| Primary Device ID | D690149180 |
| NIH Device Record Key | d3f6fa05-10c3-4e98-9668-a97aaeec97e5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SSW CARBIDE GREAT WHITE |
| Version Model Number | FG-PBUR-GW340 |
| Catalog Number | 14918 |
| Company DUNS | 151760014 |
| Company Name | Ss White Burs, Inc. |
| Device Count | 10 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D690149180 [Unit of Use] |
| HIBCC | D690149182 [Primary] |
| EJL | BUR, DENTAL |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-02-27 |
| Device Publish Date | 2025-02-19 |
| D690107090 | GREAT WHITE GOLD CARBIDE GWSL 4 ROUND - STERILE ROLL 25 |
| D690107080 | GREAT WHITE GOLD CARBIDE GWSL 6 ROUND - STERILE ROLL 25 |
| D690107070 | GREAT WHITE GOLD CARBIDE GWSL 557 - STERILE ROLL 25 |
| D690101380 | GREAT WHITE ULTRA CARBIDE OCCLUSAL DEPTH CUTTER GWUDC2 2MM - STERILE ROLL 25 |
| D690143920 | T10 METAL CUTTER CARBIDE - 10 PACK |
| D690136430 | T10 METAL CUTTER CARBIDE - 100 PACK |
| D690130960 | GREAT WHITE GOLD CARBIDE GW2 SHORT SHANK - BULK 100 |
| D690130950 | GREAT WHITE GOLD CARBIDE GW2 - BULK 100 |
| D690130940 | GREAT WHITE GOLD CARBIDE GW1 SHORT - BULK 100 |
| D690130930 | GREAT WHITE GOLD CARBIDE GW1 - BULK 100 |
| D690130920 | GREAT WHITE GOLD CARBIDE GW1557 - BULK 100 |
| D690130910 | GREAT WHITE GOLD CARBIDE GW557 - BULK 100 |
| D690130900 | GREAT WHITE GOLD CARBIDE GW330 - BULK 100 |
| D690130890 | GREAT WHITE GOLD CARBIDE GW245 - BULK 100 |
| D690130880 | GREAT WHITE GOLD CARBIDE GW6 ROUND - BULK 100 |
| D690130870 | GREAT WHITE GOLD CARBIDE GW4 ROUND - BULK 100 |
| D690130860 | GREAT WHITE GOLD CARBIDE GW2 ROUND - BULK 100 |
| D690109330 | GREAT WHITE ULTRA CARBIDE OCCLUSAL DEPTH CUTTER GWUDC1 1.5MM - STERILE ROLL 25 |
| D690109280 | GREAT WHITE GOLD CARBIDE GWSL 2 ROUND - STERILE ROLL 25 |
| D690647672 | GREAT WHITE 4R SL SAMPLE - 1 PACK |
| D690647592 | GREAT WHITE 557 SAMPLE - 1 PACK |
| D690647582 | GREAT WHITE 2 ROUND SAMPLE - 1 PACK |
| D690647572 | GREAT WHITE 2 SAMPLE - 1 PACK |
| D690182542 | GW ULTRA 847-018 PRO SAMPLE |
| D690182532 | GW ULTRA 856-018 PRO SAMPLE |
| D690182492 | GREAT WHITE #2-PROF.SAMP.GOLD |
| D690182482 | GREAT WHITE #1-PROF.SAMP.GOLD |
| D690182452 | FG GW701 PRO SAMPLE |
| D690182422 | FG GW557SL PRO SAMPLE |
| D690182402 | FG GW557 PRO SAMPLE |
| D690182332 | FG GW330 PRO SAMPLE |
| D690182282 | FG GW4 ROUND PRO SAMPLE |
| D6901822450 | GREAT WHITE GOLD CARBIDE GW702 - 5 PACK |
| D690182240 | GREAT WHITE GOLD CARBIDE GW702 - 10 PACK |
| D6901822350 | GREAT WHITE GOLD CARBIDE GW701 - 5 PACK |
| D690182230 | GREAT WHITE GOLD CARBIDE GW701 - 10 PACK |
| D6901822250 | GREAT WHITE GOLD CARBIDE GW558 - 5 PACK |
| D690182220 | GREAT WHITE GOLD CARBIDE GW558 - 10 PACK |
| D6901822150 | GREAT WHITE GOLD CARBIDE GW1557 - 5 PACK |
| D690182210 | GREAT WHITE GOLD CARBIDE GW1557 - 10 PACK |
| D6901821950 | GREAT WHITE GOLD CARBIDE GW557 SHORT SHANK - 5 PACK |
| D690182190 | GREAT WHITE GOLD CARBIDE GW557 SHORT SHANK - 10 PACK |
| D6901821850 | GREAT WHITE GOLD CARBIDE GW557 - 5 PACK |
| D690182180 | GREAT WHITE GOLD CARBIDE GW557 - 10 PACK |
| D6901821750 | GREAT WHITE GOLD CARBIDE GW556 - 5 PACK |
| D690182170 | GREAT WHITE GOLD CARBIDE GW556 - 10 PACK |
| D6901821650 | GREAT WHITE GOLD CARBIDE GW37 - 5 PACK |
| D690182160 | GREAT WHITE GOLD CARBIDE GW37 - 10 PACK |
| D6901821550 | GREAT WHITE GOLD CARBIDE GW35 - 5 PACK |
| D690182150 | GREAT WHITE GOLD CARBIDE GW35 - 10 PACK |