DEVICE: Ribbond Bondable Reinfocement Ribbon (D758U0)

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If so, send a picture of the label to GUDIDSupport@fda.hhs.gov.

Device Identifier (DI) Information

Ribbond Bondable Reinfocement Ribbon
ULTRA
In Commercial Distribution

RIBBOND, INC
D758U0
HIBCC

1
796596989 *Terms of Use
Dental fiber reinforcement Ultra thin
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
44786 Dental reinforcing fibre
A 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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
EBI Resin, Denture, Relining, Repairing, Rebasing
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Length: 68 Centimeter
Length: 22 Centimeter
Width: 4 Millimeter
Width: 3 Millimeter
Width: 2 Millimeter
Width: 1 Millimeter
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Device Record Status

d93082f4-3ceb-49ae-a3a8-1c504de39770
March 09, 2026
5
September 23, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
D758UK35781 3 D758U0 In Commercial Distribution
D758UK35931 1 D758U0 In Commercial Distribution
D758UK35941 1 D758U0 In Commercial Distribution
D758UK35951 1 D758U0 In Commercial Distribution
D758UK36001 1 D758U0 In Commercial Distribution
D758UK35881 1 D758U0 In Commercial Distribution
D758UK35921 1 D758U0 In Commercial Distribution
D758UK35891 1 D758U0 In Commercial Distribution
D758UK36051 1 D758U0 In Commercial Distribution
D758UK35821 3 D758U0 In Commercial Distribution
D758UK35871 3 D758U0 In Commercial Distribution
D758UK36011 1 D758U0 In Commercial Distribution
D758UK36061 3 D758U0 In Commercial Distribution
D758UK36071 3 D758U0 In Commercial Distribution
D758UK36021 1 D758U0 In Commercial Distribution
D758UK36031 1 D758U0 In Commercial Distribution
D758UK35831 3 D758U0 In Commercial Distribution
D758UK35911 1 D758U0 In Commercial Distribution
D758UK35901 1 D758U0 In Commercial Distribution
D758UK35961 1 D758U0 In Commercial Distribution
D758UK36041 3 D758U0 In Commercial Distribution
D758UK35791 1 D758U0 In Commercial Distribution
D758UK35801 1 D758U0 In Commercial Distribution
D758UK35811 1 D758U0 In Commercial Distribution
D758UK35991 3 D758U0 In Commercial Distribution
D758UK35841 3 D758U0 In Commercial Distribution
D758UK35861 3 D758U0 In Commercial Distribution
D758UK35851 3 D758U0 In Commercial Distribution
D758UK36191 3 D758U0 In Commercial Distribution
D758UK36201 3 D758U0 In Commercial Distribution
D758UK36181 3 D758U0 In Commercial Distribution
D758UK36211 3 D758U0 In Commercial Distribution
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
2063408870
ribbond@ribbond.com
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