| Primary Device ID | D758RR0 |
| NIH Device Record Key | f7a0fefe-7ab0-41e5-90d6-79eddcc399ca |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ribbond Wetting Resin |
| Version Model Number | 1 |
| Catalog Number | RESIN |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 2063408870 |
| ribbond@ribbond.com | |
| Phone | 2063408870 |
| ribbond@ribbond.com | |
| Phone | 2063408870 |
| ribbond@ribbond.com | |
| Phone | 2063408870 |
| ribbond@ribbond.com | |
| Phone | 2063408870 |
| ribbond@ribbond.com | |
| Phone | 2063408870 |
| ribbond@ribbond.com | |
| Phone | 2063408870 |
| ribbond@ribbond.com | |
| Phone | 2063408870 |
| ribbond@ribbond.com | |
| Phone | 2063408870 |
| ribbond@ribbond.com | |
| Phone | 2063408870 |
| ribbond@ribbond.com | |
| Phone | 2063408870 |
| ribbond@ribbond.com | |
| Phone | 2063408870 |
| ribbond@ribbond.com | |
| Phone | 2063408870 |
| ribbond@ribbond.com | |
| Phone | 2063408870 |
| ribbond@ribbond.com |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D758RR0 [Primary] |
| KLE | Agent, Tooth Bonding, Resin |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-10-28 |
| Device Publish Date | 2018-04-23 |
| D758SC00110 - RIBBOND SCISSORS | 2025-07-07 RIBBOND SCISSORS to cut dental fiber reinforcement |
| D758O0 - Ribbond Bondable Reinfocement Ribbon | 2025-06-27 Dental fiber reinforcement. |
| D758T0 - Ribbond Bondable Reinfocement Ribbon | 2025-06-27 Dental fiber reinforcement THM (Thinner Higher Modulus) |
| D758U0 - Ribbond Bondable Reinfocement Ribbon | 2025-06-27 Dental fiber reinforcement Ultra thin |
| D758X0 - Ribbond Bondable Reinfocement Ribbond | 2025-06-27 Dental fiber reinforcement. |
| D758II0 - Ribbond Scissors | 2023-07-28 Scissors to cut Ribbond dental reinforcement |
| D758RR0 - Ribbond Wetting Resin | 2019-10-28 light curing, unfilled dental adhesive used as an interface between Ribbond fibers and composite. |
| D758RR0 - Ribbond Wetting Resin | 2019-10-28 light curing, unfilled dental adhesive used as an interface between Ribbond fibers and composite. |