Strobex Ultron Electrosurge-Dental Unit
FDA 510(k) K850666 · Ipco Corp.
510(k) numberK850666
Submission
- Device name
- Strobex Ultron Electrosurge-Dental Unit
- Applicant
- Ipco Corp.
White Plains, NY, US - Received
- February 20, 1985
- Decision date
- May 29, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EKZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K213477 | Root ZX3EKZ · Traditional | J. Morita USA, Inc. | 08/03/2022SE |
| K071632 | Perfect Tissue Contouring System IIEKZ · Abbreviated | Coltene/Whaledent, Inc. | 10/18/2007SE |
| K063468 | The Fugo Blade for DentistryEKZ · Traditional | Medisurg , Ltd. | 04/18/2007SE |
| K052622 | Macan Model MC-4A Dental Electrosurgical UnitEKZ · Traditional | Macan Engineering Co. | 12/09/2005SE |
| K050735 | MC6AEKZ · Traditional | Macan Engineering Co. | 05/23/2005SE |
| K023672 | X O Odontosurge 4EKZ · Traditional | Xo Care A/S | 04/29/2003SE |
| K020080 | Bonart ART-E1 Electrosurgery UnitEKZ · Traditional | Diagnostic Data, Inc. | 02/19/2002SE |
| K001560 | Odontosurge 3EKZ · Traditional | Odonto-Wave | 08/24/2000SE |
| K000768 | Wallach Quantum 500 Electrosurgical GeneratorEKZ · Traditional | Wallach Surgical Devices, Inc. | 04/11/2000SE |
| K982229 | Bi-DentEKZ · Traditional | Valley Forge Scientific Corp. | 08/13/1998SE |
More from Valley Forge Scientific Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K871270 | Perform Denture Base ResinEBF · Traditional | 05/29/1987SE |
| K850906 | Tactile Plus Dental ElevatorsEMJ · Traditional | 04/12/1985SE |
| K842837 | Safe & Soft Maxi ShiledsHHD · Traditional | 10/15/1984SE |
| K842836 | Safe & Soft Mini Pads & Maxi PadsHHD · Traditional | 10/15/1984SE |
| K842838 | Safe & Soft Panty ShieldsHHD · Traditional | 10/05/1984SE |
| K841953 | Ultra Shield BriefsEYQ · Traditional | 07/19/1984SE |
| K840755 | Minigard Disposable LinersEYQ · Traditional | 04/13/1984SE |
| K840754 | Maxishield Incontinence Care SystemEYQ · Traditional | 04/13/1984SE |
| K840753 | Ambeze Disposable Incontinence PantsEYQ · Traditional | 04/13/1984SE |
| K800293 | File, Pulp CanalEKS · Traditional | 02/19/1980SE |
Questions and answers
When was Strobex Ultron Electrosurge-Dental Unit cleared by the FDA?
Strobex Ultron Electrosurge-Dental Unit (K850666) received a 510(k) decision of Substantially Equivalent on May 29, 1985, 98 days after the submission was received.
What is the product code of K850666?
The FDA product code is EKZ – Unit, Electrosurgical, And Accessories, Dental, a Class II (moderate risk) device regulated under 21 CFR 872.4920.