# K142519: InterActive Complete Surgical Tray

- Pathway: 510(k) (Traditional)
- Applicant: Implant Direct Sybron Manufacturing, LLC
- Decided: Apr 15, 2015 after 219 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: 6 generations back to K844002 (1984). 9 ancestors in all.
30 later devices descend from it; 5 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052992: Conmed Linvatec Instrument Sterilization Tray, Conmed Linvatec (2006) Summary page 5.
- K012105: Polyvac Surgical Instrument Delivery System, Symmetry Medical, Inc. (2002) Summary page 5.
- K990761: Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette, Tuttnauer U.S.A Co, Ltd. (1999) Summary page 5.
- K980065: C/T Med-Systems Cassette System, C/T Med System, Ltd. (1998) Summary page 5.

## Most influential descendants
- K160730: Instrument kits (2017), 20 descendants of its own
- 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

## Indications for use
The InterActive Complete Surgical Tray is designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and transport the instruments between uses. The tray is to be enclosed in an FDA cleared steam sterilizable wrap and sterilized in an FDA cleared sterilizer for one of the following cycles: (1) Prevaccum Steam – At 1320C for 4 minutes with a 20 minutes dry time. (2) Gravity Steam - At 1320C for 15 minutes with a 30 minutes dry time. - The trays are intended for sterilization of non-porous loads. - The trays are recommended not to be stacked during sterilization. - The Complete Surgical Tray represents the worst case validated load due to the number of components (45 instruments) and the weight of 608.05 grams. - Implant Direct Sybron Manufacturing LLC does not make any lumen claims for the Interactive Complete Surgical Tray. - The tray will be marketed in following variations. Device Model Name Max no. of Instruments Weight of each tray with instruments (gms.) CST 45 608.05 ICST 34 467.26 IBST 18 453.59 IST 0 404.37

Source page: https://510kreport.com/device/K142519
Methodology: https://510kreport.com/methodology