510(k) · Cleared
ClearedGuided Surgery Kit Cases
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
JJGC Indústria e Comércio de Materiais Dentários S.A. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Aug 23, 2024 as substantially equivalent to K203618 (Jjgc Industria E Comercio DE Materiais Dentarios S.A., 2021) after an 87-day review. Its family tree reaches back 12 generations to 1984.
- Decided
- Aug 23, 2024
- Review
- 87 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K844002 (1984). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 12 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 8 generations between
- 3 generations backK182865 Neodent Instruments KitsJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2019
- 2 generations backK192670 Neodent Instrument Kit CasesJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2019
- 1 generation backK203618 Neodent EasyGuide Kit CasesJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2021
- This deviceK241492 Guided Surgery Kit CasesJJGC Indústria e Comércio de Materiais Dentários S.A. · 2024
Show all 12 generations
- Root · 12 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 11 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- 10 generations backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- 9 generations backK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- 8 generations backK023658 Sterilization Cases and TraysCarr Metal Products, Inc. · 2003
- 7 generations backK052992 Conmed Linvatec Instrument Sterilization TrayConmed Linvatec · 2006
- 6 generations backK142519 InterActive Complete Surgical TrayImplant Direct Sybron Manufacturing, LLC · 2015
- 5 generations backK160730 Instrument kitsAnthogyr · 2017
- 4 generations backK171713 Neodent Instrument KitsJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2018
- 3 generations backK182865 Neodent Instruments KitsJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2019
- 2 generations backK192670 Neodent Instrument Kit CasesJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2019
- 1 generation backK203618 Neodent EasyGuide Kit CasesJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2021
- This deviceK241492 Guided Surgery Kit CasesJJGC Indústria e Comércio de Materiais Dentários S.A. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −11 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| −10 | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| −9 | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| −8 | K023658 | Sterilization Cases and Trays | Carr Metal Products, Inc. | 2003 | — |
| −7 | K052992 | Conmed Linvatec Instrument Sterilization Tray | Conmed Linvatec | 2006 | — |
| −6 | K142519 | InterActive Complete Surgical Tray | Implant Direct Sybron Manufacturing, LLC | 2015 | — |
| −5 | K160730 | Instrument kits | Anthogyr | 2017 | — |
| −4 | K171713 | Neodent Instrument Kits | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2018 | — |
| −3 | K182865 | Neodent Instruments Kits | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2019 | — |
| −2 | K192670 | Neodent Instrument Kit Cases | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2019 | — |
| −1 | K203618 | Neodent EasyGuide Kit Cases | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2021 | — |
| 0 (this device) | K241492 | Guided Surgery Kit Cases | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 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 |
|---|---|---|---|
| * | K203618 | Neodent EasyGuide Kit CasesSummary page 6…nd Nuvo CF Guided Surgery Kit Cases 510(k) Summary - K241492 Predicate Device(s) Primary Predicate: K203618 – Neodent EasyGuide Kit Cases (JJGC Indústria e Comércio de Materiais Dentários S.A) Reference Devices:… | 2021 |
| † | K182865 | Neodent Instruments Kits | 2019 |
| † | K223662 | Neodent Implant System - Helix Short Surgical Kit Cases | 2023 |
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 40 years and passes through 10 companies; a new generation was cleared every 2.0 years on median.
- None of the 15 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. 2024, 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?
Zirconia Guided Surgery Kit Cases: Zirconia Guided Surgery Kit Cases are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Zirconia Guided Surgery Kit Cases are intended to allow sterilization of the enclosed medical devices. Zirconia Guided Surgery Kit Cases require the use of FDA-cleared wrap to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap…
Read the full statement (345 words)
Zirconia Guided Surgery Kit Cases:
Zirconia Guided Surgery Kit Cases are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Zirconia Guided Surgery Kit Cases are intended to allow sterilization of the enclosed medical devices. Zirconia Guided Surgery Kit Cases require the use of FDA-cleared wrap to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist heat (steam) sterilized using one of the following cycles: Dynamic Air Removal (pre-vacuum) – Exposure at 132°C for 4 minutes, 20-minute dry time. Gravity displacement – Exposure at 132°C for 15 minutes, 20-minute dry time. Zirconia Guided Surgery Kit Cases are intended for sterilization of non-porous loads. The combined weight of the Zirconia Guided Surgery Kit Case and the associated instruments is 342.2 g. The weight of the empty Kit is 236.8 grams. Zirconia Guided Surgery Kit Case are recommended not to be stacked during sterilization.
Nuvo CF Guided Surgery Kit Cases:
Nuvo CF Guided Surgery Kit Cases are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Nuvo CF Guided Surgery Kit Cases are intended to allow sterilization of the enclosed medical devices. Nuvo CF Guided Surgery Kit Cases require the use of FDA-cleared wrap to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist heat (steam) sterilized using one of the following cycles: Fractionated vacuum (pre-vacuum): exposure at 132°C for 4 minutes, drying for 20 minutes. Gravity displacement: exposure at 132°C for 15 minutes, drying for 30 minutes. Nuvo CF Guided Surgery Kit Cases are intended for sterilization of non-porous loads. The combined weight of the Nuvo CF Guided Surgery Kit Cases and the associated instruments is approximately 693 g. The weight of the empty case is 487 grams. Nuvo CF Guided Surgery Kit Cases are not recommended to be stacked during sterilization.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241492 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241492: Guided Surgery Kit Cases.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241492
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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