(129 days)
Not Found
No
The device description and intended use focus solely on the physical characteristics and sterilization process of reusable rigid containers for medical devices. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is a reusable rigid container (tray) intended for organizing, protecting, and allowing sterilization of other medical devices. It does not provide any direct therapeutic benefit to a patient.
No
The device is described as a reusable rigid container (tray) intended to organize, protect, and allow sterilization of other medical devices. Its function is to facilitate the sterilization process, not to diagnose a condition or disease.
No
The device description clearly states that the subject devices are "reusable rigid containers, comprising a base (bottom), a removable inner trav (if applicable), and a lid (cover)." It also details the materials used (plastic and stainless steel) and their physical characteristics (perforated). This indicates a physical hardware device, not software.
Based on the provided text, the device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: An In Vitro Diagnostic device is a medical device used to perform tests on samples such as blood, urine, or tissues to detect diseases or other conditions. These tests are performed outside of the body (in vitro).
- Intended Use: The intended use of the described devices (Drill Stop Kit, Prosthetic Kit, etc.) is consistently stated as being used to enclose other medical devices for sterilization by a healthcare provider. Their function is to facilitate the sterilization process and maintain the sterility of the enclosed items.
- Device Description: The device description details reusable rigid containers designed to organize and protect dental instruments and accessories during sterilization. It describes the materials and construction of the trays.
- Performance Studies: The performance studies focus on validating the cleaning, sterilization, drying, and life cycle of the trays themselves, as well as their biocompatibility. There are no studies related to analyzing biological samples or diagnosing conditions.
The devices described are sterilization trays/kits intended for use in preparing other medical devices for surgical procedures. They do not perform any diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
Drill Stop Kit is intended to be used to enclose drill stops that are to be sterlized 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 sterlization 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 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 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 200.0 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-vacum) – 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 Kit is intended to allow sterilization of the enclosed medical devices. Multi Kontact Surgical 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.). Multi Kontact Surgical 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. Multi Kontact Surgical Kit is intended for sterilization of non-porous loads. Multi Kontact Surgical Kit is recommended not to be stacked during sterilization. The combined weight of the Multi Kontact Surgical Kit and the associated instruments is 580.7 grams. The weight of the empty Multi Kontact Surgical Kit 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 sterlity 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 dry time. Trv-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. AtlaSurqery 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 sterlization 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 dry time. Pilot Drills Kit for Guided Surgery is intended for sterilization of non-porous loads. Pilot Drills Kit for Guided Surgerv 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.
Product codes (comma separated list FDA assigned to the subject device)
KCT
Device Description
The subject device trays are reusable rigid containers, comprising a base (bottom), a removable inner trav (if applicable), and a lid (cover). The subject device trays are to be used to organize and protect the dental healing screws, try-in abutments, instruments, and accessories that are sterilized in the trays by the healthcare provider. The base, inner tray, and lid components are designed to be integrated into a single unit which contains and protects the interior contents during sterilization. The trays are perforated to allow for penetration of the sterilant, are to be used with moist heat (steam), and require the use of an FDA cleared pouch to maintain sterility. The subject device includes a total of 10 sizes (same lid and base and enclosed volumes), and a total of 11 tray configurations. The subject device has seven (7) trays that are 2-piece plastic trays manufactured from Polyphenylsulfone (Radel® R-5000) for the lid and Polypropylene (PPHS) or Polysulfone for the base. The subject device has three (3) trays that are 3-piece plastic trays manufactured from Polyphenylsulfone (Radel R-5000) with silicone grommets. The subject device has one (1) tray that is a 2-piece metal tray manufactured from stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care provider
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Automated Cleaning Validation:
Methodology: FDA Guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (issued March 2015)
Purpose: To validate that the cleaning instructions provided in the Instructions for Use appropriately clean the tray, and to ensure the sterilization cycle will be effective.
Acceptance Criteria & Results:
Protein assay - Micro BCA Protein Assay: Acceptance criterion: less than 6.4 µg/cm², Assay quantitation limits: 5.0 µg/mL. Result: Pass.
