# K071632: Perfect Tissue Contouring System II

- Pathway: 510(k) (Abbreviated)
- Applicant: Coltene/Whaledent, Inc.
- Decided: Oct 18, 2007 after 126 days
- Product code: EKZ (Unit, Electrosurgical, And Accessories, Dental)
- Device class: 2
- Regulation: 21 CFR 872.4920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K850666 (1985). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K850666: Strobex Ultron Electrosurge-Dental Unit, Ipco Corp. (1985) Summary page 1.

## Indications for use
The PerFect® TCS II is intended to cut or remove soft tissue or to control bleeding during dental and periodontal surgical procedures in the oral cavity.

Source page: https://510kreport.com/device/K071632
Methodology: https://510kreport.com/methodology