Ribbond Bondable Reinfocement Ribbon

GUDID D758O0

Dental fiber reinforcement.

RIBBOND, INC

Dental reinforcing fibre

Primary Device ID	D758O0
NIH Device Record Key	4d49bfdd-8a07-48c8-b389-3198a88c018d
Commercial Distribution Status	In Commercial Distribution
Brand Name	Ribbond Bondable Reinfocement Ribbon
Version Model Number	Original
Company DUNS	796596989
Company Name	RIBBOND, INC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Customer Support Contacts

Phone	2063408870
Email	ribbond@ribbond.com
Phone	2063408870
Email	ribbond@ribbond.com
Phone	2063408870
Email	ribbond@ribbond.com
Phone	2063408870
Email	ribbond@ribbond.com
Phone	2063408870
Email	ribbond@ribbond.com
Phone	2063408870
Email	ribbond@ribbond.com
Phone	2063408870
Email	ribbond@ribbond.com
Phone	2063408870
Email	ribbond@ribbond.com
Phone	2063408870
Email	ribbond@ribbond.com
Phone	2063408870
Email	ribbond@ribbond.com
Phone	2063408870
Email	ribbond@ribbond.com
Phone	2063408870
Email	ribbond@ribbond.com
Phone	2063408870
Email	ribbond@ribbond.com
Phone	2063408870
Email	ribbond@ribbond.com
Phone	2063408870
Email	ribbond@ribbond.com
Phone	2063408870
Email	ribbond@ribbond.com
Phone	2063408870
Email	ribbond@ribbond.com
Phone	2063408870
Email	ribbond@ribbond.com
Phone	2063408870
Email	ribbond@ribbond.com
Phone	2063408870
Email	ribbond@ribbond.com
Phone	2063408870
Email	ribbond@ribbond.com
Phone	2063408870
Email	ribbond@ribbond.com
Phone	2063408870
Email	ribbond@ribbond.com
Phone	2063408870
Email	ribbond@ribbond.com
Phone	2063408870
Email	ribbond@ribbond.com
Phone	2063408870
Email	ribbond@ribbond.com

