# K203618: Neodent EasyGuide Kit Cases

- Pathway: 510(k) (Traditional)
- Applicant: Jjgc Industria E Comercio DE Materiais Dentarios S.A.
- Decided: Mar 9, 2021 after 88 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.
1 later device descends from it; 1 cites it directly.
0 of 16 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 5.

## Most influential descendants
- K241492: Guided Surgery Kit Cases (2024), 0 descendants of its own

## Indications for use
Indications for Use for GM EasyGuide Surgical Kit Case Narrow/Regular Diam Implants: Neodent Instruments Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instruments Kits are intended to allow sterilization of the enclosed medical devices. Neodent Instruments Kits require the use of FDA-cleared wrap to maintain the sterility of enclosed devices. The kits are to be enclose 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 minutes dry time. Gravity displacement - Exposure at 132 °C for 15 minutes, 20-minutes dry-time. Neodent Instruments Kits are intended for sterilization of non-porous loads. The combined weight of GM EasyGuide Surgical Kit Case Narrow/Regular Diam Implants and the associated instruments is 310,18 g. The weight of the empty Kit Case is 263,63 g Neodent GM EasyGuide Kit Cases should not be stacked during sterilization Indications for Use for GM EasyGuide Surgical Kit Case Regular/Large Diam Implants: Neodent Instruments Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instruments Kits are intended to allow sterilization of the enclosed medical devices. Neodent Instruments Kits require the use of FDA-cleared wrap to maintain the sterility of 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 minutes dry-time. Gravity displacement - Exposure at 132 °C for 15 minutes, 45-minutes dry-time. Neodent Instruments Kits are intended for sterilization of non-porous loads. The combined weight of the GM EasyGuide Surgical Kit Case Regular/Large Diam Implants and the associated instruments is 346,45 g. The weight of the empty Kit Case is 264,12 g. Neodent GM EasyGuide Kit Cases should not be stacked during sterilization.

Source page: https://510kreport.com/device/K203618
Methodology: https://510kreport.com/methodology