TOC assay: Acceptance criterion: less than 2.010 mg/L, Assay quantitation limits: 2.010 mg/L. Result: Pass.
Sterilization Validation (including sterilant penetration and dry time validation):
Methodology: ANSI/AAMI/ISO 17665-1, ANSI/AAMI/ISO 17665-2
Purpose: To validate that the sterilization instructions listed in the Instructions for Use appropriately sterilize the tray and contents.
Acceptance Criteria & Results: 3 consecutive half-cycles performed for each of the two sizes of trays will demonstrate complete inactivation of all biologic indicators. A minimum SAL of 10^-6 is achieved if the Instructions for Use are followed. Result: Pass.
Dry time:
Purpose: To validate that the sterilization instructions listed in the Instructions for Use appropriately dry the pouched tray for storage.
Acceptance Criteria & Results: Using pre-cycle and post-cycle weights, the weight gain after drying will not exceed ± 3%. Result: Pass.
Life Cycle / Simulated Use Life Validation:
Methodology: FDA Guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (issued March 2015)
Purpose: To validate the service life of the trays as stated in the Instructions for Use.
Acceptance Criteria & Results: Visual inspection, component dimensional fit verification, functional closure/latch verification for 100 use cycles. Result: Pass.
Biocompatibility of Subject Device (by cytotoxicity testing):
Methodology: ANSI/AAMI/ISO 10993-5, ANSI/AAMI/ISO 10993-12
Purpose: To evaluate the cytotoxicity potential of the test article using an in vitro cell culture assay.
Acceptance Criteria & Results: Non-cytotoxic if ≤ 30% reduction of NRU cell viability after exposure to extract of the device. Result: Pass.
No clinical data were included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 8, 2021
Biotech Dental, SAS % Melissa Burbage RA Sr Specialist PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K212068
Trade/Device Name: Biotech Dental Kits Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: October 7, 2021 Received: October 8, 2021
Dear Melissa Burbage:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801: medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known)
Device Name
Biotech Dental Drill Stop Kit
Indications for Use (Describe)
Drill Stop Kit is intended to be used to enclose drill stops that are to be sterlized 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 intended for sterilization of non-porous loads.
Drill Stop Kit is recommended not to be stacked during sterilization.
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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
3
510(k) Number (if known)
Device Name
Biotech Dental Prosthetic Kit
Indications for Use (Describe)
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 sterlization 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
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW! *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
4
510(k) Number (if known)
Device Name
Biotech Dental Healing Screws Kit
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
5
510(k) Number (if known)
Device Name
Biotech Dental Kit for Healing Screws Kontact Perio Level
Indications for Use (Describe)
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 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 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 200.0 grams. The weight of the empty Kit for Healing Screws Kontat Perio Level is 169.0 grams.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
6
510(k) Number (if known)
Device Name
Biotech Dental Scanbodies Kit
Indications for Use (Describe)
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-vacum) – 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
7
510(k) Number (if known)
Device Name
Biotech Dental Pick-up Impression Coping Cica Kit
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
8
510(k) Number (if known)
Device Name
Biotech Dental Pop-up Impression Coping Cica Kit
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
9
510(k) Number (if known)
Device Name
Biotech Dental Multi Kontact Surgical Kit
Indications for Use (Describe)
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 sterlization 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 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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW! *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
10
510(k) Number (if known)
Device Name
Biotech Dental Try-in Abutment Kit
Indications for Use (Describe)
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 sterlity 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 dry time.
Trv-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
Type of Use (Select one or both, as applicable)
× Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
11
510(k) Number (if known)
Device Name
Biotech Dental AtlaSurgery Guided Surgery Kit
Indications for Use (Describe)
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.
