510(k) · Cleared
ClearedNobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC 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 Dec 18, 2021 as substantially equivalent to K181075 (Nobel Biocare AB, 2018) and 1 other predicate after a 94-day review. Its family tree reaches back 10 generations to 1984. 2 later devices descend from it.
- Decided
- Dec 18, 2021
- Review
- 94 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K844002 (1984). 16 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 6 generations between
- 3 generations backK163600 Kit Boxes and Kit PlatesNobel Biocare AB · 2018
- 2 generations backK181075 PureSet TrayNobel Biocare AB · 2018
- 1 generation backK191475 Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate…Nobel Biocare AB · 2019
- This deviceK212932 Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite /…Nobel Biocare Services AG · 2021
- Descendant · cites it directly · 0 of its ownK231144 WashtraysDentsply Sirona · 2024
- Descendant · cites it directly · 0 of its ownK231219 NobelZygoma PureSet™ TrayNobel Biocare Services AG · 2023
Show all 10 generations
- Root · 10 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 9 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- 8 generations backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- 7 generations backK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- 6 generations backK040223 Polyvac Instrument Delivery SystemSymmetry Medical USA, Inc. · 2004
- 5 generations backK120947 THS Instrument TrayHologic, Inc. · 2012
- 4 generations backK152241 Medtronic Transportation/Sterilization CassettesMedtronic Sofamor Danek USA, Inc. · 2016
- 3 generations backK163600 Kit Boxes and Kit PlatesNobel Biocare AB · 2018
- 2 generations backK181075 PureSet TrayNobel Biocare AB · 2018
- 1 generation backK191475 Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate…Nobel Biocare AB · 2019
- This deviceK212932 Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite /…Nobel Biocare Services AG · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −9 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| −8 | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| −7 | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| −6 | K040223 | Polyvac Instrument Delivery System | Symmetry Medical USA, Inc. | 2004 | — |
| −5 | K120947 | THS Instrument Tray | Hologic, Inc. | 2012 | — |
| −4 | K152241 | Medtronic Transportation/Sterilization Cassettes | Medtronic Sofamor Danek USA, Inc. | 2016 | — |
| −3 | K163600 | Kit Boxes and Kit Plates | Nobel Biocare AB | 2018 | — |
| −2 | K181075 | PureSet Tray | Nobel Biocare AB | 2018 | — |
| −1 | K191475 | Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic… | Nobel Biocare AB | 2019 | — |
| 0 (this device) | K212932 | Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace… | Nobel Biocare Services AG | 2021 | — |
| +1 | K231144 | Washtrays | Dentsply Sirona | 2024 | — |
| +1 | 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 |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K181075 | PureSet TraySummary page 5…Page 1 of 11 3. Predicate Device Primary Predicate Device: • Proprietary Name: NobelActive / NobelParallel CC PureSet Tray (K181075) • Common Name: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories • Manufacturer: Nobel Biocare Ser… | 2018 |
| * | K191475 | Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray…Summary page 5…ification Name: Sterilization Wrap • Device Class: II • Product Code: KCT Predicate Device #2: • Proprietary Name: Nobel Biocare N1™ PureSet Tray (K191475) • Common Name: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories • Manufacturer: Nobel Biocare Ser… | 2019 |
What descends from it? (2)
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 37 years and passes through 9 companies; a new generation was cleared every 2.3 years on median.
- None of the 16 ancestors has a recall.
- Of its descendants, K231144 (Dentsply Sirona, 2024) has gone furthest, with 0 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. 2021, 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?
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.…
Read the full statement (163 words)
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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212932 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212932: Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC 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/K212932
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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