510(k) · Cleared
ClearedBiotech Dental Kits
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biotech Dental, Sas · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Nov 8, 2021 as substantially equivalent to K191566 (Avinent Implant System S.L.U., 2020) and 2 other predicates after a 129-day review. Its family tree reaches back 10 generations to 1984.
- Decided
- Nov 8, 2021
- Review
- 129 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K844002 (1984). 19 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK212068 Biotech Dental KitsBiotech Dental, Sas · 2021
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 deviceK212068 Biotech Dental KitsBiotech Dental, Sas · 2021
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) | K212068 | Biotech Dental Kits | Biotech Dental, Sas | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 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? (3)
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 |
|---|---|---|---|
| * | K191566 | Avinent Surgical TraySummary page 14…es (OHT4) Reviewing Division Division of Infection Control and Plastic Surgery Devices (DHT4B) PREDICATE DEVICE INFORMATION The primary predicate device is K191566 Avinent Surgical Tray, Avinent Implant Systems, S.L.U. The additional predicate devices are K182865, Neodent Instrument Kits, JJG… | 2020 |
| * | K182865 | Neodent Instruments KitsSummary page 14…HT4B) PREDICATE DEVICE INFORMATION The primary predicate device is K191566 Avinent Surgical Tray, Avinent Implant Systems, S.L.U. The additional predicate devices are K182865, Neodent Instrument Kits, JJGC Indústria e Comércio de Materiais Dentários S.A., and K173391, OsteoMed MMF Sterilization Tray, Os… | 2019 |
| * | K173391 | OsteoMed QuickFix Hybrid MMF Sterilization TraySummary page 14…l Tray, Avinent Implant Systems, S.L.U. The additional predicate devices are K182865, Neodent Instrument Kits, JJGC Indústria e Comércio de Materiais Dentários S.A., and K173391, OsteoMed MMF Sterilization Tray, OsteoMed, LLC. 510(k) Summary… | 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 37 years and passes through 10 companies; a new generation was cleared every 2.5 years on median.
- None of the 19 ancestors has a recall.
- 1 other device also cites its predicate K191566.
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?
Drill Stop Kit is intended to be used to enclose drill stops that are to be sterilized by a health care provider. Drill Stop Kit is intended to allow sterilization of the enclosed medical devices. Drill Stop Kit requires the use of a double pouch to maintain the sterility of the enclosed devices (pouch must be FDA cleared in the U.S.) Drill Stop Kit is to be enclosed in a sterilization double pouch that is FDA cleared for the indicated cycles, and moist…
Read the full statement (1,827 words)
Drill Stop Kit is intended to be used to enclose drill stops that are to be sterilized by a health care provider. Drill Stop Kit is intended to allow sterilization of the enclosed medical devices. Drill Stop Kit requires the use of a double pouch to maintain the sterility of the enclosed devices (pouch must be FDA cleared in the U.S.)
Drill Stop Kit is to be enclosed in a sterilization double pouch that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:
In the U.S. only, dynamic air removal (pre-vacuum)– Exposure at 132 °C for 4 minutes and 20 minutes dry time.
Drill Stop Kit is intended for sterilization of non-porous loads.
Drill Stop Kit is recommended not to be stacked during sterilization.
The combined weight of the Drill Stop Kit and the associated devices is 199.8 grams.
The weight of the empty Drill Stop Kit is 192.6 grams.
Prosthetic Kit is intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Prosthetic Kit is intended to allow sterilization of the enclosed medical devices.
Prosthetic Kit requires the use of a double pouch to maintain the sterility of the enclosed devices (pouch must be FDA cleared in the U.S.)
Prosthetic Kit is to be enclosed in a sterilization double pouch that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:
In the U.S. only, dynamic air removal (pre-vacuum) – Exposure at 132 °C for 4 minutes and 20 minutes dry time.
Prosthetic Kit is intended for sterilization of non-porous loads.
Prosthetic Kit is recommended not to be stacked during sterilization.
The combined weight of the Prosthetic Kit and the associated instruments is 178.8 grams.
