510(k) · Cleared
ClearedLiteSet Trays
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nobel Biocare AB · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Sep 8, 2026 as substantially equivalent to K202524 (Implant Direct Sybron Manufacturing, LLC, 2021) after a 270-day review. Its family tree reaches back 9 generations to 1984.
- Decided
- Sep 8, 2026
- Review
- 270 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K844002 (1984). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 5 generations between
- 3 generations backK142519 InterActive Complete Surgical TrayImplant Direct Sybron Manufacturing, LLC · 2015
- 2 generations backK200858 Mini Sterilizable TrayImplant Direct Sybron Manufacturing, LLC · 2020 · Recalled
- 1 generation backK202524 Standard Sterilizable TrayImplant Direct Sybron Manufacturing, LLC · 2021
- This deviceK253988 LiteSet TraysNobel Biocare AB · 2026
Show all 9 generations
- Root · 9 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 8 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- 7 generations backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- 6 generations backK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- 5 generations backK023658 Sterilization Cases and TraysCarr Metal Products, Inc. · 2003
- 4 generations backK052992 Conmed Linvatec Instrument Sterilization TrayConmed Linvatec · 2006
- 3 generations backK142519 InterActive Complete Surgical TrayImplant Direct Sybron Manufacturing, LLC · 2015
- 2 generations backK200858 Mini Sterilizable TrayImplant Direct Sybron Manufacturing, LLC · 2020 · Recalled
- 1 generation backK202524 Standard Sterilizable TrayImplant Direct Sybron Manufacturing, LLC · 2021
- This deviceK253988 LiteSet TraysNobel Biocare AB · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −8 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| −7 | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| −6 | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| −5 | K023658 | Sterilization Cases and Trays | Carr Metal Products, Inc. | 2003 | — |
| −4 | K052992 | Conmed Linvatec Instrument Sterilization Tray | Conmed Linvatec | 2006 | — |
| −3 | K142519 | InterActive Complete Surgical Tray | Implant Direct Sybron Manufacturing, LLC | 2015 | — |
| −2 | K200858 | Mini Sterilizable Tray | Implant Direct Sybron Manufacturing, LLC | 2020 | 1 |
| −1 | K202524 | Standard Sterilizable Tray | Implant Direct Sybron Manufacturing, LLC | 2021 | — |
| 0 (this device) | K253988 | LiteSet Trays | Nobel Biocare AB | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KCT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KCT device
- #1 K214041 Aesculap AICON Containerscore 18.1 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K202524 | Standard Sterilizable TraySummary page 7…Page 1 of 10 1.3 Predicate Device Predicate device Proprietary name: Standard Sterilizable Tray (K202524) Manufacturer: Implant Direct Sybron Manufacturing LLC Common Name: Sterilization wrap Classi… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 42 years and passes through 8 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 12 ancestors has a recall of any class.
- 1 other device also cites its predicate K202524.
How does its category compare?
All KCT devicesKCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · KCT
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KCT
205in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KCT
17in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KCT
50in 2025
MAUDE reports naming product code KCT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 199 | 0 | 2 |
| 2008 | 6 | 182 | 0 | 8 |
| 2009 | 6 | 89 | 0 | 5 |
| 2010 | 12 | 202 | 1 | 3 |
| 2011 | 6 | 117 | 2 | 3 |
| 2012 | 10 | 236 | 0 | 2 |
| 2013 | 8 | 131 | 1 | 6 |
| 2014 | 11 | 169 | 1 | 5 |
| 2015 | 15 | 151 | 0 | 6 |
| 2016 | 12 | 182 | 3 | 16 |
| 2017 | 10 | 211 | 1 | 3 |
| 2018 | 15 | 192 | 0 | 22 |
| 2019 | 18 | 187 | 0 | 15 |
| 2020 | 14 | 134 | 0 | 66 |
| 2021 | 18 | 185 | 1 | 26 |
| 2022 | 11 | 137 | 17 | 8 |
| 2023 | 10 | 94 | 0 | 30 |
| 2024 | 8 | 106 | 0 | 18 |
| 2025 | 11 | 205 | 0 | 50 |
| 2026 | 9 | 122 | 0 | — |
What is it indicated for?
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. *…
Read the full statement (254 words)
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
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K253988 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253988: LiteSet Trays.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253988
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026