Ribbond Bondable Reinfocement Ribbon

Primary DI
D758T0
Brand
Ribbond Bondable Reinfocement Ribbon
Company
RIBBOND, INC
Model
THM
Device description
Dental fiber reinforcement THM (Thinner Higher Modulus)
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
D758TK35031PackageHIBCC1In Commercial Distribution
D758TK35041PackageHIBCC1In Commercial Distribution
D758TK35051PackageHIBCC1In Commercial Distribution
D758TK35061PackageHIBCC3In Commercial Distribution
D758TK35071PackageHIBCC3In Commercial Distribution
D758TK35081PackageHIBCC1In Commercial Distribution
D758TK35091PackageHIBCC1In Commercial Distribution
D758TK35101PackageHIBCC1In Commercial Distribution
D758TK35111PackageHIBCC3In Commercial Distribution
D758TK35121PackageHIBCC3In Commercial Distribution
D758TK35131PackageHIBCC1In Commercial Distribution
D758TK35141PackageHIBCC1In Commercial Distribution
D758TK35151PackageHIBCC1In Commercial Distribution
D758TK35161PackageHIBCC1In Commercial Distribution
D758TK35171PackageHIBCC1In Commercial Distribution
D758TK35211PackageHIBCC1In Commercial Distribution
D758TK35361PackageHIBCC3In Commercial Distribution
D758TK35371PackageHIBCC3In Commercial Distribution
D758TK35381PackageHIBCC3In Commercial Distribution
D758TK35391PackageHIBCC3In Commercial Distribution
D758TK35571PackageHIBCC3In Commercial Distribution
D758TK35581PackageHIBCC1In Commercial Distribution
D758TK35611PackageHIBCC1In Commercial Distribution
D758TK35621PackageHIBCC1In Commercial Distribution
D758TK35631PackageHIBCC1In Commercial Distribution
D758TK35701PackageHIBCC3In Commercial Distribution
D758TK36091PackageHIBCC1In Commercial Distribution
D758TK36101PackageHIBCC3In Commercial Distribution
D758TK36111PackageHIBCC3In Commercial Distribution
D758TK36121PackageHIBCC3In Commercial Distribution
D758TK36141PackageHIBCC3In Commercial Distribution
D758TK36151PackageHIBCC3In Commercial Distribution
D758TK36161PackageHIBCC3In Commercial Distribution
D758TK36171PackageHIBCC3In Commercial Distribution
D758T0PrimaryHIBCC0

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

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
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D758O0Ribbond Bondable Reinfocement RibbonOriginal2016-09-23
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07615208482775ProBase Hot / ProBase ColdIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-04-30
08056640078369major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-04-27
08056640078857major.repairMAJOR PRODOTTI DENTARI SPAEBI2026-04-27
07701126631194Opti-Cryl Pour Acrylic Original X 22 lbPRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S AEBI2026-04-23
EPRC66100851dima Print Denture Base 2pro3dure medical GmbHEBI2025-07-31
08435288443584IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443591IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443614IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443645IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443669IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443690IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443607IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443621IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443638IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443652IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443676IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443683IDODENTINEUNION DENTAL SAEBI2024-11-27
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