Bi-Dent
FDA 510(k) K982229 · Valley Forge Scientific Corp.
510(k) numberK982229
Submission
- Device name
- Bi-Dent
- Applicant
- Valley Forge Scientific Corp.
Oaks, PA, US - Received
- May 15, 1998
- Decision date
- August 13, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| K981390 | Odontosurge 2EKZ · Traditional | Periogiene | 06/11/1998SE |
More from Periogiene
| 510(k) | Device | Decision |
|---|---|---|
| K050364 | Malis 2000 Bipolar Electrosurgical SystemGEI · Special | 03/09/2005SE |
| K042604 | Vally Forge Scientific Malis Bipolar Disposable Finger Operated Electrosurgical…GEI · Special | 10/22/2004SE |
| K032601 | Stryker Interventional Pain RF GeneratorGXD · Traditional | 04/01/2004SE |
| K033499 | Malis Irrigation Module 1000GEI · Special | 11/28/2003SE |
| K973554 | Valley Forge Bipolar Ball Tip ElectrodeJOS · Traditional | 12/19/1997SE |
| K971986 | Valley Forge Bipolar LoopHGI · Traditional | 08/26/1997SE |
| K964143 | Mini-Symm Bipolar CoagulatorGEI · Traditional | 01/09/1997SE |
| K955764 | Valley Forge Biploar LoopGEI · Traditional | 03/01/1996SE |
| K955346 | VFS - 300 Bipolar Electrosurgery SystemGEI · Traditional | 12/08/1995SE |
| K951985 | Precision Bipolar CoagulatorGEI · Traditional | 05/23/1995SE |
Questions and answers
When was Bi-Dent cleared by the FDA?
Bi-Dent (K982229) received a 510(k) decision of Substantially Equivalent on August 13, 1998, 90 days after the submission was received.
What is the product code of K982229?
The FDA product code is EKZ – Unit, Electrosurgical, And Accessories, Dental, a Class II (moderate risk) device regulated under 21 CFR 872.4920.