DEVICE: Ribbond Bondable Reinfocement Ribbon (D758T0)
Notice: Any discrepancies with this record compared to the label?
If so, send a picture of the label to
GUDIDSupport@fda.hhs.gov.
Device Identifier (DI) Information
Ribbond Bondable Reinfocement Ribbon
THM
In Commercial Distribution
RIBBOND, INC
THM
In Commercial Distribution
RIBBOND, INC
Dental fiber reinforcement THM (Thinner Higher Modulus)
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 |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| EBI | Resin, Denture, Relining, Repairing, Rebasing |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Width: 7 Millimeter |
| Width: 1 Millimeter |
| Width: 2 Millimeter |
| Width: 3 Millimeter |
| Width: 4 Millimeter |
| Length: 22 Centimeter |
| Length: 68 Centimeter |
Device Record Status
8bb79ed9-d43c-423e-8951-2979ef8f0988
March 09, 2026
5
September 23, 2016
March 09, 2026
5
September 23, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| D758TK35071 | 3 | D758T0 | In Commercial Distribution | ||
| D758TK35081 | 1 | D758T0 | In Commercial Distribution | ||
| D758TK35141 | 1 | D758T0 | In Commercial Distribution | ||
| D758TK35621 | 1 | D758T0 | In Commercial Distribution | ||
| D758TK35051 | 1 | D758T0 | In Commercial Distribution | ||
| D758TK35391 | 3 | D758T0 | In Commercial Distribution | ||
| D758TK35161 | 1 | D758T0 | In Commercial Distribution | ||
| D758TK35381 | 3 | D758T0 | In Commercial Distribution | ||
| D758TK35581 | 1 | D758T0 | In Commercial Distribution | ||
| D758TK35131 | 1 | D758T0 | In Commercial Distribution | ||
| D758TK35091 | 1 | D758T0 | In Commercial Distribution | ||
| D758TK36091 | 1 | D758T0 | In Commercial Distribution | ||
| D758TK35061 | 3 | D758T0 | In Commercial Distribution | ||
| D758TK35571 | 3 | D758T0 | In Commercial Distribution | ||
| D758TK35101 | 1 | D758T0 | In Commercial Distribution | ||
| D758TK35211 | 1 | D758T0 | In Commercial Distribution | ||
| D758TK35171 | 1 | D758T0 | In Commercial Distribution | ||
| D758TK36101 | 3 | D758T0 | In Commercial Distribution | ||
| D758TK35371 | 3 | D758T0 | In Commercial Distribution | ||
| D758TK35151 | 1 | D758T0 | In Commercial Distribution | ||
| D758TK36111 | 3 | D758T0 | In Commercial Distribution | ||
| D758TK35631 | 1 | D758T0 | In Commercial Distribution | ||
| D758TK36121 | 3 | D758T0 | In Commercial Distribution | ||
| D758TK35121 | 3 | D758T0 | In Commercial Distribution | ||
| D758TK35361 | 3 | D758T0 | In Commercial Distribution | ||
| D758TK35611 | 1 | D758T0 | In Commercial Distribution | ||
| D758TK35031 | 1 | D758T0 | In Commercial Distribution | ||
| D758TK35041 | 1 | D758T0 | In Commercial Distribution | ||
| D758TK35111 | 3 | D758T0 | In Commercial Distribution | ||
| D758TK35701 | 3 | D758T0 | In Commercial Distribution | ||
| D758TK36171 | 3 | D758T0 | In Commercial Distribution | ||
| D758TK36141 | 3 | D758T0 | In Commercial Distribution | ||
| D758TK36151 | 3 | D758T0 | In Commercial Distribution | ||
| D758TK36161 | 3 | D758T0 | In Commercial Distribution |
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
2063408870
ribbond@ribbond.com
ribbond@ribbond.com