510(k) · Cleared
ClearedAutoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prismatik Dentalcraft, Inc. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Mar 21, 2025 as substantially equivalent to K180791 (Institut Straumann AG, 2018) after a 205-day review. Its family tree reaches back 9 generations to 1984.
- Decided
- Mar 21, 2025
- Review
- 205 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. 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 backK152241 Medtronic Transportation/Sterilization CassettesMedtronic Sofamor Danek USA, Inc. · 2016
- 2 generations backK163600 Kit Boxes and Kit PlatesNobel Biocare AB · 2018
- 1 generation backK180791 Straumann BLX Surgical CassetteInstitut Straumann AG · 2018
- This deviceK242564 Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit…Prismatik Dentalcraft, Inc. · 2025
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 backK180791 Straumann BLX Surgical CassetteInstitut Straumann AG · 2018
- This deviceK242564 Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit…Prismatik Dentalcraft, Inc. · 2025
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 | K180791 | Straumann BLX Surgical Cassette | Institut Straumann AG | 2018 | — |
| 0 (this device) | K242564 | Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell… | Prismatik Dentalcraft, Inc. | 2025 | — |
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? (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 |
|---|---|---|---|
| * | K180791 | Straumann BLX Surgical CassetteSummary page 5…terilization Wrap Regulation Number: 21 CFR 880.6850 Regulatory Class: Class II Product Code: KCT III. Predicate Device Predicate 510(k) #: K180791 Predicate Trade Name: Straumann® BLX Surgical Cassette Classification Name: Sterilization Wrap Regulation Nu… | 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 41 years and passes through 10 companies; a new generation was cleared every 3.1 years on median.
- None of the 15 ancestors has a recall.
- 4 other devices also cite its predicate K180791.
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. 2025, 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 Autoclavable Cassettes are used in healthcare facilities to organize surgical and prosthetic instruments during sterilization, storage, and transport during and after surgical uses. The Autoclavable Cassettes are not intended to maintain sterility; they are intended to be used in conjunction with a legally marketed, validated sterilization wrap to maintain the sterility of the enclosed devices. Sterilization parameters: Pre-vacuum steam: 132°C (270°…
Read the full statement (116 words)
The Autoclavable Cassettes are used in healthcare facilities to organize surgical and prosthetic instruments during sterilization, storage, and transport during and after surgical uses. The Autoclavable Cassettes are not intended to maintain sterility; they are intended to be used in conjunction with a legally marketed, validated sterilization wrap to maintain the sterility of the enclosed devices.
Sterilization parameters:
Pre-vacuum steam: 132°C (270° F) for 4 minutes with 30 minutes drying time.
Sterilization validations for the worst-case Autoclavable Cassette included cassette and instruments. The Autoclavable Cassettes are validated for a maximum load of 641 grams for Glidewell HT™ Implant Guided Surgical Kit, 476 grams for Glidewell HT™ Implant Surgical Kit, and 192 grams for Glidewell™ Prosthetic Kit.
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/K242564 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242564: Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242564
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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