510(k) · Cleared
ClearedNeodent Instrument Kit Cases
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jjgc Industria E Comercio DE Materiais Dentarios S.A. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Dec 18, 2019 as substantially equivalent to K182865 (Jjgc Industria E Comercio DE Materiais Dentarios S.A., 2019) after an 84-day review. Its family tree reaches back 10 generations to 1984. 5 later devices descend from it.
- Decided
- Dec 18, 2019
- Review
- 84 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K844002 (1984). 13 ancestors in all. 5 later devices descend from it, 4 citing it directly.
- Root · 10 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 6 generations between
- 3 generations backK160730 Instrument kitsAnthogyr · 2017
- 2 generations backK171713 Neodent Instrument KitsJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2018
- 1 generation backK182865 Neodent Instruments KitsJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2019
- This deviceK192670 Neodent Instrument Kit CasesJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2019
- Descendant · cites it directly · 1 of its ownK203618 Neodent EasyGuide Kit CasesJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2021
- Descendant · 2 generations on · 0 of its ownK241492 Guided Surgery Kit CasesJJGC Indústria e Comércio de Materiais Dentários S.A. · 2024
- Descendant · cites it directly · 0 of its ownK223662 Neodent Implant System - Helix Short Surgical Kit CasesJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2023
- Descendant · cites it directly · 0 of its ownK214051 Neodent Implant System-Helix NGM Compact Surgical Kit CasesJJGC Indústria e Comércio de Materiais Dentários S.A. · 2022
- Descendant · cites it directly · 0 of its ownK202515 NUVO Implant System – NUVO Instrument Kit CasesJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2020
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 backK023658 Sterilization Cases and TraysCarr Metal Products, Inc. · 2003
- 5 generations backK052992 Conmed Linvatec Instrument Sterilization TrayConmed Linvatec · 2006
- 4 generations backK142519 InterActive Complete Surgical TrayImplant Direct Sybron Manufacturing, LLC · 2015
- 3 generations backK160730 Instrument kitsAnthogyr · 2017
- 2 generations backK171713 Neodent Instrument KitsJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2018
- 1 generation backK182865 Neodent Instruments KitsJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2019
- This deviceK192670 Neodent Instrument Kit CasesJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2019
Most influential descendants
Showing 5 of 5 · See all- K203618Neodent EasyGuide Kit CasesJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2021 · cites it directly1descendant
- K241492Guided Surgery Kit CasesJJGC Indústria e Comércio de Materiais Dentários S.A. · 2024 · 2 generations on0descendants
- K223662Neodent Implant System - Helix Short Surgical Kit CasesJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2023 · cites it directly0descendants
- K214051Neodent Implant System-Helix NGM Compact Surgical Kit CasesJJGC Indústria e Comércio de Materiais Dentários S.A. · 2022 · cites it directly0descendants
- K202515NUVO Implant System – NUVO Instrument Kit CasesJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2020 · cites it directly0descendants
View 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 | K023658 | Sterilization Cases and Trays | Carr Metal Products, Inc. | 2003 | — |
| −5 | K052992 | Conmed Linvatec Instrument Sterilization Tray | Conmed Linvatec | 2006 | — |
| −4 | K142519 | InterActive Complete Surgical Tray | Implant Direct Sybron Manufacturing, LLC | 2015 | — |
| −3 | K160730 | Instrument kits | Anthogyr | 2017 | — |
| −2 | K171713 | Neodent Instrument Kits | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2018 | — |
| −1 | K182865 | Neodent Instruments Kits | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2019 | — |
| 0 (this device) | 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 | — |
| +2 | K241492 | Guided Surgery Kit Cases | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2024 | — |
| +1 | K223662 | Neodent Implant System - Helix Short Surgical Kit Cases | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2023 | — |
| +1 | K214051 | Neodent Implant System-Helix NGM Compact Surgical Kit Cases | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2022 | — |
| +1 | K202515 | NUVO Implant System – NUVO Instrument Kit Cases | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K182865 | Neodent Instruments KitsSummary page 5…General Hospital Reviewing Branch Infection Control Devices Branch PREDICATE DEVICE INFORMATION Primary Predicate Device K182865 – Neodent Instrument Kit Cases, JJGC Indústria e Comércio de Materiais Dentários SA JJ… | 2019 |
What descends from it? (5)
4 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 35 years and passes through 9 companies; a new generation was cleared every 2.0 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K203618 (Jjgc Industria E Comercio DE Materiais Dentarios S.A., 2021) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K182865.
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. 2019, 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?
Indications for Use for GM Surgical Kit Case: Neodent Instrument Kit Cases are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instrument Kit Cases are intended to allow sterilization of the enclosed medical devices. Neodent Instrument 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…
Read the full statement (340 words)
Indications for Use for GM Surgical Kit Case:
Neodent Instrument Kit Cases are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instrument Kit Cases are intended to allow sterilization of the enclosed medical devices. Neodent Instrument 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, 20-minute dry time.
Gravity displacement – Exposure at 132 °C for 15 minutes, 40-minute dry time.
Neodent Instrument Kit Cases are intended for sterilization of non-porous loads.
The combined weight of the GM Surgical Kit Case and the associated instruments is 613.1 g. The weight of the empty Kit Case is 510 grams.
Neodent Instrument Kit Cases should not to be stacked during sterilization.
Indications for Use for GM Helix Compact Surgical Kit Case:
Neodent Instrument Kit Cases are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instrument Kit Cases are intended to allow sterilization of the enclosed medical devices. Neodent Instrument 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, 20-minute dry time
Gravity displacement – Exposure at 132 °C for 15 minutes, 20-minute dry time.
Neodent Instrument Kit Cases are intended for sterilization of non-porous loads.
The combined weight of the GM Helix Compact Surgical Kit Case and the associated instruments is 308.2 g. The weight of the empty Kit Case is 231 grams.
Neodent Instrument Kit Cases should not to be stacked during sterilization.
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/K192670 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192670: Neodent Instrument 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/K192670
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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