Manufacturer registered with FDA
SS White Burs LLC
Lakewood, NJ, United States. Lists 9 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 9
- Brands and models
- 10
- 510(k) clearances
- 12008–2008
- Markets registered in
- 112,976 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2000–2026
Registered in 11 markets
Where regulators' registries name SS White Burs LLC as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | SS White Burs LLC | 1 clearances | 2008–2008 | Below |
| European Union | EUDAMED | Manufacturer | SS White Burs LLC | 2,573 | — | Pure Global AI |
| Colombia | INVIMA | Registration holder | SS WHITE BURS INCS.S. WHITE BURS, INC. · SS. WHITE BURS INC. · +2 | 229 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | SS WHITE BURS LLC | 132 | 2005–2026 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | S.S. WHITE BURS, INC.Ss White Burs, Inc. | 10 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SS WHITE BURS INC.S.S. WHITE BURS, INC. · S.S. White Burs, Inc. | 9 | 2006–2025 | Pure Global AI |
| South Korea | MFDS | Manufacturer | SS White Burs, Inc.,SS White Burs, Inc.^ · S.S. White Burs, Inc. · +2 | 8 | 2001–2020 | Pure Global AI |
| Australia | TGA | Manufacturer | SS White Burs LLCSS White Burs Inc | 6 | 2010–2025 | Pure Global AI |
| Israel | AMAR | Manufacturer | SS White Burs, Inc. | 5 | — | Pure Global AI |
| China | NMPA | Registration holder | 豪孚迪集团艾斯怀特有限责任公司SS White Burs LLC | 3 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | S. S. WHITE BURS, INC. | 1 | 2011–2011 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What SS White Burs LLC currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Lister | BLACK DIAMOND, GREAT WHITE Z, PIRANHA, REVELATION | 1992 |
| Abrasive PointEHL · Class 1 | Polishing & prophylaxis | Lister | Jazz Polisher | 2007 |
| Polishing Agent StripEHM · Class 1 | Polishing & prophylaxis | Lister | Strip, Polishing Agent - Jazz Finishing Strip | 2022 |
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Lister | Syringe, Periodontic, Endodontic, Irrigating - SS Bioceramic Root Canal White Automix Tips | 2023 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | SS WHITE CARBIDE BURS | 1992 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Lister | Gutta-Percha - SSW Gutta Percha, EXACTFLOW, EXACTTAPER, EXACTTAPERH, EXACTGUIDE | 2012 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Lister | Point, Paper, Endodontic - SSW Paper Point, EXACTFLOW, EXACTTAPER, EXACTTAPERH, EXACTGUIDE | 2012 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | File, Pulp, Endodontic - DCTAPER, DCTAPERH, EXACTFLOW, EXACTFLOWH, EXACTTAPER, EXACTTAPERH, EXACTGUIDE, EXACTTAPERH DCFile, Pulp, Endodontic - DCTAPER, DCTAPERH, EXACTFLOWH, EXACTTAPER, EXACTTAPERH | 2012 |
| Root Canal Filling ResinKIF · Class 2 | Root canal filling materials | Lister | SS White Bioceramic Root Canal Sealer | 2019 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
SS White Burs LLC lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Paxmed International (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 21 Aug 2012 | K113568 | MTA-FILLAPEX | Paxmed International | KIF Root Canal Filling Resin |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SS WHITE BURS LLCFDA reg. 2245654 | LAKEWOOD, NJ, United States | Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 2245654). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.