AtlaSurqery 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
12
510(k) Number (if known)
Device Name
Biotech Dental Pilot Drills Kit for Guided Surgery
Indications for Use (Describe)
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 sterlization 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 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 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
13
510(k) Summary
Biotech Dental Kits
Biotech Dental, SAS
October 29, 2021
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Biotech Dental, SAS |
|---|---|
| 305, Allées de Craponne | |
| 13300 Salon de Provence | |
| France | |
| Telephone: | +33 4 90 44 60 60 |
| Fax: | +33 4 90 44 60 61 |
| Official Contact | Delphine Mercier, Vice President, Compliance |
| Representative/Consultant | Melissa Burbage, Senior Regulatory Specialist |
| Kevin A. Thomas, PhD | |
| Floyd G. Larson, MS, MBA | |
| PaxMed International, LLC | |
| 12264 El Camino Real, Suite 400 | |
| San Diego, CA 92130 | |
| Telephone: +1 858-792-1235 | |
| Fax: +1 858-792-1236 | |
| Email: mburbage@paxmed.com | |
| kthomas@paxmed.com, flarson@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | Biotech Dental Kits |
|---|---|
| Common Name | Instrument sterilization trays |
| Regulation Number | 21 CFR 880.6850 |
| Regulation Name | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Regulatory Class | Class II |
| Product Code | KCT |
| Classification Panel | General Hospital |
| Reviewing Office | Office of Surgical and Infection Control Devices (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, JJGC Indústria e Comércio de Materiais Dentários S.A., and K173391, OsteoMed MMF Sterilization Tray, OsteoMed, LLC.
14
INDICATIONS FOR USE STATEMENT
Indications for Use for Drill Stop Kit
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.
Indications for Use for Prosthetic Kit
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
Indications for Use for Healing Screws Kit
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.
Indications for Use for Kit for Healing Screws Kontact Perio Level
Kit for Healing Screws Kontact 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 Kontact Perio Level is intended to allow sterilization of the enclosed medical devices. Kit for Healing Screws Kontact 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 Kontact 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 Kontact Perio Level is intended for sterilization of non-porous loads.
Kit for Healing Screws Kontact Perio Level is recommended not to be stacked during sterilization.
The combined weight of the Kit for Healing Screws Kontact Perio Level and the associated instruments is 206.0 grams.
The weight of the empty Kit for Healing Screws Kontact Perio Level is 169.0 grams.
15
510(k) Summary Page 3 of 8
Indications for Use for Scanbodies Kit
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.
Indications for Use for Pick-up Impression Coping Cica Kit
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.
Indications for Use for Pop-up Impression Coping Cica Kit
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.
Indications for Use for Multi Kontact Surgery Kit
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 Kit is intended to allow sterilization of the enclosed medical devices. Multi Kontact Surgical 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.).
Multi Kontact Surgical 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. Multi Kontact Surgical Kit is intended for sterilization of non-porous loads.
Multi Kontact Surgical Kit is recommended not to be stacked during sterilization.
The combined weight of the Multi Kontact Surgical Kit and the associated instruments is 580.7 grams.
The weight of the empty Multi Kontact Surgical Kit is 449.6 grams.
16
510(k) Summary Page 4 of 8
Indications for Use for Try-in Abutment Kit
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.
Indications for Use for AtlaSurgery Guided Surgery Kit
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.
Indications for Use for Pilot Drills Kit for Guided Surgery
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 Surgerv 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.
SUBJECT DEVICE DESCRIPTION
The subject device trays are reusable rigid containers, comprising a base (bottom), a removable inner trav (if applicable), and a lid (cover). The subject device trays are to be used to organize and protect the dental healing screws, try-in abutments, instruments, and accessories that are sterilized in the trays by the healthcare provider. The base, inner tray, and lid components are designed to be integrated into a single unit which contains and protects the interior contents during sterilization. The trays are perforated to allow for penetration of the sterilant, are to be used with moist heat (steam), and require the use of an FDA cleared pouch to maintain sterility.
