Ribbond Bondable Reinfocement Ribbond

GUDID D758X0

Dental fiber reinforcement.

RIBBOND, INC

Dental reinforcing fibre
Primary Device IDD758X0
NIH Device Record Key05bc04d1-cff5-4e21-a324-f01fd6b353e7
Commercial Distribution StatusIn Commercial Distribution
Brand NameRibbond Bondable Reinfocement Ribbond
Version Model NumberTriaxial
Company DUNS796596989
Company NameRIBBOND, INC
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone2063408870
Emailribbond@ribbond.com
Phone2063408870
Emailribbond@ribbond.com
Phone2063408870
Emailribbond@ribbond.com
Phone2063408870
Emailribbond@ribbond.com
Phone2063408870
Emailribbond@ribbond.com
Phone2063408870
Emailribbond@ribbond.com
Phone2063408870
Emailribbond@ribbond.com
Phone2063408870
Emailribbond@ribbond.com
Phone2063408870
Emailribbond@ribbond.com
Phone2063408870
Emailribbond@ribbond.com
Phone2063408870
Emailribbond@ribbond.com
Phone2063408870
Emailribbond@ribbond.com
Phone2063408870
Emailribbond@ribbond.com
Phone2063408870
Emailribbond@ribbond.com

Device Dimensions

Length15 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length22 Centimeter
Length15 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length22 Centimeter
Length15 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length22 Centimeter
Length15 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length22 Centimeter
Length15 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length22 Centimeter
Length15 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length22 Centimeter
Length15 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length22 Centimeter
Length15 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length22 Centimeter
Length15 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length22 Centimeter
Length15 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length22 Centimeter
Length15 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length22 Centimeter
Length15 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length22 Centimeter
Length15 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length22 Centimeter
Length15 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length22 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD758X0 [Primary]
HIBCCD758XK35431 [Package]
Package: [3 Units]
In Commercial Distribution
HIBCCD758XK35461 [Package]
Package: [3 Units]
In Commercial Distribution
HIBCCD758XK35661 [Package]
Package: [3 Units]
In Commercial Distribution
HIBCCD758XK35671 [Package]
Package: [3 Units]
In Commercial Distribution
HIBCCD758XK35751 [Package]
Package: [1 Units]
In Commercial Distribution
HIBCCD758XK35761 [Package]
Package: [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBIResin, Denture, Relining, Repairing, Rebasing

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2025-06-27
Device Publish Date2016-09-23

Devices Manufactured by RIBBOND, INC

D758SC00110 - RIBBOND SCISSORS2025-07-07 RIBBOND SCISSORS to cut dental fiber reinforcement
D758O0 - Ribbond Bondable Reinfocement Ribbon2025-06-27 Dental fiber reinforcement.
D758T0 - Ribbond Bondable Reinfocement Ribbon2025-06-27 Dental fiber reinforcement THM (Thinner Higher Modulus)
D758U0 - Ribbond Bondable Reinfocement Ribbon2025-06-27 Dental fiber reinforcement Ultra thin
D758X0 - Ribbond Bondable Reinfocement Ribbond2025-06-27Dental fiber reinforcement.
D758X0 - Ribbond Bondable Reinfocement Ribbond2025-06-27 Dental fiber reinforcement.
D758II0 - Ribbond Scissors2023-07-28 Scissors to cut Ribbond dental reinforcement
D758RR0 - Ribbond Wetting Resin2019-10-28 light curing, unfilled dental adhesive used as an interface between Ribbond fibers and composite.

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