| Primary Device ID | D690108160 |
| NIH Device Record Key | 0201d74b-0dcf-4076-b51f-722839f0b2af |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SSW CARBIDE |
| Version Model Number | FG-PBUR-171 |
| Catalog Number | 10816 |
| Company DUNS | 151760014 |
| Company Name | Ss White Burs, Inc. |
| Device Count | 25 |
| DM Exempt | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Phone | +1(732)905-1100 |
| customerservice@sswhitedental.com | |
| Phone | +1(732)905-1100 |
| customerservice@sswhitedental.com | |
| Phone | +1(732)905-1100 |
| customerservice@sswhitedental.com | |
| Phone | +1(732)905-1100 |
| customerservice@sswhitedental.com | |
| Phone | +1(732)905-1100 |
| customerservice@sswhitedental.com | |
| Phone | +1(732)905-1100 |
| customerservice@sswhitedental.com | |
| Phone | +1(732)905-1100 |
| customerservice@sswhitedental.com | |
| Phone | +1(732)905-1100 |
| customerservice@sswhitedental.com | |
| Phone | +1(732)905-1100 |
| customerservice@sswhitedental.com | |
| Phone | +1(732)905-1100 |
| customerservice@sswhitedental.com | |
| Phone | +1(732)905-1100 |
| customerservice@sswhitedental.com | |
| Phone | +1(732)905-1100 |
| customerservice@sswhitedental.com | |
| Phone | +1(732)905-1100 |
| customerservice@sswhitedental.com | |
| Phone | +1(732)905-1100 |
| customerservice@sswhitedental.com | |
| Phone | +1(732)905-1100 |
| customerservice@sswhitedental.com | |
| Phone | +1(732)905-1100 |
| customerservice@sswhitedental.com | |
| Phone | +1(732)905-1100 |
| customerservice@sswhitedental.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D690108160 [Unit of Use] |
| HIBCC | D690108162 [Primary] |
| EJL | BUR, DENTAL |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-02-24 |
| Device Publish Date | 2025-02-14 |
| D690100012 | FG SL CARBIDE 4 - ROLL 100 |
| D690108260 | FG CARBIDE 1557 - STERILE ROLL 25 |
| D690108250 | FG CARBIDE 557 LONG - STERILE ROLL 25 |
| D690108240 | HP CARBIDE 8 - STERILE ROLL 25 |
| D690108230 | RA CARBIDE 5 - STERILE ROLL 25 |
| D690108190 | FG CARBIDE 330 LONG - STERILE ROLL 25 |
| D690108180 | FG CARBIDE 39 - STERILE ROLL 25 |
| D690108170 | FG CARBIDE 38 - STERILE ROLL 25 |
| D690108160 | FG CARBIDE 171 - STERILE ROLL 25 |
| D690108060 | FG CARBIDE 558 - STERILE ROLL 25 |
| D690108050 | FG CARBIDE 34 - STERILE ROLL 25 |
| D690108030 | HP CARBIDE 33 1/2 - STERILE ROLL 25 |
| D690108020 | FG CARBIDE 1158 - STERILE ROLL 25 |
| D690108010 | FG CARBIDE 169 - STERILE ROLL 25 |
| D690107980 | FG CARBIDE 57 LONG - STERILE ROLL 25 |
| D690107970 | FG SL CARBIDE 1703 - STERILE ROLL 25 |
| D690107960 | GREAT WHITE GOLD CARBIDE GW340 - STERILE ROLL 25 |
| D690107480 | FG CARBIDE 1157 - STERILE ROLL 25 |
| D690107060 | GREAT WHITE GOLD CARBIDE GW8 ROUND - STERILE ROLL 25 |
| D690107050 | GREAT WHITE GOLD CARBIDE GW6 ROUND - STERILE ROLL 25 |
| D690107040 | GREAT WHITE GOLD CARBIDE GW558 - STERILE ROLL 25 |
| D690107030 | GREAT WHITE GOLD CARBIDE GW557 - STERILE ROLL 25 |
| D690107020 | GREAT WHITE GOLD CARBIDE GW556 - STERILE ROLL 25 |
| D690107010 | GREAT WHITE GOLD CARBIDE GW4 ROUND - STERILE ROLL 25 |
| D690107000 | GREAT WHITE GOLD CARBIDE GW35 - STERILE ROLL 25 |
| D690106940 | GREAT WHITE GOLD CARBIDE GW34 - STERILE ROLL 25 |
| D690106930 | GREAT WHITE GOLD CARBIDE GW2 ROUND - STERILE ROLL 25 |
| D690106920 | GREAT WHITE GOLD CARBIDE GW2 PEAR - STERILE ROLL 25 |
| D690106910 | GREAT WHITE GOLD CARBIDE GW1557 - STERILE ROLL 25 |
| D690106900 | GREAT WHITE GOLD CARBIDE GW2 - STERILE ROLL 25 |
| D690106870 | FG SL CARBIDE 1 - STERILE ROLL 25 |
| D690106850 | FG SL CARBIDE 1557 - STERILE ROLL 25 |
| D690106830 | FG SL CARBIDE 558 - STERILE ROLL 25 |
| D690106820 | FG SL CARBIDE 702 - STERILE ROLL 25 |
| D690106810 | FG SL CARBIDE 701 - STERILE ROLL 25 |
| D690106800 | FG SL CARBIDE 1558 - STERILE ROLL 25 |
| D690106790 | FG CARBIDE 57 - STERILE ROLL 25 |
| D690106780 | FG CARBIDE 56 - STERILE ROLL 25 |
| D690106770 | FG CARBIDE 37 - STERILE ROLL 25 |
| D690106760 | FG CARBIDE 33 1/2 - STERILE ROLL 25 |
| D690106740 | FG CARBIDE 170 LONG - STERILE ROLL 25 |
| D690106730 | FG CARBIDE 170 - STERILE ROLL 25 |
| D690106710 | FG CARBIDE 331 - STERILE ROLL 25 |
| D690106700 | FG CARBIDE 1/4 - STERILE ROLL 25 |
| D690105130 | FG CARBIDE 57 - STERILE ROLL 100 |
| D690105120 | FG CARBIDE 330 - STERILE ROLL 100 |
| D690105110 | FG CARBIDE 245 - STERILE ROLL 100 |
| D690105100 | FG CARBIDE 33 1/2 - STERILE ROLL 100 |
| D690105090 | FG CARBIDE 8 - STERILE ROLL 100 |
| D690103040 | HP CARBIDE 5 - STERILE ROLL 100 |