# K223662: Neodent Implant System - Helix Short Surgical Kit Cases

- Pathway: 510(k) (Traditional)
- Applicant: Jjgc Industria E Comercio DE Materiais Dentarios S.A.
- Decided: Apr 20, 2023 after 135 days
- Product code: KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K844002 (1984). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192670: Neodent Instrument Kit Cases, Jjgc Industria E Comercio DE Materiais Dentarios S.A. (2019) Summary page 7.

## Indications for use
The HS Surgical Kit Cases are indicated for the organization of surgical and/or prosthetic instruments during sterilization, storage, and transport. Use of this product facilitates the storage and organization of instruments during and after surgical procedures. Neodent instrument kit cases are intended to allow sterilization of the medical devices included. Neodent instrument kit cases must be wrapped in FDA-approved materials to maintain the sterility of the devices included. The kits should be placed in an FDA-approved sterilization wrap for the indicated cycles and sterilized by moist heat (steam) using one of the following cycles: Dynamic Air Removal (Pre-Vacuum): exposure at 132°C for 4 minutes, drying for 30 minutes. Gravity displacement: exposure at 132°C for 15 minutes, drying for 50 minutes. Neodent instrument kit cases are intended for sterilization of non-porous fillers. The combined weight of the HS Surgical Kit case and associated instruments is 302.88 grams. The weight of the empty case is approximately 214.85 grams. Neodent instrument kit cases should not be stacked during sterilization.

Source page: https://510kreport.com/device/K223662
Methodology: https://510kreport.com/methodology