Data / Medical devices / United States / SS White Burs LLC
SS White Burs LLC: FDA-registered device maker in Lakewood, NJ, United States, 1 510(k) clearance
SS White Burs LLC is registered with the FDA (registration 2245654) in Lakewood, NJ, United States. It lists 9 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 21, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2245654
- Address
- 1145 Towbin Ave, Lakewood, NJ, United States, 08701
- Owner or operator
- SS White Burs LLC (2245654)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- July 31, 1992
- Registered through
- 2026
- Brand names listed
- BLACK DIAMOND, GREAT WHITE Z, PIRANHA, REVELATION, File, Pulp, Endodontic - DCTAPER, DCTAPERH, EXACTFLOW, EXACTFLOWH, EXACTTAPER, EXACTTAPERH, EXACTGUIDE, EXACTTAPERH DC, File, Pulp, Endodontic - DCTAPER, DCTAPERH, EXACTFLOWH, EXACTTAPER, EXACTTAPERH, Gutta-Percha - SSW Gutta Percha, EXACTFLOW, EXACTTAPER, EXACTTAPERH, EXACTGUIDE, Jazz Polisher, Point, Paper, Endodontic - SSW Paper Point, EXACTFLOW, EXACTTAPER, EXACTTAPERH, EXACTGUIDE, SS WHITE CARBIDE BURS, SS White Bioceramic Root Canal Sealer and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bur, Dental | EJL | 1 | Manufacturer | accessdata.fda.gov |
| File, Pulp Canal, Endodontic | EKS | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Gutta-Percha | EKM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Instrument, Diamond, Dental | DZP | 1 | Repackager or relabeler | accessdata.fda.gov |
| Point, Abrasive | EHL | 1 | Repackager or relabeler | accessdata.fda.gov |
| Point, Paper, Endodontic | EKN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Resin, Root Canal Filling | KIF | 2 | Repackager or relabeler | accessdata.fda.gov |
| Strip, Polishing Agent | EHM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Syringe, Periodontic, Endodontic, Irrigating | EIC | 1 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 21, 2012 | K113568 | MTA-FILLAPEX | KIF | Substantially Equivalent | Paxmed International | accessdata.fda.gov |
Compare with other makers
- All makers of Instrument, Diamond, Dental
- All makers of Point, Abrasive
- All makers of Point, Paper, Endodontic
- All makers of Syringe, Periodontic, Endodontic, Irrigating
- All makers of Bur, Dental
- All makers of File, Pulp Canal, Endodontic
Updated August 21, 2012. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.