# K192670: Neodent Instrument Kit Cases

- Pathway: 510(k) (Traditional)
- Applicant: Jjgc Industria E Comercio DE Materiais Dentarios S.A.
- Decided: Dec 18, 2019 after 84 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: 10 generations back to K844002 (1984). 13 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182865: Neodent Instruments Kits, Jjgc Industria E Comercio DE Materiais Dentarios S.A. (2019) Summary page 5.

## Most influential descendants
- K203618: Neodent EasyGuide Kit Cases (2021), 1 descendant of its own
- K241492: Guided Surgery Kit Cases (2024), 0 descendants of its own
- K223662: Neodent Implant System - Helix Short Surgical Kit Cases (2023), 0 descendants of its own
- K214051: Neodent Implant System-Helix NGM Compact Surgical Kit Cases (2022), 0 descendants of its own
- K202515: NUVO Implant System – NUVO Instrument Kit Cases (2020), 0 descendants of its own

## Indications for use
Indications for Use for GM Surgical Kit Case: Neodent Instrument Kit Cases are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instrument Kit Cases are intended to allow sterilization of the enclosed medical devices. Neodent Instrument Kit Cases require the use of FDA cleared wrap to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist heat (steam) sterilized using one of the following cycles: Fractionated vacuum (pre-vacuum) – Exposure at 132 °C for 4 minutes, 20-minute dry time. Gravity displacement – Exposure at 132 °C for 15 minutes, 40-minute dry time. Neodent Instrument Kit Cases are intended for sterilization of non-porous loads. The combined weight of the GM Surgical Kit Case and the associated instruments is 613.1 g. The weight of the empty Kit Case is 510 grams. Neodent Instrument Kit Cases should not to be stacked during sterilization. Indications for Use for GM Helix Compact Surgical Kit Case: Neodent Instrument Kit Cases are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instrument Kit Cases are intended to allow sterilization of the enclosed medical devices. Neodent Instrument Kit Cases require the use of FDA cleared wrap to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist heat (steam) sterilized using one of the following cycles: Fractionated vacuum (pre-vacuum) – Exposure at 132 °C for 4 minutes, 20-minute dry time Gravity displacement – Exposure at 132 °C for 15 minutes, 20-minute dry time. Neodent Instrument Kit Cases are intended for sterilization of non-porous loads. The combined weight of the GM Helix Compact Surgical Kit Case and the associated instruments is 308.2 g. The weight of the empty Kit Case is 231 grams. Neodent Instrument Kit Cases should not to be stacked during sterilization.

Source page: https://510kreport.com/device/K192670
Methodology: https://510kreport.com/methodology