# K212068: Biotech Dental Kits

- Pathway: 510(k) (Traditional)
- Applicant: Biotech Dental, Sas
- Decided: Nov 8, 2021 after 129 days
- Product code: KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K844002 (1984). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191566: Avinent Surgical Tray, Avinent Implant System S.L.U. (2020) Summary page 14.
- K182865: Neodent Instruments Kits, Jjgc Industria E Comercio DE Materiais Dentarios S.A. (2019) Summary page 14.
- K173391: OsteoMed QuickFix Hybrid MMF Sterilization Tray, Osteomed, LLC (2018) Summary page 14.

## Indications for use
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.

Source page: https://510kreport.com/device/K212068
Methodology: https://510kreport.com/methodology