# K030111: Diamondcoat Ultrasonic Inserts

- Pathway: 510(k) (Special)
- Applicant: Dentsply International
- Decided: Feb 7, 2003 after 25 days
- Product code: ELC (Scaler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 872.4850
- 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 K923639 (1992). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923639: Diamond Coated Dental Inserts, Dentsply Intl. (1992) Summary page 1.

## Most influential descendants
- K192033: Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip (2020), 0 descendants of its own

## Indications for use
Used for: (1) Removal of extremely tenacious deposits of calculus in both non-surgical and surgically exposed cases; (2) Removal of overhangs and re-contouring of dental restorations (amalgam, gold, composite, acrylic and porcelain) in both non-surgical and surgically exposed cases; and (3) Soft tissue debridement--removal of tissue tags, particularly in intrabony lesions.

Source page: https://510kreport.com/device/K030111
Methodology: https://510kreport.com/methodology