# K202515: NUVO Implant System – NUVO Instrument Kit Cases

- Pathway: 510(k) (Traditional)
- Applicant: Jjgc Industria E Comercio DE Materiais Dentarios S.A.
- Decided: Nov 24, 2020 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: 11 generations back to K844002 (1984). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 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 4.

## Indications for use
Indications for Use for Drill Stop Pre-Mounted Kit and Drill Stop Kit: Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Instrument Kits are intended to allow sterilization of the enclosed medical devices. 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, 30-minute dry time Gravity displacement – Exposure at 132 °C for 15 minutes, 30-minute dry time. Instrument Kits are intended for sterilization of nonporous loads. The combined weight of the Kit and the associated instruments is 194,90 grams. The weight of the empty Kit is 189,12 grams. Instrument Kits are recommended not to be stacked during sterilization.

Source page: https://510kreport.com/device/K202515
Methodology: https://510kreport.com/methodology