# K190665: Neodent Instrument Kit Cases

- Pathway: 510(k) (Traditional)
- Applicant: Jjgc Industria E Comercio DE Materiais Dentarios S.A.
- Decided: Dec 23, 2019 after 283 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: 9 generations back to K844002 (1984). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171713: Neodent Instrument Kits, Jjgc Industria E Comercio DE Materiais Dentarios S.A. (2018) Summary page 5.

## Indications for use
Indications for Use for GM Zygomatic 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 Neodent Instrument Kit Cases are intended for sterilization of non-porous loads. The GM Zygomatic Surgical Kit Case maximum load weight is 220 grams. Neodent Instrument Kit Cases should not to be stacked during sterilization. Indications for Use for GM Helix LG 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 LG Compact Kit Case and the instruments is 297.3 g. The weight of the empty kit case is 236 g. Neodent Instrument Kit Cases should not to be stacked during sterilization.

Source page: https://510kreport.com/device/K190665
Methodology: https://510kreport.com/methodology