FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ODYSSEY 2.4G, DENLASER ELITE, MODEL 002-00050
K Number: K050453
·
Decision May 27, 2005
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
62
Review Days
94
Basic Information
- Device Name
- ODYSSEY 2.4G, DENLASER ELITE, MODEL 002-00050
- K Number
- K050453
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- IVOCLAR VIVADENT, INC.
- Date Received
- February 22, 2005
- Decision Date
- May 27, 2005
- Product Code
- GEX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GEX), ordered by most recent decision date.
AviClear Laser System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Pastelle
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SurgiLight 1470 Diode Laser System (Model:Halo)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AuroLase® System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Diode laser device (RF3120-BI)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by IVOCLAR VIVADENT, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K153753 | TelioCAD Multi | Apr 12, 2016 | Substantially Equivalent |
| K143575 | Accu-Dent XD Tray, Accu-Dent XD Syringe | Apr 3, 2015 | Substantially Equivalent |
| K132984 | SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S | Jan 14, 2014 | Substantially Equivalent |
| K111958 | TETRIC EVOCERAM BULK FILL | Oct 14, 2011 | Substantially Equivalent |
| K110756 | BLUEPHASE STYLE | Aug 29, 2011 | Substantially Equivalent |
| K103556 | IPS E.MAX CAD CRYSTALL / CONNECT AND IPS E.MAX CAD CRYSTAL / ADD-ON CONNECT (FOR CAD-ON TECHNIQUE) | Apr 13, 2011 | Substantially Equivalent |
| K103528 | IPS EMPRESS DIRECT FLOW | Feb 25, 2011 | Substantially Equivalent |
| K103391 | IVOBASE HYBRID, IVOBASE HIGH IMPACT | Feb 17, 2011 | Substantially Equivalent |
| K103379 | TELIO CS INLAY & TELIO CS ONLAY | Feb 14, 2011 | Substantially Equivalent |
| K093708 | TELIO CAD | Mar 10, 2010 | Substantially Equivalent |