| Primary Device ID | E23502030 |
| NIH Device Record Key | 4c07f2ed-89b4-4cd2-8457-8f496ed650ff |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DURA-WHITE |
| Version Model Number | 0203 |
| Catalog Number | 0203 |
| 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 | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)827-5262 |
| customer-service@shofu.com | |
| Phone | +1(800)827-5262 |
| customer-service@shofu.com | |
| Phone | +1(800)827-5262 |
| customer-service@shofu.com | |
| Phone | +1(800)827-5262 |
| customer-service@shofu.com | |
| Phone | +1(800)827-5262 |
| customer-service@shofu.com | |
| Phone | +1(800)827-5262 |
| customer-service@shofu.com | |
| Phone | +1(800)827-5262 |
| customer-service@shofu.com | |
| Phone | +1(800)827-5262 |
| customer-service@shofu.com | |
| Phone | +1(800)827-5262 |
| customer-service@shofu.com | |
| Phone | +1(800)827-5262 |
| customer-service@shofu.com | |
| Phone | +1(800)827-5262 |
| customer-service@shofu.com | |
| Phone | +1(800)827-5262 |
| customer-service@shofu.com | |
| Phone | +1(800)827-5262 |
| customer-service@shofu.com | |
| Phone | +1(800)827-5262 |
| customer-service@shofu.com | |
| Phone | +1(800)827-5262 |
| customer-service@shofu.com | |
| Phone | +1(800)827-5262 |
| customer-service@shofu.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | E23502030 [Primary] |
| EHL | POINT, ABRASIVE |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[E23502030]
Moist Heat or Steam Sterilization
[E23502030]
Moist Heat or Steam Sterilization
[E23502030]
Moist Heat or Steam Sterilization
[E23502030]
Moist Heat or Steam Sterilization
[E23502030]
Moist Heat or Steam Sterilization
[E23502030]
Moist Heat or Steam Sterilization
[E23502030]
Moist Heat or Steam Sterilization
[E23502030]
Moist Heat or Steam Sterilization
[E23502030]
Moist Heat or Steam Sterilization
[E23502030]
Moist Heat or Steam Sterilization
[E23502030]
Moist Heat or Steam Sterilization
[E23502030]
Moist Heat or Steam Sterilization
[E23502030]
Moist Heat or Steam Sterilization
[E23502030]
Moist Heat or Steam Sterilization
[E23502030]
Moist Heat or Steam Sterilization
[E23502030]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-02-11 |
| Device Publish Date | 2021-02-03 |
| E23502500 | FG DURA-WHITE WH1 |
| E23502490 | FG DURA-WHITE TC1 |
| E23502480 | FG DURA-WHITE RD2 |
| E23502470 | FG DURA-WHITE RD1 |
| E23502460 | FG DURA-WHITE KN1 |
| E23502450 | FG DURA-WHITE IC2 |
| E23502440 | FG DURA-WHITE FL2 |
| E23502430 | FG DURA-WHITE CY2 |
| E23502410 | FG DURA-WHITE CN1 |
| E23502320 | CA DURA-WHITE WH4 |
| E23502300 | CA DURA-WHITE TC1 |
| E23502290 | CA DURA-WHITE RE1 |
| E23502280 | CA DURA-WHITE RD2 |
| E23502270 | CA DURA-WHITE RD1 |
| E23502250 | CA DURA-WHITE IC4 |
| E23502240 | CA DURA-WHITE FL3 |
| E23502230 | CA DURA-WHITE FL2 |
| E23502220 | CA DURA-WHITE FL1 |
| E23502210 | CA DURA-WHITE CN1 |
| E23502120 | HP DURA-WHITE WH4 |
| E23502110 | HP DURA-WHITE TC4 |
| E23502100 | HP DURA-WHITE TC1 |
| E23502090 | HP DURA-WHITE RE1 |
| E23502080 | HP DURA-WHITE RD2 |
| E23502070 | HP DURA-WHITE RD1 |
| E23502060 | HP DURA-WHITE KN3 |
| E23502050 | HP DURA-WHITE IC4 |
| E23502040 | HP DURA-WHITE FL3 |
| E23502030 | HP DURA-WHITE FL2 |
| E23502020 | HP DURA-WHITE FL1 |
| E23502010 | HP DURA-WHITE CN1 |
| E23502400 | DURA-WHITE FL1 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() DURA-WHITE 85392398 not registered Dead/Abandoned |
Jarden Zinc Products, LLC 2011-08-08 |
![]() DURA-WHITE 73342407 1210766 Dead/Cancelled |
Athlone Industries, Inc. 1981-12-18 |