510(k) · Cleared
ClearedNobelZygoma PureSet™ Tray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nobel Biocare Services AG · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Jun 27, 2023 as substantially equivalent to K212932 (Nobel Biocare Services AG, 2021) and 1 other predicate after a 60-day review. Its family tree reaches back 11 generations to 1984.
- Decided
- Jun 27, 2023
- Review
- 60 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K844002 (1984). 17 ancestors in all. No later device cites it as a predicate yet.
- Root · 11 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 7 generations between
- 3 generations backK181075 PureSet TrayNobel Biocare AB · 2018
- 2 generations backK191475 Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate…Nobel Biocare AB · 2019
- 1 generation backK212932 Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite /…Nobel Biocare Services AG · 2021
- This deviceK231219 NobelZygoma PureSet™ TrayNobel Biocare Services AG · 2023
Show all 11 generations
- Root · 11 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 10 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- 9 generations backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- 8 generations backK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- 7 generations backK040223 Polyvac Instrument Delivery SystemSymmetry Medical USA, Inc. · 2004
- 6 generations backK120947 THS Instrument TrayHologic, Inc. · 2012
- 5 generations backK152241 Medtronic Transportation/Sterilization CassettesMedtronic Sofamor Danek USA, Inc. · 2016
- 4 generations backK163600 Kit Boxes and Kit PlatesNobel Biocare AB · 2018
- 3 generations backK181075 PureSet TrayNobel Biocare AB · 2018
- 2 generations backK191475 Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate…Nobel Biocare AB · 2019
- 1 generation backK212932 Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite /…Nobel Biocare Services AG · 2021
- This deviceK231219 NobelZygoma PureSet™ TrayNobel Biocare Services AG · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −10 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| −9 | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| −8 | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| −7 | K040223 | Polyvac Instrument Delivery System | Symmetry Medical USA, Inc. | 2004 | — |
| −6 | K120947 | THS Instrument Tray | Hologic, Inc. | 2012 | — |
| −5 | K152241 | Medtronic Transportation/Sterilization Cassettes | Medtronic Sofamor Danek USA, Inc. | 2016 | — |
| −4 | K163600 | Kit Boxes and Kit Plates | Nobel Biocare AB | 2018 | — |
| −3 | K181075 | PureSet Tray | Nobel Biocare AB | 2018 | — |
| −2 | 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 | — |
| 0 (this device) | 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 |
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? (2)
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 |
|---|---|---|---|
| * | K212932 | Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC…Summary page 5…rimary Predicate device Proprietary name: NobelSpeedy® Groovy / Brånemark System® Mk III TiUnite/Replace SelectTM TC PureSet™ Tray (K212932) Manufacturer: Nobel Biocare AB Common Name: Sterilization Wrap Classification Name: Steriliz… | 2021 |
| * | K181075 | PureSet TraySummary page 5…n Number: 21 CFR 880.6850 Device Class: II Product Code: KCT Predicate device #2 Proprietary name: Trefoil PureSet™ Tray (K181075) Manufacturer: Nobel Biocare AB Common Name: Sterilization Wrap Classification Name: Steriliz… | 2018 |
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 39 years and passes through 9 companies; a new generation was cleared every 2.2 years on median.
- None of the 17 ancestors has a recall.
- 1 other device also cites its predicate K212932.
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. 2023, 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. 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…
Read the full statement (169 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.
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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231219 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231219: NobelZygoma PureSet™ Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231219
Report an extraction error
Are you the manufacturer?
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