011161134000Orthocryl® liquid, violet / orthodontic acrylics
J011161133000Orthocryl® liquid, emerald green / orthodontic acrylics
J011161132000Orthocryl® liquid, hot pink / orthodontic acrylics
J011161131000Orthocryl® liquid, turquois/ orthodontic acrylics
J011161130000Orthocryl® liquid, yellow/ orthodontic acrylics
J011161129000Orthocryl® liquid, blue/ orthodontic acrylics
J011161128000Orthocryl® liquid, green/ orthodontic acrylics
J011161127000Orthocryl® liquid, red/ orthodontic acrylics
J011161100000Orthocryl® liquid, clear/ orthodontic acrylics
J011160700000Orthocryl® assortment, neon colors / orthodontic acrylics / For further information please visi
J011160600000Orthocryl®assortm."Multicolored palette" / orthodontic acrylics / For further information pleas
J011160502000Orthocryl® Small pack, clear/ orthodontic acrylics
J011160501000Orthocryl® Small pack, transparent pink/ orthodontic acrylics
J011160410000Bite paste for Orthocryl® LC, transparent
J011160406000Orthocryl® LC, green/ orthodontic acrylics
J011160405000Orthocryl® LC, yellow/ orthodontic acrylics
J011160404000Orthocryl® LC, blue/ orthodontic acrylics
J011160403000Orthocryl® LC, red/ orthodontic acrylics
J011160402000Orthocryl® LC, transparent pink/ orthodontic acrylics
J011160401000Orthocryl® LC, clear/ orthodontic acrylics
J011160400200Orthocryl® LC Start-Set, clear / orthodontic acrylics / For further information please visit ou
J011160400000Orthocryl® LC Start-Set german / orthodontic acrylics / For further information please visit ou
J011160301000Orthocryl® EQ powder, clear/ orthodontic acrylics
J011160300000Orthocryl® EQ powder, clear/ orthodontic acrylics
J011160212000Orthocryl® powder, clear/ orthodontic acrylics
J011160112000Orthocryl® powder, clear/ orthodontic acrylics
J011160014000Orthocryl® white powder/ orthodontic acrylics
J011160013000Orthocryl® black powder/ orthodontic acrylics
J011160012000Orthocryl® white powder/ orthodontic acrylics
J011160011000Orthocryl® black powder/ orthodontic acrylics

Trademark Results [Orthocryl]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ORTHOCRYL
ORTHOCRYL
77593145 3825857 Live/Registered
DENTAURUM GMBH & CO. KG
2008-10-15
ORTHOCRYL
ORTHOCRYL
72407471 1027656 Dead/Expired
STRATFORD-COOKSON COMPANY
1971-11-11

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.