The weight of the empty Prosthetic Kit is 141.8 grams
Healing Screws Kit is intended to be used to enclose healing screws that are to be sterilized by a health care provider. Healing Screws Kit is intended to allow sterilization of the enclosed medical devices. Healing Screws Kit requires the use of a double pouch to maintain the sterility of the enclosed devices (pouch must be FDA cleared in the U.S.).
Healing Screws Kit is to be enclosed in a sterilization double pouch that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:
In the U.S. only, dynamic air removal (pre-vacuum) - Exposure at 132 °C for 4 minutes and 20 minutes dry time.
Healing Screws Kit is intended for sterilization of non-porous loads.
Healing Screws Kit is recommended not to be stacked during sterilization.
The combined weight of the Healing Screws Kit and the associated instruments is 203.1 grams.
The weight of the empty kit Healing Screws Kit is 168.9 grams.
Kit for Healing Screws Kontat Perio Level is intended to be used to enclose healing screws that are to be sterilized by a health care provider. Kit for Healing Screws Kontat Perio Level is intended to allow sterilization of the enclosed medical devices. Healing Screws Kit, Perio Level requires the use of a double pouch to maintain the sterility of the enclosed devices (pouch must be FDA cleared in the U.S.).
Kit for Healing Screws Kontat Perio Level is to be enclosed in a sterilization double pouch that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:
In the U.S. only, dynamic air removal (pre-vacuum) – Exposure at 132 °C for 4 minutes and 20 minutes dry time.
Kit for Healing Screws Kontat Perio Level is intended for sterilization of non-porous loads.
Kit for Healing Screws Kontat Perio Level is recommended not to be stacked during sterilization.
The combined weight of the Kit for Healing Screws Kontat Perio Level and the associated instruments is 206.0 grams.
The weight of the empty Kit for Healing Screws Kontat Perio Level is 169.0 grams.
Scanbodies Kit is intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Scanbodies Kit is intended to allow sterilization of the enclosed medical devices.
Scanbodies Kit requires the use of a double pouch to maintain the sterility of the enclosed devices (pouch must be FDA cleared in the U.S.)
Scanbodies Kit is to be enclosed in a sterilization double pouch that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:
In the U.S. only, dynamic air removal (pre-vacuum) – Exposure at 132 °C for 4 minutes and 20 minutes dry time.
Scanbodies Kit is intended for sterilization of non-porous loads.
Scanbodies Kit is recommended not to be stacked during sterilization.
The combined weight of the Scanbodies Kit and the associated instruments is 259.7 grams.
The weight of the empty Scanbodies Kit is 233.9 grams.
Pick-up Impression Coping Cica Kit is intended to be used to enclose pick-up impression copings that are to be sterilized by a health care provider. Pick-up Impression Coping Cica Kit is intended to allow sterilization of the enclosed medical devices. Pick-up Impression Coping Cica Kit requires the use of a double pouch to maintain the sterility of the enclosed devices (pouch must be FDA cleared in the U.S.)
Pick-up Impression Coping Cica Kit is to be enclosed in a sterilization double pouch that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:
In the U.S. only, dynamic air removal (pre-vacuum) – Exposure at 132 °C for 4 minutes and 20 minutes dry time.
Pick-up Impression Coping Cica Kit is intended for sterilization of non-porous loads.
Pick-up Impression Coping Cica Kit is recommended not to be stacked during sterilization.
The combined weight of the Pick-up Impression Coping Cica Kit and the associated instruments is 338.0 grams.
The weight of the empty tray Pick-up Impression Coping Cica Kit is 291.4 grams.
Pop-up Impression Coping Cica Kit is intended to be used to enclose pop-up impression copings that are to be sterilized by a health care provider. Pop-up Impression Coping Cica Kit is intended to allow sterilization of the enclosed medical devices. Pop-up Impression Coping Cica Kit requires the use of a double pouch to maintain the sterility of the enclosed devices (pouch must be FDA cleared in the U.S.)
Pop-up Impression Coping Cica Kit is to be enclosed in a sterilization double pouch that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:
In the U.S. only, dynamic air removal (pre-vacuum) – Exposure at 132 °C for 4 minutes and 20 minutes dry time.
