# K160730: Instrument kits

- Pathway: 510(k) (Traditional)
- Applicant: Anthogyr
- Decided: Apr 27, 2017 after 407 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: 7 generations back to K844002 (1984). 10 ancestors in all.
20 later devices descend from it; 2 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142519: InterActive Complete Surgical Tray, Implant Direct Sybron Manufacturing, LLC (2015) Summary page 4.

## Most influential descendants
- K171713: Neodent Instrument Kits (2018), 18 descendants of its own
- 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

## Indications for use
The instrument kits are designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and protect the instruments that are sterilized by healthcare provider. The cassette is to be enclosed in an FDA cleared steam sterilizable pouch. The cassettes are not intended on their own to maintain sterility. The cycle of sterilization is: Pre-vacuum steam: 134 °C during 3 minutes with 16 minutes drying time Anthogyr does not make any lumen claims for the instrument kits. The Axiom range surgery kit represents the worst case validated load due to the number of components (34 instruments). The cassettes are not intended to be stacked during sterilization process.

Source page: https://510kreport.com/device/K160730
Methodology: https://510kreport.com/methodology