510(k) · Cleared
ClearedAnthogyr INTEGRAL Guided Surgery Cassettes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Anthogyr · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Dec 22, 2023 as substantially equivalent to K203753 (Straumann USA, LLC, 2021) after an 84-day review. Its family tree reaches back 11 generations to 1984.
- Decided
- Dec 22, 2023
- Review
- 84 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
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 backK180791 Straumann BLX Surgical CassetteInstitut Straumann AG · 2018
- 2 generations backK191522 Straumann Modular CassetteInstitut Straumann AG · 2019
- 1 generation backK203753 Straumann Surgical CassettesStraumann USA, LLC · 2021
- This deviceK233264 Anthogyr INTEGRAL Guided Surgery CassettesAnthogyr · 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 backK180791 Straumann BLX Surgical CassetteInstitut Straumann AG · 2018
- 2 generations backK191522 Straumann Modular CassetteInstitut Straumann AG · 2019
- 1 generation backK203753 Straumann Surgical CassettesStraumann USA, LLC · 2021
- This deviceK233264 Anthogyr INTEGRAL Guided Surgery CassettesAnthogyr · 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 | K180791 | Straumann BLX Surgical Cassette | Institut Straumann AG | 2018 | — |
| −2 | K191522 | Straumann Modular Cassette | Institut Straumann AG | 2019 | — |
| −1 | K203753 | Straumann Surgical Cassettes | Straumann USA, LLC | 2021 | — |
| 0 (this device) | K233264 | Anthogyr INTEGRAL Guided Surgery Cassettes | Anthogyr | 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? (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 |
|---|---|---|---|
| * | K203753 | Straumann Surgical CassettesSummary page 6…Anthogyr INTEGRAL Guided Surgery Cassettes 510(k) Summary K233264 5.3 Predicate Device(s) Primary Predicate: x K203753 Straumann Surgical Cassettes Product Code(s): KCT Device Classification: II Classification name Sterilizati… | 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 39 years and passes through 11 companies; a new generation was cleared every 2.2 years on median.
- None of the 17 ancestors has a recall.
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 Anthogyr Cassettes are designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and protect the instruments that are sterilized by healthcare provider. The cassette is to be enclosed in an FDA cleared steam sterilizable pouch. The cassettes are not intended on their own to maintain sterility. The cycle of sterilization, for Anthogyr INTEGRAL Guided Surgery Cassettes, uses pre-vacuum steam: 132 °C (270º F)…
Read the full statement (125 words)
The Anthogyr Cassettes are designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and protect the instruments that are sterilized by healthcare provider. The cassette is to be enclosed in an FDA cleared steam sterilizable pouch. The cassettes are not intended on their own to maintain sterility.
The cycle of sterilization, for Anthogyr INTEGRAL Guided Surgery Cassettes, uses pre-vacuum steam: 132 °C (270º F) during 4 minutes with 30 minutes drying time.
Anthogyr INTEGRAL Guided Surgery Cassettes have been validated for a maximum load of with the associated instrument. The worst-case recommended load is: 886 g.
The device dimension of Anthogyr INTEGRAL Guided Surgery Cassettes is 290x176x62 mm.
The cassettes are not intended to be stacked during sterilization process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233264 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233264: Anthogyr INTEGRAL Guided Surgery Cassettes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233264
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