# K163600: Kit Boxes and Kit Plates

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare AB
- Decided: Jan 22, 2018 after 397 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). 13 ancestors in all.
18 later devices descend from it; 2 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152241: Medtronic Transportation/Sterilization Cassettes, Medtronic Sofamor Danek USA, Inc. (2016) Summary page 4.

## Most influential descendants
- K180791: Straumann BLX Surgical Cassette (2018), 11 descendants of its own
- K212281: Surgical Trays (2022), 5 descendants of its own
- K181075: PureSet Tray (2018), 5 descendants of its own
- K191475: Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate (2019), 4 descendants of its own
- K220791: Surgical and Prosthetic Trays (2022), 2 descendants of its own

## Indications for use
The Nobel Biocare Kit Boxes are used in healthcare facilities to organize, enclose, sterilize, transport, and store medical devices between surgical uses. The Nobel Biocare Kit Boxes are not intended on their own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap. Sterilization validations for the worst-case Kit Box included surgical instruments such as torque wrenches, implant drivers, direction indicators, drills, screw taps, screw driver and irrigation needles. The Kit Boxes were validated for a maximum load of 469 grams including kit box and instruments.

Source page: https://510kreport.com/device/K163600
Methodology: https://510kreport.com/methodology