Discus Dental LLC
Ontario, CA, US
DISCUS DENTAL, LLC appears in FDA device records in Ontario, CA. FDA records list 15 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 15 510(k) clearances for Discus Dental LLC between 2002 and 2010. The busiest year on record is 2010, with 4. The most recent is 2010, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2002 | 1 |
| 2003 | 2 |
| 2004 | 3 |
| 2005 | 2 |
| 2007 | 2 |
| 2009 | 1 |
| 2010 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K102639 | SL3 | GEX | Substantially Equivalent | |
| K101612 | ZEN CORDLESS PROPHY SYSTEM | EKX | Substantially Equivalent | |
| K101215 | NUANCE | EBF | Substantially Equivalent | |
| K093208 | SIMPLISEAL | KIF | Substantially Equivalent | |
| K092417 | INSIGHT ULTRASONIC INSERTS | ELC | Substantially Equivalent | |
| K073518 | FLASHLITE REBEL* | EBZ | Substantially Equivalent | |
| K062176 | RELIEF ACP ORAL CARE GEL | LBH | Substantially Equivalent | |
| K052090 | SPLASH! IMPRESSION MATERIAL DEVICE | ELW | Substantially Equivalent | |
| K051776 | PROTEGE ULTRASONIC INSERT | ELC | Substantially Equivalent | |
| K033785 | PROACTIVE CARE PROPHYLAXIS PASTE WITH FLUORIDE | EJR | Substantially Equivalent | |
| K040053 | PRECISION VPS IMPRESSION MATERIAL | ELW | Substantially Equivalent | |
| K033381 | DISCHEM CHEMICAL PROPORTIONING & DISPENSING SYSTEM FOR USE WITH CETYLCIDE-G CONCENTRATE AND DILUENT, AQUARIUS MODEL | MED | Substantially Equivalent | |
| K030776 | MEGA BITE REGISTRATION - DENTAL BITE REGISTRATION MATERIAL | ELW | Substantially Equivalent | |
| K023748 | FLASH-LITE II LED DENTAL CURING LIGHT | EBZ | Substantially Equivalent | |
| K022184 | FLASH-LITE LED DENTAL CURING LIGHT | EBZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2031532 | 1000582314 | DISCUS DENTAL, LLC | 1700 A South Baker Ave, Ontario, CA 91761 US | 2026 | and 3 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KHRAbsorber, Saliva, Paper
- EIFAccessories, Retractor, Dental
- EBZActivator, Ultraviolet, For Polymerization
- EJRAgent, Polishing, Abrasive, Oral Cavity
- GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered
- EFNCotton, Roll
- EIEDam, Rubber
- EKXHandpiece, Direct Drive, Ac-Powered
- EEGHeat Source For Bleaching Teeth
- ELWMaterial, Impression
- EBHMaterial, Impression Tray, Resin
- EBFMaterial, Tooth Shade, Resin
- OGTOral Irrigation Kit
- GEXPowered Laser Surgical Instrument
- KIFResin, Root Canal Filling
- ELCScaler, Ultrasonic
- IWSShield, Eye, Radiological
- KPYShield, Protective, Personnel
- MEDSterilant, Medical Devices
- JEQToothbrush, Powered
- EFSUnit, Oral Irrigation
- LBHVarnish, Cavity
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0425-2015 | 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. | Class II | Terminated | |
| Z-1186-2013 | SL3 SOFT-TISSUE Laser (Model LR2002); Manuf: Discus Dental, LLC, 8550 Higuera Street, Culver City CA 90232. The SL3 is a soft-tissue diode laser intended to be used for dental procedures | The firm is initiating this recall of the SL3 Soft Tissue Laser equipped with a fiber optic Unifiber system which contains a fragile glass filament because the fiber broke near the hand piece. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain