# K231219: NobelZygoma PureSet™ Tray

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare Services AG
- Decided: Jun 27, 2023 after 60 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). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212932: Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray, Nobel Biocare Services AG (2021) Summary page 5.
- K181075: PureSet Tray, Nobel Biocare AB (2018) Summary page 5.

## Indications for use
The Nobel Biocare PureSet™ Trays are used in healthcare facilities to store and organize Nobel Biocare surgical/prosthetic instruments and components during cleaning/sterilization and during implant/prosthetic treatment. Nobel Biocare PureSet™ Trays are not intended on their own to maintain sterility; they are intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization container, sterilization pouch or sterilization wrap. Sterilization validations for the worst-case PureSet™ Tray included surgical instruments such as torque wrenches, implant drivers, direction indicators, drills, screw taps, screwdrivers, and irrigation needles. The PureSet™ Trays were validated for a maximum load of 1635 grams (Trefoil™ PureSet™ Tray), 1122 grams (NobelActive® / NobelParallel™ CC PureSet™ Tray), 1063 grams (NobelReplace® CC PureSet™ Tray), 454 grams (Nobel Biocare N1™ PureSet™ Tray), 486 grams (Prosthetic PureSet™ Tray), 1143 grams (NobelActive® Guided PureSet™ Tray), 1146 grams (NobelParallel™ CC Guided PureSet™ Tray), 1176 grams (NobelReplace® CC Guided PureSet™ Tray), and 1035 grams (NobelSpeedy® Groovy® / Brånemark System® Mk III TiUnite / Replace SelectTM TC PureSet™ Tray) and 1202 grams (NobelZygoma PureSet™ Tray).

Source page: https://510kreport.com/device/K231219
Methodology: https://510kreport.com/methodology