# K253988: LiteSet Trays

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare AB
- Decided: Sep 8, 2026 after 270 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). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202524: Standard Sterilizable Tray, Implant Direct Sybron Manufacturing, LLC (2021) Summary page 7.

## Indications for use
The LiteSet Trays are intended to organize, store, and sterilize instrumentation or components used for dental implant surgical and prosthetic procedures. The tray is to be enclosed in an FDA cleared steam sterilizable pouch or wrap and sterilized in an FDA cleared sterilizer for one of the following cycles: (1) Prevacuum Steam — At 132°C for 4 minutes with a 20 minutes dry time. (2) Gravity Steam — At 132°C for 15 minutes with a 20 minutes dry time. * The tray is intended for sterilization of non-porous loads. * Do not stack trays during sterilization. * Nobel Biocare does not make any lumen claims for the LiteSet Trays Model # Model Name Max # of Instruments Max Load (g) Vent-to-Volume Ratio (in⁻¹) 302492 NobelActive®/NobelParallel™ CC LiteSet™ Tray 62 498.00 0.0314 302494 NobelReplace® CC LiteSet™ Tray 51 437.00 0.0320 302496 Nobel Biocare N1™ LiteSet™ Tray 23 294.00 0.0447 302498 Prosthetic LiteSet™ Tray 21 318.00 0.0454 302500 Polo Multi-unit Abutment LiteSet™ Tray 50 254.65 0.0453 302503 NobelSpeedy®/Brånemark/Replace Select™ TC LiteSet™ Tray 47 462.00 0.0324 302533 NobelActive®/NobelParallel™ S LiteSet™ Tray 51 488.00 0.0317 302535 NobelReplace® S LiteSet™ Tray 43 432.00 0.0320 302595 Conical Connection Scan Body - Singles LiteSet™ Tray 18 235.41 0.0448 302596 Conical Connection Scan Body - Bridge LiteSet™ Tray 26 240.42 0.0446 302597 External hex Scan Body LiteSet™ Tray 14 231.93 0.0447 302598 Tri-channel Scan Body LiteSet™ Tray 18 238.97 0.0448 302599 Nobel Biocare N1™ system Scan Body LiteSet™ Tray 18 220.38 0.0448 302600 On1™ base Scan Body LiteSet™ Tray 14 233.02 0.0447

Source page: https://510kreport.com/device/K253988
Methodology: https://510kreport.com/methodology