# K192033: Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip

- Pathway: 510(k) (Traditional)
- Applicant: Bennett Jacoby, Dds, Ms, Inc.
- Decided: Jun 9, 2020 after 315 days
- Product code: DZI (Drill, Bone, Powered)
- Device class: 2
- Regulation: 21 CFR 872.4120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K862807 (1986). 36 ancestors in all.
No later device cites it as a predicate yet.
1 of 37 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113152: Ultrasonic Surgery Machine, Dmetec.Co., Ltd. (2012) Summary page 4.
- K030111: Diamondcoat Ultrasonic Inserts, Dentsply International (2003) Summary page 4.
- K153743: Piezosurgery Plus, Mectron S.P.A. (2016) Summary page 4.

## Indications for use
The Contour P-Insert System (CPIS) is an accessory attachment to the Dmetec Surgystar piezosurgery system. It is used by dental professionals during treatment of periodontal disease and oral surgery for the following intended uses: 1. Surgical procedures including osteotomy, osteoplasty, periodontal surgery and implantation. 2. Soft tissue debridement and removal, particularly in intrabony lesions.

Source page: https://510kreport.com/device/K192033
Methodology: https://510kreport.com/methodology