# K171713: Neodent Instrument Kits

- Pathway: 510(k) (Traditional)
- Applicant: Jjgc Industria E Comercio DE Materiais Dentarios S.A.
- Decided: Apr 5, 2018 after 300 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: 8 generations back to K844002 (1984). 11 ancestors in all.
18 later devices descend from it; 3 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160730: Instrument kits, Anthogyr (2017) Summary page 4.

## Most influential descendants
- K182865: Neodent Instruments Kits (2019), 13 descendants of its own
- K192670: Neodent Instrument Kit Cases (2019), 5 descendants of its own
- K201688: S.I.N. Instrument Kits (2020), 4 descendants of its own
- K201878: ST-Z5 (2021), 2 descendants of its own
- K212404: S.I.N. Instrument Kits (2021), 1 descendant of its own

## Indications for use
Neodent Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instrument Kits are intended to allow sterilization of the enclosed medical devices. Neodent Instrument Kits 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 Kits are intended for sterilization of non-porous loads. The GM/WS Surgical Kit Case maximum load weight is 125 grams. The GM Surgical Kit Case maximum load weight is 113 grams. Neodent Instrument Kits are recommended not to be stacked during sterilization.

Source page: https://510kreport.com/device/K171713
Methodology: https://510kreport.com/methodology