| Primary Device ID | EFORG76301011 |
| NIH Device Record Key | b424c578-b5f6-4253-a8d2-ff5ddd13b0b2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | N.A. |
| Version Model Number | G763-0101 |
| Company DUNS | 316074384 |
| Company Name | Forestadent Bernhard Förster GmbH |
| 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 | 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 | true |
| OTC Over-The-Counter | false |
| Phone | +4972314590 |
| regulatory@forestadent.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EFORG76301011 [Primary] |
| NJM | Bracket, ceramic, orthodontic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-10-02 |
| Device Publish Date | 2019-09-24 |
| EFORG76414131 | Glam Ceramic Bracket Roth .018" mand. 3 right w. hook |
| EFORG76414111 | Glam Ceramic Bracket Roth .022" mand. 3 right w. hook |
| EFORG76414031 | Glam Ceramic Bracket Roth .018" mand. 3 right |
| EFORG76414011 | Glam Ceramic Bracket Roth .022" mand. 3 right |
| EFORG76405131 | Glam Ceramic Bracket Roth .018" max. 4+5 right w. hook |
| EFORG76405111 | Glam Ceramic Bracket Roth .022" max. 4+5 right w. hook |
| EFORG76405031 | Glam Ceramic Bracket Roth .018" max. 4+5 right |
| EFORG76405011 | Glam Ceramic Bracket Roth .022" max. 4+5 right |
| EFORG76403131 | Glam Ceramic Bracket Roth .018" max. 3 right w. hook |
| EFORG76403111 | Glam Ceramic Bracket Roth .022" max. 3 right w. hook |
| EFORG76403031 | Glam Ceramic Bracket Roth .018" max. 3 right |
| EFORG76403011 | Glam Ceramic Bracket Roth .022" max. 3 right |
| EFORG76402031 | Glam Ceramic Bracket Roth .018" max. 2 right |
| EFORG76402011 | Glam Ceramic Bracket Roth .022" max. 2 right |
| EFORG76401031 | Glam Ceramic Bracket Roth .018" max. 1 right |
| EFORG76401011 | Glam Ceramic Bracket Roth .022" max. 1 right |
| EFORG76316131 | Glam Ceramic Bracket Roth .018" mand. 5 right+left w. hook |
| EFORG76316111 | Glam Ceramic Bracket Roth .022" mand. 5 right+left w. hook |
| EFORG76316031 | Glam Ceramic Bracket Roth .018" mand. 5 right+left |
| EFORG76316011 | Glam Ceramic Bracket Roth .022" mand. 5 right+left |
| EFORG76315131 | Glam Ceramic Bracket Roth .018" mand. 4 right+left w. hook |
| EFORG76315111 | Glam Ceramic Bracket Roth .022" mand. 4 right+left w. hook |
| EFORG76315031 | Glam Ceramic Bracket Roth .018" mand. 4 right+left |
| EFORG76315011 | Glam Ceramic Bracket Roth .022" mand. 4 right+left |
| EFORG76314131 | Glam Ceramic Bracket Roth .018" mand. 3 left w. hook |
| EFORG76314111 | Glam Ceramic Bracket Roth .022" mand. 3 left w. hook |
| EFORG76314031 | Glam Ceramic Bracket Roth .018" mand. 3 left |
| EFORG76314011 | Glam Ceramic Bracket Roth .022" mand. 3 left |
| EFORG76312031 | Glam Ceramic Bracket Roth .018" mand. 1+2 right+left |
| EFORG76312011 | Glam Ceramic Bracket Roth .022" mand. 1+2 right+left |
| EFORG76305131 | Glam Ceramic Bracket Roth .018" max. 4+5 left w. hook |
| EFORG76305111 | Glam Ceramic Bracket Roth .022" max. 4+5 left w. hook |
| EFORG76305031 | Glam Ceramic Bracket Roth .018" max. 4+5 left |
| EFORG76305011 | Glam Ceramic Bracket Roth .022" max. 4+5 left |
| EFORG76303131 | Glam Ceramic Bracket Roth .018" max. 3 left w. hook |
| EFORG76303111 | Glam Ceramic Bracket Roth .022" max. 3 left w. hook |
| EFORG76303031 | Glam Ceramic Bracket Roth .018" max. 3 left |
| EFORG76303011 | Glam Ceramic Bracket Roth .022" max. 3 left |
| EFORG76302031 | Glam Ceramic Bracket Roth .018" max. 2 left |
| EFORG76302011 | Glam Ceramic Bracket Roth .022" max. 2 left |
| EFORG76301031 | Glam Ceramic Bracket Roth .018" max. 1 left |
| EFORG76301011 | Glam Ceramic Bracket Roth .022" max. 1 left |
| EFORG762T14331 | Glam Ceramic Bracket McLaughlin Bennett 5.0 .018" mand. 3 right w. hook 0° Torque |
| EFORG762T14311 | Glam Ceramic Bracket McLaughlin Bennett 5.0 .022" mand. 3 right w. hook 0° Torque |
| EFORG762T14231 | Glam Ceramic Bracket McLaughlin Bennett 5.0 .018" mand. 3 right 0° Torque |
| EFORG762T14211 | Glam Ceramic Bracket McLaughlin Bennett 5.0 .022" mand. 3 right 0° Torque |
| EFORG762T14131 | Glam Ceramic Bracket McLaughlin Bennett 5.0 .018" mand. 3 right w. hook |
| EFORG762T14111 | Glam Ceramic Bracket McLaughlin Bennett 5.0 .022" mand. 3 right w. hook |
| EFORG762T14031 | Glam Ceramic Bracket McLaughlin Bennett 5.0 .018" mand. 3 right |
| EFORG762T14011 | Glam Ceramic Bracket McLaughlin Bennett 5.0 .022" mand. 3 right |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() N.A. 77965909 3968602 Live/Registered |
Okura USA, Inc. 2010-03-23 |