The subject device includes a total of 10 sizes (same lid and base and enclosed volumes), and a total of 11 tray configurations. The subject device has seven (7) trays that are 2-piece plastic trays manufactured
17
from Polyphenylsulfone (Radel® R-5000) for the lid and Polypropylene (PPHS) or Polysulfone for the base. The subject device has three (3) trays that are 3-piece plastic trays manufactured from Polyphenylsulfone (Radel R-5000) with silicone grommets. The subject device has one (1) tray that is a 2-piece metal tray manufactured from stainless steel.
TECHNOLOIGCAL CHARACTERISTIC COMPARSION TO MARKETED DEVICES
The subject device and the predicate devices have intended use, the same product classification and product code (KCT) and have similar Indications for Use statements. The subject device and the predicate devices are reusable rigid containers used to organize and protect the instruments that are sterilized by the healthcare provider. The subject device and the predicate devices are to be sterilized by moist heat (steam) and require the use of an FDA cleared pouch to maintain sterility.
Differences between the IFUS for the subject device and the predicate devices include structure of language, the names of the kits, and the weights of the individual kits (loaded and empty). The slight differences in language of the IFUS do not affect the intended use.
The subject device is provided in 10 sizes and 11 configurations; the primary predicate device K191566 is provided in one (1) size and one (1) configuration, the additional predicate device K182865 is provided in four (4) sizes and four (4) configurations, and the additional predicate device K173391 is provided in one (1) size and one (1) configuration. The subject device and the predicate devices have similar overall dimensions, enclose similar volumes, and have similar vent to volume ratios. Differences in the dimensions and vent to volume ratios between the subject device and the predicate devices are mitigated by the sterilization validation performed.
The subject device has seven (7) trays that are 2-piece plastic trays similar to the additional predicate
device K182865 in that both include components manufactured from polyphenylsulfone (Radel R-5000) for the lid and polypropylene (PPHS) or polysulfone for the base. Both materials have a history of biocompatibility and clinical use for the intended or cleared indications.
The subject device has three (3) trays that are 3-piece plastic trays similar to the primary predicate device K191566 in that both include components manufactured from polyphenvlsulfone (Radel R-5000) with silicone grommets. Both materials have a history of biocompatibility and clinical use for the intended or cleared indications.
The subject device has one (1) tray that is a 2-piece metal tray similar to the additional predicate device K173391 in that both include components manufactured from metal (stainless steel or aluminum). This material also has a history of biocompatibility and clinical use for the intended or cleared indications.
The subject device and the predicate devices are to be used according to similar labeling, including the use of an FDA cleared pouch and similar sterilization processes and cycles.
18
SUMMARY OF NON-CLINICAL TESTING
Provided below is a summary of the non-clinical performance testing included in this submission, including the test methods, purpose, acceptance criteria, and results.
| Test Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Automated Cleaning Validation | |||
| FDA Guidance Reprocessing | |||
| Medical Devices in Health Care | |||
| Settings: Validation Methods | |||
| and Labeling | |||
| (issued March 2015) | The purpose of this test is to | ||
| validate that the cleaning | |||
