| Primary Device ID | E2351782S0 |
| NIH Device Record Key | 3ea99818-1961-4ddc-8ce6-421fc19742af |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BeautiBond |
| Version Model Number | 001 |
| Catalog Number | 1782S |
| Company DUNS | 054618202 |
| Company Name | SHOFU DENTAL CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | 760-566-3528 |
| ckaemmerlen@shofu.com | |
| Phone | 760-566-3528 |
| ckaemmerlen@shofu.com | |
| Phone | 760-566-3528 |
| ckaemmerlen@shofu.com | |
| Phone | 760-566-3528 |
| ckaemmerlen@shofu.com | |
| Phone | 760-566-3528 |
| ckaemmerlen@shofu.com | |
| Phone | 760-566-3528 |
| ckaemmerlen@shofu.com | |
| Phone | 760-566-3528 |
| ckaemmerlen@shofu.com | |
| Phone | 760-566-3528 |
| ckaemmerlen@shofu.com | |
| Phone | 760-566-3528 |
| ckaemmerlen@shofu.com | |
| Phone | 760-566-3528 |
| ckaemmerlen@shofu.com | |
| Phone | 760-566-3528 |
| ckaemmerlen@shofu.com | |
| Phone | 760-566-3528 |
| ckaemmerlen@shofu.com | |
| Phone | 760-566-3528 |
| ckaemmerlen@shofu.com | |
| Phone | 760-566-3528 |
| ckaemmerlen@shofu.com |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | E2351782S0 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-09-10 |
| Device Publish Date | 2018-08-09 |
| E2351782100 | 10 each Light-Cure Self-Etching One Component Dental Adhesive with 10 Microbrushes - Sample Pack |
| E2351782250 | 25 each Light-Cure Self-Etching One Component Dental Adhesive with 25 Microbrushes - Sample Pack |
| E2351782S0 | 2 each Light-Cure Self-Etching One Component Dental Adhesive with 2 Microbrushes - Sample Pack. |
| E23517820500 | 50 each Light-Cure Self-Etching One Component Dental Adhesive with 50 Microbrushes. Contains DI' |
| E23517820 | BEAUTIBOND (50 Unit Kit) |
| E23517810 | BEAUTIBOND BOTTLE (6ml) |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BEAUTIBOND 77575762 3667742 Live/Registered |
Shofu, Inc. 2008-09-22 |