Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of PhilipsLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Discus Dental with 15 510(k) clearances and 2 device recalls. The most recent is a device recall dated Oct 24, 2014: Relief ACP Oral Care Gel intended to relieve discomfort from dentin sensitivity. Sold s….
| Oct 24, 2014 | Relief ACP Oral Care Gel intended to relieve discomfort from dentin sensitivity. Sold separately in single, single syringe, 4 packs, 6 packClass II · Product sold after April 1, 2014 were inadvertently filled with hydrogen peroxide teeth whitening gel (6% concentration | Device recalls |
| Jul 21, 2011 | SL3 SOFT-TISSUE Laser (Model LR2002); Manuf: Discus Dental, LLC, 8550 Higuera Street, Culver City CA 90232. The SL3 is a soft-tissue diodClass II · The firm is initiating this recall of the SL3 Soft Tissue Laser equipped with a fiber optic Unifiber system which conta | Device recalls |
| Dec 1, 2010 | SL3K102639 · GEX | 510(k) clearances |
| Jun 30, 2010 | ZEN CORDLESS PROPHY SYSTEMK101612 · EKX | 510(k) clearances |
| May 12, 2010 | NUANCEK101215 · EBF | 510(k) clearances |
| Feb 12, 2010 | SIMPLISEALK093208 · KIF | 510(k) clearances |
| Dec 11, 2009 | INSIGHT ULTRASONIC INSERTSK092417 · ELC | 510(k) clearances |
| Dec 20, 2007 | FLASHLITE REBEL*K073518 · EBZ | 510(k) clearances |
| Jan 10, 2007 | RELIEF ACP ORAL CARE GELK062176 · LBH | 510(k) clearances |
| Aug 5, 2005 | SPLASH! IMPRESSION MATERIAL DEVICEK052090 · ELW | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
