Macan Model MC-4A Dental Electrosurgical Unit
FDA 510(k) K052622 · Macan Engineering Co.
510(k) numberK052622
Submission
- Device name
- Macan Model MC-4A Dental Electrosurgical Unit
- Applicant
- Macan Engineering Co.
Chicago, IL, US - Received
- September 23, 2005
- Decision date
- December 9, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| 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 |
| K981390 | Odontosurge 2EKZ · Traditional | Periogiene | 06/11/1998SE |
More from Periogiene
| 510(k) | Device | Decision |
|---|---|---|
| K050735 | MC6AEKZ · Traditional | 05/23/2005SE |
Questions and answers
When was Macan Model MC-4A Dental Electrosurgical Unit cleared by the FDA?
Macan Model MC-4A Dental Electrosurgical Unit (K052622) received a 510(k) decision of Substantially Equivalent on December 9, 2005, 77 days after the submission was received.
What is the product code of K052622?
The FDA product code is EKZ – Unit, Electrosurgical, And Accessories, Dental, a Class II (moderate risk) device regulated under 21 CFR 872.4920.