# K983105: CCS; Computer Controlled Syringe, Model #CCS-100, CCS; Cartridge Holder (Replacements), Model # CCS-100-01

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Midwest
- Decided: Mar 8, 1999 after 185 days
- Product code: EJI (Syringe, Cartridge)
- Device class: 2
- Regulation: 21 CFR 872.6770
- 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 K961648 (1996). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961648: The Wand, Spintech, Inc. (1996) Summary page 1.

## Most influential descendants
- K081694: Denjector (2008), 0 descendants of its own
- K992404: The Wand (2000), 0 descendants of its own

## Indications for use
The Computer Controlled Syringe is an electronic programmable device indicated for the injection of local anesthetics for infiltration and nerve block anesthesia administered prior to, or in conjunction with, dental procedures.

Source page: https://510kreport.com/device/K983105
Methodology: https://510kreport.com/methodology