Device Dimensions

Width	9 Millimeter
Width	4 Millimeter
Width	3 Millimeter
Width	2 Millimeter
Length	22 Centimeter
Length	68 Centimeter
Width	9 Millimeter
Width	4 Millimeter
Width	3 Millimeter
Width	2 Millimeter
Length	22 Centimeter
Length	68 Centimeter
Width	9 Millimeter
Width	4 Millimeter
Width	3 Millimeter
Width	2 Millimeter
Length	22 Centimeter
Length	68 Centimeter
Width	9 Millimeter
Width	4 Millimeter
Width	3 Millimeter
Width	2 Millimeter
Length	22 Centimeter
Length	68 Centimeter
Width	9 Millimeter
Width	4 Millimeter
Width	3 Millimeter
Width	2 Millimeter
Length	22 Centimeter
Length	68 Centimeter
Width	9 Millimeter
Width	4 Millimeter
Width	3 Millimeter
Width	2 Millimeter
Length	22 Centimeter
Length	68 Centimeter
Width	9 Millimeter
Width	4 Millimeter
Width	3 Millimeter
Width	2 Millimeter
Length	22 Centimeter
Length	68 Centimeter
Width	9 Millimeter
Width	4 Millimeter
Width	3 Millimeter
Width	2 Millimeter
Length	22 Centimeter
Length	68 Centimeter
Width	9 Millimeter
Width	4 Millimeter
Width	3 Millimeter
Width	2 Millimeter
Length	22 Centimeter
Length	68 Centimeter
Width	9 Millimeter
Width	4 Millimeter
Width	3 Millimeter
Width	2 Millimeter
Length	22 Centimeter
Length	68 Centimeter
Width	9 Millimeter
Width	4 Millimeter
Width	3 Millimeter
Width	2 Millimeter
Length	22 Centimeter
Length	68 Centimeter
Width	9 Millimeter
Width	4 Millimeter
Width	3 Millimeter
Width	2 Millimeter
Length	22 Centimeter
Length	68 Centimeter
Width	9 Millimeter
Width	4 Millimeter
Width	3 Millimeter
Width	2 Millimeter
Length	22 Centimeter
Length	68 Centimeter
Width	9 Millimeter
Width	4 Millimeter
Width	3 Millimeter
Width	2 Millimeter
Length	22 Centimeter
Length	68 Centimeter
Width	9 Millimeter
Width	4 Millimeter
Width	3 Millimeter
Width	2 Millimeter
Length	22 Centimeter
Length	68 Centimeter
Width	9 Millimeter
Width	4 Millimeter
Width	3 Millimeter
Width	2 Millimeter
Length	22 Centimeter
Length	68 Centimeter
Width	9 Millimeter
Width	4 Millimeter
Width	3 Millimeter
Width	2 Millimeter
Length	22 Centimeter
Length	68 Centimeter
Width	9 Millimeter
Width	4 Millimeter
Width	3 Millimeter
Width	2 Millimeter
Length	22 Centimeter
Length	68 Centimeter
Width	9 Millimeter
Width	4 Millimeter
Width	3 Millimeter
Width	2 Millimeter
Length	22 Centimeter
Length	68 Centimeter
Width	9 Millimeter
Width	4 Millimeter
Width	3 Millimeter
Width	2 Millimeter
Length	22 Centimeter
Length	68 Centimeter
Width	9 Millimeter
Width	4 Millimeter
Width	3 Millimeter
Width	2 Millimeter
Length	22 Centimeter
Length	68 Centimeter
Width	9 Millimeter
Width	4 Millimeter
Width	3 Millimeter
Width	2 Millimeter
Length	22 Centimeter
Length	68 Centimeter
Width	9 Millimeter
Width	4 Millimeter
Width	3 Millimeter
Width	2 Millimeter
Length	22 Centimeter
Length	68 Centimeter
Width	9 Millimeter
Width	4 Millimeter
Width	3 Millimeter
Width	2 Millimeter
Length	22 Centimeter
Length	68 Centimeter
Width	9 Millimeter
Width	4 Millimeter
Width	3 Millimeter
Width	2 Millimeter
Length	22 Centimeter
Length	68 Centimeter
Width	9 Millimeter
Width	4 Millimeter
Width	3 Millimeter
Width	2 Millimeter
Length	22 Centimeter
Length	68 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D758O0 [Primary]
HIBCC	D758OK00231 [Package] Package: [3 Units] In Commercial Distribution
HIBCC	D758OK00301 [Package] Package: [1 Units] In Commercial Distribution
HIBCC	D758OK00311 [Package] Package: [1 Units] In Commercial Distribution
HIBCC	D758OK00321 [Package] Package: [1 Units] In Commercial Distribution
HIBCC	D758OK00341 [Package] Package: [3 Units] In Commercial Distribution
HIBCC	D758OK00491 [Package] Package: [1 Units] In Commercial Distribution
HIBCC	D758OK00911 [Package] Package: [3 Units] In Commercial Distribution
HIBCC	D758OK01361 [Package] Package: [3 Units] In Commercial Distribution
HIBCC	D758OK34661 [Package] Package: [1 Units] In Commercial Distribution
HIBCC	D758OK34681 [Package] Package: [1 Units] In Commercial Distribution
HIBCC	D758OK34691 [Package] Package: [1 Units] In Commercial Distribution
HIBCC	D758OK34811 [Package] Package: [1 Units] In Commercial Distribution
HIBCC	D758OK34921 [Package] Package: [3 Units] In Commercial Distribution
HIBCC	D758OK34931 [Package] Package: [3 Units] In Commercial Distribution
HIBCC	D758OK34941 [Package] Package: [3 Units] In Commercial Distribution
HIBCC	D758OK35591 [Package] Package: [1 Units] In Commercial Distribution
HIBCC	D758OK35601 [Package] Package: [1 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K913040

FDA Product Code

EBI	Resin, Denture, Relining, Repairing, Rebasing

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2025-06-27
Device Publish Date	2016-09-23

On-Brand Devices [Ribbond Bondable Reinfocement Ribbon]

D758U0	Dental fiber reinforcement Ultra thin
D758T0	Dental fiber reinforcement THM (Thinner Higher Modulus)
D758O0	Dental fiber reinforcement.