# K052622: Macan Model MC-4A Dental Electrosurgical Unit

- Pathway: 510(k) (Traditional)
- Applicant: Macan Engineering Co.
- Decided: Dec 9, 2005 after 77 days
- Product code: EKZ (Unit, Electrosurgical, And Accessories, Dental)
- Device class: 2
- Regulation: 21 CFR 872.4920
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K950239 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050735: MC6A, Macan Engineering Co. (2005) Summary page 1.

## Recalls of this device
- Apr 5, 2006 · Not classified · Z-0810-06: The product label fails to warn users to use the device on patients with shielded pacemakers only.

## Indications for use
Soft tissue management within the oral cavity to address the indications for incision, excision and coagulation to induce hemostasis in intra-oral soft tissue.

Source page: https://510kreport.com/device/K052622
Methodology: https://510kreport.com/methodology