Pop-up Impression Coping Cica Kit is intended for sterilization of non-porous loads.
Pop-up Impression Coping Cica Kit is recommended not to be stacked during sterilization.
The combined weight of the Pop-up Impression Coping Cica Kit and the associated instruments is 317.1 grams.
The weight of the empty kit Pop-up Impression Coping Cica Kit is 270.9 grams.
Multi Kontact Surgical Kit is intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Multi Kontact Surgical is intended to allow sterilization of the enclosed medical devices. Multi Kontact Surgical requires the use of a double pouch to maintain the sterility of the enclosed devices (pouch must be FDA cleared in the U.S.)
Multi Kontact Surgical is to be enclosed in a sterilization double pouch that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:
In the U.S. only, dynamic air removal (pre-vacuum) – Exposure at 132 °C for 4 minutes and 20 minutes dry time.
Multi Kontact Surgical is intended for sterilization of non-porous loads.
Multi Kontact Surgical is recommended not to be stacked during sterilization.
The combined weight of the Multi Kontact Surgical and the associated instruments is 580.7 grams.
The weight of the empty Multi Kontact Surgical is 449.6 grams.
Try-in Abutment Kit is intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Try-in Abutment Kit is intended to allow sterilization of the enclosed medical devices. Try-in Abutment Kit requires the use of a double pouch to maintain the sterility of the enclosed devices (pouch must be FDA cleared in the U.S.).
Try-in Abutment Kit is to be enclosed in a sterilization double pouch that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:
In the U.S. only, dynamic air removal (pre-vacuum) – Exposure at 132 °C for 4 minutes and 20 minutes dry time.
Try-in Abutment Kit is intended for sterilization of non-porous loads.
Try-in Abutment Kit is recommended not to be stacked during sterilization.
The combined weight of the Try-in Abutment Kit and the associated devices is 469.5 grams.
The weight of the empty Try-in Abutment Kit is 463.8 grams
AtlaSurgery Guided Surgery Kit is intended to be used to enclose other medical devices that are to be sterilized by a health care provider. AtlaSurgery Guided Surgery Kit is intended to allow sterilization of the enclosed medical devices. AtlaSurgery Guided Surgery Kit requires the use of a double pouch to maintain the sterility of the enclosed devices (pouch must be FDA cleared in the U.S.).
AtlaSurgery Guided Surgery Kit is to be enclosed in a sterilization double pouch that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:
In the U.S. only, dynamic air removal (pre-vacuum) – Exposure at 132 °C for 4 minutes and 20 minutes dry time.
AtlaSurgery Guided Surgery Kit is intended for sterilization of non-porous loads.
AtlaSurgery Guided Surgery Kit is recommended not to be stacked during sterilization.
The combined weight of the AtlaSurgery Guided Surgery Kit and the associated instruments is 689.2 grams.
The weight of the empty AtlaSurgery Guided Surgery Kit is 476.0 grams.
Pilot Drills Kit for Guided Surgery is intended to be used to group other medical devices that are to be sterilized by a health care provider. Pilot Drills Kit for Guided Surgery is intended to allow sterilization of the group medical devices. Pilot Drills Kit for Guided Surgery requires the use of a double pouch to maintain the sterility of the enclosed devices (pouch must be FDA cleared in the U.S.).
Pilot Drills Kit for Guided Surgery is to be enclosed in a sterilization double pouch that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:
In the U.S. only, dynamic air removal (pre-vacuum) – Exposure at 132 °C for 4 minutes and 20 minutes dry time.
Pilot Drills Kit for Guided Surgery is intended for sterilization of non-porous loads.
Pilot Drills Kit for Guided Surgery is recommended not to be stacked during sterilization.
The combined weight of the Pilot Drills Kit for Guided Surgery and the associated instruments is 39.4 grams.
The weight of the empty Pilot Drills Kit for Guided Surgery is 36.8 grams.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212068 · printed Nov 5, 2026
Cite this page
510(k) Report. “K212068: Biotech Dental Kits.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K212068
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