Data / Medical devices / United States / Discus Dental, LLC
Discus Dental, LLC: FDA-registered device maker in Ontario, CA, United States, 1 510(k) clearance
Discus Dental, LLC is registered with the FDA (registration 2031532) in Ontario, CA, United States. It lists 13 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 10, 2007. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2031532
- FEI number
- 1000582314
- Address
- 1700 A South Baker Ave, Ontario, CA, United States, 91761
- Owner or operator
- Philips Medical Systems International BV (9005541)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- March 31, 1994
- Registered through
- 2026
- Brand names listed
- AirFloss, AirFloss Fill and Charge Station, AirFloss Pro, AirFloss Ultra, Cheek Retractor, Cotton Roll, EVA Tray, Face Bib and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Absorber, Saliva, Paper | KHR | 1 | Repackager or relabeler | accessdata.fda.gov |
| Accessories, Retractor, Dental | EIF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Cotton, Roll | EFN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Dam, Rubber | EIE | 1 | Manufacturer | accessdata.fda.gov |
| Heat Source For Bleaching Teeth | EEG | 1 | Manufacturer | accessdata.fda.gov |
| Material, Impression Tray, Resin | EBH | 1 | Manufacturer | accessdata.fda.gov |
| Oral Irrigation Kit | OGT | 1 | Repackager or relabeler | accessdata.fda.gov |
| Shield, Eye, Radiological | IWS | 1 | Repackager or relabeler | accessdata.fda.gov |
| Shield, Protective, Personnel | KPY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Toothbrush, Powered | JEQ | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Unit, Oral Irrigation | EFS | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Varnish, Cavity | LBH | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| January 10, 2007 | K062176 | RELIEF ACP ORAL CARE GEL | LBH | Substantially Equivalent | Discus Dental, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 24, 2014 | 69625 | Class II | Terminated | Relief ACP Oral Care Gel intended to relieve discomfort from dentin sensitivity. Sold separately in single, single syringe, 4 packs, 6 packs and in teeth whitening kits | Product sold after April 1, 2014 were inadvertently filled with hydrogen peroxide teeth whitening gel (6% concentration as dispensed) on one side of the dual barrel syringe instead of the intended component (phosphate gel). Consequently, use of this product by patients may result in a neutral effect or increased sensitivity. | accessdata.fda.gov |
Compare with other makers
- All makers of Apparatus, Suction, Single Patient Use, Portable, Nonpowered
- All makers of Cotton, Roll
- All makers of Oral Irrigation Kit
- All makers of Shield, Protective, Personnel
- All makers of Unit, Oral Irrigation
- All makers of Material, Impression Tray, Resin
Updated November 24, 2014. 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.