Odontosurge 2
FDA 510(k) K981390 · Periogiene
510(k) numberK981390
Submission
- Device name
- Odontosurge 2
- Applicant
- Periogiene
Rockville, MD, US - Received
- April 16, 1998
- Decision date
- June 11, 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 |
| K982229 | Bi-DentEKZ · Traditional | Valley Forge Scientific Corp. | 08/13/1998SE |
Questions and answers
When was Odontosurge 2 cleared by the FDA?
Odontosurge 2 (K981390) received a 510(k) decision of Substantially Equivalent on June 11, 1998, 56 days after the submission was received.
What is the product code of K981390?
The FDA product code is EKZ – Unit, Electrosurgical, And Accessories, Dental, a Class II (moderate risk) device regulated under 21 CFR 872.4920.