| instructions provided in the | |||
| Instructions for Use | |||
| appropriately clean the tray, | |||
| and to ensure the | |||
| sterilization cycle will be | |||
| effective. | Protein assay - Micro BCA Protein Assay | ||
| Acceptance criterion: less than 6.4 µg/cm² | |||
| Assay quantitation limits: 5.0 µg/mL | Pass | ||
| and Labeling | |||
| (issued March 2015) | appropriately clean the tray, | ||
| and to ensure the | |||
| sterilization cycle will be | |||
| effective. | TOC assay | ||
| Acceptance criterion: less than 2.010 mg/L | |||
| Assay quantitation limits: 2.010 mg/L | Pass | ||
| Sterilization Validation | |||
| including sterilant penetration | |||
| and dry time validation | |||
| ANSI/AAMI/ISO 17665-1 | |||
| ANSI/AAMI/ISO 17665-2 | The purpose of this test is to | ||
| validate that the sterilization | |||
| instructions listed in the | |||
| Instructions for Use | |||
| appropriately sterilize the | |||
| tray and contents. | Acceptance criterion: | ||
| 3 consecutive half-cycles performed for | |||
| each of the two sizes of trays will | |||
| demonstrate complete inactivation of all | |||
| biologic indicators; | |||
| A minimum SAL of $10^{-6}$ is achieved if the | |||
| Instructions for Use are followed | Pass | ||
| Dry time | The purpose of this test is to | ||
| validate that the sterilization | |||
| instructions listed in the | |||
| Instructions for Use | |||
| appropriately dry the | |||
| pouched tray for storage. | Acceptance criterion: | ||
| Using pre-cycle and post-cycle weights, | |||
| the weight gain after drying will not | |||
| exceed ± 3% | Pass | ||
| Life Cycle / Simulated Use Life | |||
| Validation | |||
| FDA Guidance Reprocessing | |||
| Medical Devices in Health Care | |||
| Settings: Validation Methods | |||
| and Labeling | |||
| (issued March 2015) | The purpose of this test is to | ||
| validate the service life of | |||
| the trays as stated in the | |||
| Instructions for Use. | Acceptance criteria: | ||
| Visual inspection, component dimensional | |||
| fit verification, functional closure/latch | |||
| verification for 100 use cycles | Pass | ||
| Biocompatibility of Subject | |||
| Device (by cytotoxicity testing) | |||
| ANSI/AAMI/ISO 10993-5 | |||
| ANSI/AAMI/ISO 10993-12 | The purpose of this test is to | ||
| evaluate the cytotoxicity | |||
| potential of the test article | |||
| using an in vitro cell culture | |||
| assay. | Acceptance criterion: | ||
| Non-cytotoxic if ≤ 30% reduction of NRU | |||
| cell viability after exposure to extract of | |||
| the device | Pass |
Summary of Nonclinical Testing
In summary, the nonclinical testing provided for these devices met the acceptance criteria for each standard and test methodology used to evaluate the devices as shown in the table above
No clinical data were included in this submission.
CONCLUSION
The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate devices.
19
Table of Technological
| Feature | Subject Device | Primary Predicate Device | Additional Predicate Device | Additional Predicate Device | Comparison | ||||
|---|---|---|---|---|---|---|---|---|---|
| Biotech Dental Kits | |||||||||
| Biotech Dental SAS | K191566 | ||||||||
| Avinent Surgical Tray | |||||||||
| Avinent Implant Systems, S.L.U. | K182865 | ||||||||
| Neodent Instrument Kits | |||||||||
| JJGC Indústria e Comércio de Materiais | |||||||||
| Dentários S.A. | K173391 | ||||||||
| OsteoMed MMF Sterilization Tray | |||||||||
| OsteoMed LLC | |||||||||
| Product Model | |||||||||
| Numbers | Full: KBK, KPK, KVCK, KPLVCK, KSCANK, | ||||||||
| KTIPK, KTOPK, TROUSSEKONTMULTI, | |||||||||
| KPJFKIT, KATLAK, KSFE20KIT | |||||||||
| Empty: KBKV, KPKV, KVCKV, KPLVCKV, | |||||||||
| KSCANKV, KTIPKV, KTOPKV, 6000, | |||||||||
