# K182865: Neodent Instruments Kits

- Pathway: 510(k) (Traditional)
- Applicant: Jjgc Industria E Comercio DE Materiais Dentarios S.A.
- Decided: May 7, 2019 after 208 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.
13 later devices descend from it; 4 cite it directly.
0 of 26 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 7.

## Most influential descendants
- K192670: Neodent Instrument Kit Cases (2019), 5 descendants of its own
- K201688: S.I.N. Instrument Kits (2020), 4 descendants of its own
- K212404: S.I.N. Instrument Kits (2021), 1 descendant of its own
- K203618: Neodent EasyGuide Kit Cases (2021), 1 descendant of its own
- K241492: Guided Surgery Kit Cases (2024), 0 descendants of its own

## Indications for use
Indications for Use for GM/WS Surgical Kit Case: 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 combined weight of the GM/WS Surgical Kit Case and the associated instruments is 674.5 g. The weight of the empty Kit Case is 507 grams. Neodent Instrument Kits are recommended not to be stacked during sterilization. Indications for Use for GM Prosthetic Kit Case: 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 combined weight of the GM Prosthetic Kit Case and the associated instruments is 250.5 g. The weight of the empty Kit Case is 210 grams. Neodent Instrument Kits are recommended not to be stacked during sterilization. Indications for Use for GM Try-In Kit Case: 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 require the use of FDA-cleared wrap to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilizable 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 combined weight of the GM Try-In Kit Case and the associated instruments is 212.6 g. The weight of the empty Kit Case is 195 grams. Neodent Instrument Kits are recommended not to be stacked during sterilization. Indications for Use for GM Guided Surgery Kit Case: 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, 40-minute dry time. Neodent Instrument Kits are intended for sterilization of non-porous loads. The combined weight of the GM Guided Surgery Surgical Kit Case and the associated instruments is 728.4 g. The weight of the empty Kit Case is 567 grams. Neodent Instrument Kits are recommended not to be stacked during sterilization.

Source page: https://510kreport.com/device/K182865
Methodology: https://510kreport.com/methodology