FDA.reportPublic FDA data

Ribbond Bondable Reinfocement Ribbon Kit

Primary DI
D758TK0
Brand
Ribbond Bondable Reinfocement Ribbon Kit
Company
RIBBOND, INC
Model
THM
Device description
Dental fiber reinforcement THM (Thinner Higher Modulus) Kit
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBIResin, Denture, Relining, Repairing, Rebasing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBIResin, Denture, Relining, Repairing, RebasingDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K913040000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K913040000RIBBOND(TM)Ribbond, Inc.1991-10-07EBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D758TK1PackageHIBCC3In Commercial Distribution
D758TK0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental reinforcing fibreA device used in general restorative dentistry and orthodontic treatment typically as reinforcement of dental polymer-based materials, used for the construction of dental prostheses, i.e., splints, posts, crowns, and bridges. This device is typically made of polyethylene (PE) fibres supplied in strands, braid, or ribbon in a variety of sizes. It may also be used for the stabilization of avulsed teeth maintaining diastema closures or split-tooth syndrome. The ultrahigh molecular weight PE fibres increase the strength of composite materials, and provide improved safety by assisting in the retention of pieces in the event that a dental prosthesis is broken. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length22Centimeter
Length68Centimeter
Width1Millimeter
Width2Millimeter
Width3Millimeter
Width4Millimeter
Width7Millimeter

Contacts#

Phone, Email table
PhoneEmail
2063408870ribbond@ribbond.com

Regulatory Flags#

DUNS number
796596989
Device count
1
Lot or batch
true
Manufacturing 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
D758RR0Ribbond Wetting Resin1RESIN2018-04-23
D758II0Ribbond Scissors12023-07-20
D758SCISSORS1Ribbond Scissors1SCISSORS2019-02-08
D758TX5070Ribbond Placement Instrument1ENIN2018-10-31
D758OK0Ribbond Bondable Reinfocement Ribbon KitOriginal2016-09-23
D758UK0Ribbond Bondable Reinfocement Ribbon KitULTRA2016-09-23
D758XK0Ribbond Bondable Reinfocement Ribbond KitTriaxial2016-09-23
D046CC0Ribbond Securing Composite1TIPS2017-10-31

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