510(k) · Cleared
ClearedNobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate
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 Aug 29, 2019 as substantially equivalent to K181075 (Nobel Biocare AB, 2018) after an 86-day review. Its family tree reaches back 9 generations to 1984. 4 later devices descend from it.
- Decided
- Aug 29, 2019
- Review
- 86 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K844002 (1984). 15 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 5 generations between
- 3 generations backK152241 Medtronic Transportation/Sterilization CassettesMedtronic Sofamor Danek USA, Inc. · 2016
- 2 generations backK163600 Kit Boxes and Kit PlatesNobel Biocare AB · 2018
- 1 generation backK181075 PureSet TrayNobel Biocare AB · 2018
- This deviceK191475 Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate…Nobel Biocare AB · 2019
- Descendant · cites it directly · 2 of its ownK212932 Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite /…Nobel Biocare Services AG · 2021
- Descendant · cites it directly · 0 of its ownK260726 Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AG · 2026
- Descendant · 2 generations on · 0 of its ownK231144 WashtraysDentsply Sirona · 2024
- Descendant · 2 generations on · 0 of its ownK231219 NobelZygoma PureSet™ TrayNobel Biocare Services AG · 2023
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 backK040223 Polyvac Instrument Delivery SystemSymmetry Medical USA, Inc. · 2004
- 4 generations backK120947 THS Instrument TrayHologic, Inc. · 2012
- 3 generations backK152241 Medtronic Transportation/Sterilization CassettesMedtronic Sofamor Danek USA, Inc. · 2016
- 2 generations backK163600 Kit Boxes and Kit PlatesNobel Biocare AB · 2018
- 1 generation backK181075 PureSet TrayNobel Biocare AB · 2018
- This deviceK191475 Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate…Nobel Biocare AB · 2019
Most influential descendants
Showing 4 of 4 · See all- K212932Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC…Nobel Biocare Services AG · 2021 · cites it directly2descendants
- K260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AG · 2026 · cites it directly0descendants
- K231144WashtraysDentsply Sirona · 2024 · 2 generations on0descendants
- K231219NobelZygoma PureSet™ TrayNobel Biocare Services AG · 2023 · 2 generations on0descendants
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 | K040223 | Polyvac Instrument Delivery System | Symmetry Medical USA, Inc. | 2004 | — |
| −4 | K120947 | THS Instrument Tray | Hologic, Inc. | 2012 | — |
| −3 | K152241 | Medtronic Transportation/Sterilization Cassettes | Medtronic Sofamor Danek USA, Inc. | 2016 | — |
| −2 | K163600 | Kit Boxes and Kit Plates | Nobel Biocare AB | 2018 | — |
| −1 | K181075 | PureSet Tray | Nobel Biocare AB | 2018 | — |
| 0 (this device) | K191475 | Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic… | Nobel Biocare AB | 2019 | — |
| +1 | K212932 | Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace… | Nobel Biocare Services AG | 2021 | — |
| +1 | K260726 | Straumann® ProClean™ Cassette (041.800 ; 041.801) | Institut Straumann AG | 2026 | — |
| +2 | K231144 | Washtrays | Dentsply Sirona | 2024 | — |
| +2 | K231219 | NobelZygoma PureSet™ Tray | Nobel Biocare Services AG | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K181075 | PureSet TraySummary page 5…Device Classification Class II Classification Panel Dental Devices Panel III. Predicate Device Predicate Nobel Biocare - PureSet Tray (K181075) The following device are referenced in the Substantial Equivalence Discussion: Device Name… | 2018 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 35 years and passes through 8 companies; a new generation was cleared every 2.2 years on median.
- None of the 15 ancestors has a recall.
- Of its descendants, K212932 (Nobel Biocare Services AG, 2021) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K181075.
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. 2019, 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 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…
Read the full statement (159 words)
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191475 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191475: Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191475
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026