# K191475: Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare AB
- Decided: Aug 29, 2019 after 86 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: 9 generations back to K844002 (1984). 15 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181075: PureSet Tray, Nobel Biocare AB (2018) Summary page 5.

## Most influential descendants
- K212932: Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray (2021), 2 descendants of its own
- K260726: Straumann® ProClean™ Cassette (041.800 ; 041.801) (2026), 0 descendants of its own
- K231144: Washtrays (2024), 0 descendants of its own
- K231219: NobelZygoma PureSet™ Tray (2023), 0 descendants of its own

## 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. The 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 pouch or sterilization wrap. Sterilization validations for the worst-case PureSet Tray included surgical/prosthetic instruments such as torque wrenches, implant drivers, direction indicators, drills, screw taps, screw driver and irrigation needles. The PureSet Trays were validated for a maximum load of 1635 grams (Trefoil PureSet Tray), 1082 grams (NobelActive/NobelParallel CC PureSet Tray), 945 grams (NobelReplace CC PureSet Tray), 454 grams (Nobel Biocare N1™ PureSet) and 486 grams (Prosthetic PureSet). Method: Steam Sterilization (Moist Heat Sterilization) Cycle: Dynamic-Air-Removal (fractionated vacuum); Gravity-Displacement Temperature: 132°C (270°F); 132°C (270°F) Exposure time for a single-use pouched device: 4 minutes (full-cycle); 15 minutes (full-cycle) Minimum drying times: 20 minutes; 30 minutes

Source page: https://510kreport.com/device/K191475
Methodology: https://510kreport.com/methodology