FDA.reportPublic FDA data

Ribbond Wetting Resin

Primary DI
D758RR0
Brand
Ribbond Wetting Resin
Company
RIBBOND, INC
Model
1
Catalog number
RESIN
Device description
light curing, unfilled dental adhesive used as an interface between Ribbond fibers and composite.
Published
2018-04-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KLEAgent, Tooth Bonding, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLEAgent, Tooth Bonding, ResinDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D758RR0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dentine bonding agent/setA material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material. It includes a resin-based bonding agent and may also include a primer and/or etching solution (as a single formulation or as part of a set); composite resin is not included. It may also be used as an enamel bonding material. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature41 Degrees Fahrenheit80 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
2063408870ribbond@ribbond.com

Regulatory Flags#

DUNS number
796596989
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D758O0Ribbond Bondable Reinfocement RibbonOriginal2016-09-23
D758T0Ribbond Bondable Reinfocement RibbonTHM2016-09-23
D758U0Ribbond Bondable Reinfocement RibbonULTRA2016-09-23
D758SC00110RIBBOND SCISSORS1SCISSORS2025-06-27
D758X0Ribbond Bondable Reinfocement RibbondTriaxial2016-09-23
D758II0Ribbond Scissors12023-07-20
D758SCISSORS1Ribbond Scissors1SCISSORS2019-02-08
D758TX5070Ribbond Placement Instrument1ENIN2018-10-31
D758OK0Ribbond Bondable Reinfocement Ribbon KitOriginal2016-09-23
D758TK0Ribbond Bondable Reinfocement Ribbon KitTHM2016-09-23
D758UK0Ribbond Bondable Reinfocement Ribbon KitULTRA2016-09-23
D758XK0Ribbond Bondable Reinfocement Ribbond KitTriaxial2016-09-23
D046CC0Ribbond Securing Composite1TIPS2017-10-31

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Primary DI, Brand, Company table
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