Orthocem 4000055255

GUDID 07899633826582

Orthocem is a light-curing orthodontic single syringe cement that promotes the union between ceramics or metal brackets to the enamel surface. It has a fluorescent substance that allows tracing the product when applying ultraviolet light, facilitating product removal from teeth, after removing brackets.

Dentscare Ltda

Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive
Primary Device ID07899633826582
NIH Device Record Key133cb542-4ae5-4c09-8701-11cecfee2843
Commercial Distribution StatusIn Commercial Distribution
Brand NameOrthocem
Version Model Number4g
Catalog Number4000055255
Company DUNS898067533
Company NameDentscare Ltda
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107899633826582 [Primary]
GS107899633826582 [Primary]
GS107899633826582 [Primary]
GS107899633826582 [Primary]
GS107899633826582 [Primary]
GS107899633826582 [Primary]
GS107899633826582 [Primary]
GS107899633826582 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBFMaterial, Tooth Shade, Resin
EBFMaterial, Tooth Shade, Resin
EBFMaterial, Tooth Shade, Resin
EBFMaterial, Tooth Shade, Resin
EBFMaterial, Tooth Shade, Resin
EBFMaterial, Tooth Shade, Resin
EBFMaterial, Tooth Shade, Resin
EBFMaterial, Tooth Shade, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-09
Device Publish Date2020-10-30

Devices Manufactured by Dentscare Ltda

07899633826582 - Orthocem2020-11-09Orthocem is a light-curing orthodontic single syringe cement that promotes the union between ceramics or metal brackets to the enamel surface. It has a fluorescent substance that allows tracing the product when applying ultraviolet light, facilitating product removal from teeth, after removing brackets.
07899633826582 - Orthocem2020-11-09 Orthocem is a light-curing orthodontic single syringe cement that promotes the union between ceramics or metal brackets to the e
07899633815227 - Allcem Veneer APS2020-09-22 Allcem Veneer APS is a light-curing resin cement for adhesive cementation of no-prep or indirect veneers of up to 1.5mm of thick
07899633815234 - Allcem Veneer APS2020-09-22 Allcem Veneer APS is a light-curing resin cement for adhesive cementation of no-prep or indirect veneers of up to 1.5mm of thick
07899633815241 - Allcem Veneer APS2020-09-22 Allcem Veneer APS is a light-curing resin cement for adhesive cementation of no-prep or indirect veneers of up to 1.5mm of thick
07899633815258 - Allcem Veneer APS2020-09-22 Allcem Veneer APS is a light-curing resin cement for adhesive cementation of no-prep or indirect veneers of up to 1.5mm of thick
07899633815265 - Allcem Veneer APS2020-09-22 Allcem Veneer APS is a light-curing resin cement for adhesive cementation of no-prep or indirect veneers of up to 1.5mm of thick
07899633815272 - Allcem Veneer APS2020-09-22 Allcem Veneer APS is a light-curing resin cement for adhesive cementation of no-prep or indirect veneers of up to 1.5mm of thick
07899633816552 - Allcem Veneer APS2020-09-22 Allcem Veneer APS Mini Kit.

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