| KPJFKITV, KATLAKV, KSFE20KITV | Not listed in summary | 100.287, 110.294, 110.295, 110.296, | Not listed in summary | ||||||
| Product Code | KCT | KCT | KCT | KCT | Same | ||||
| Intended Use | organize and protect the devices, instruments, and | ||||||||
| accessories that are sterilized by health care | |||||||||
| provider | organize and protect the devices, instruments, and | ||||||||
| accessories that are sterilized by health care | |||||||||
| provider | organize and protect the devices, instruments, and | ||||||||
| accessories that are sterilized by health care | |||||||||
| provider | organize and protect the devices, instruments, and | ||||||||
| accessories that are sterilized by health care | |||||||||
| provider | Same | ||||||||
| Design | 2-piece plastic trays | ||||||||
| Rigid polymer base and lid | |||||||||
| 3-piece plastic trays | |||||||||
| Rigid polymer base, lid, and removable | |||||||||
| inner tray | |||||||||
| 2-piece metal trays | |||||||||
| Rigid metal base, lid, and inner tray. | Rigid polymer base, lid, and removable inner tray | Rigid polymer base, lid, and removable inner tray | Rigid metal base, lid, and removable inner tray | 2-piece plastic trays | |||||
| Similar to K191566 | |||||||||
| 3-piece plastic trays | |||||||||
| Similar to K182865 | |||||||||
| 2-piece metal trays | |||||||||
| Similar to K173391 | |||||||||
| Materials | 2-piece plastic trays | ||||||||
| Polyphenylsulfone (PPSU) (Radel | |||||||||
| R5000) [lid] | |||||||||
| Polypropylene (PPHS) [base] | |||||||||
| 3-piece plastic trays | |||||||||
| Polyphenylsulfone (PPSU) (Radel | |||||||||
| R5000) [lid, base, insert] | |||||||||
| Medical grade silicone [grommets] | |||||||||
| 2-piece metal trays | |||||||||
| Stainless Steel AISI 304L | |||||||||
| Medical grade silicone [grommets] | Polyphenylsulfone (Radel R-5000) [lid, base, tray] | ||||||||
| Medical grade silicone [grommets/holders] | Polysulfone [base, tray] | ||||||||
| Polyphenylsulfone (Radel R5000) [lid] | |||||||||
| Medical grade silicone [grommets] | |||||||||
| Titanium alloy [retention fixtures] | Aluminum [metal lid and base] | 2-piece plastic trays | |||||||
| Similar to K191566 | |||||||||
| 3-piece plastic trays | |||||||||
| Similar to K182865 | |||||||||
| 2-piece metal trays | |||||||||
| Similar to K173391 | |||||||||
| Materials | |||||||||
| Compatible with | |||||||||
| Sterilization | |||||||||
| Method | Yes | Yes | Yes | Yes | Same | ||||
| Perforated | Yes; allows moist heat (steam) penetration to | ||||||||
| achieve sterilization | Yes; allows moist heat (steam) penetration to | ||||||||
| achieve sterilization | Yes; allows moist heat (steam) penetration to | ||||||||
| achieve sterilization | Yes; allows moist heat (steam) penetration to | ||||||||
| achieve sterilization | Same | ||||||||
| Number of Overall | |||||||||
| Sizes | 10 | 1 | 4 | 1 | Similar | ||||
| Number of | |||||||||
| Configurations | 11 | 2 | 4 | 1 | Similar | ||||
| Overall | |||||||||
| Dimensions | Length x Width x Height | Vent to Volume | |||||||
| Ratio | Length x Width x Height | Vent to Volume | |||||||
| Ratio | Length x Width x Height | Vent to Volume | |||||||
| Ratio | Length x Width x Height | Vent to Volume | |||||||
| Ratio | Similar to K191566 | ||||||||
| and | |||||||||
| Vent to Volume | |||||||||
| Ratio | 150 mm x 65 mm x 25 mm | $0.2259 cm^2/cm^3$ | 207.5 mm x 157.5 mm x 71.7 | ||||||
| mm | $0.0043 cm^2 / cm^3$ | ||||||||
| (0.011 in $^2$ / in $^3$ ) | 264 mm x 163 mm x 54 mm | $0.0102 cm^2 / cm^3$ | 241.3 mm x 127 mm x 38.1 | ||||||
| mm | $0.0197 cm^2 / cm^3$ | ||||||||
| (0.050 in $^2$ / in $^3$ ) | |||||||||
| 150 mm x 65 mm x 25 mm | $0.1472 cm^2/cm^3$ | 195 mm x 90 mm x 54 mm | $0.0191 cm^2 / cm^3$ | ||||||
| 150 mm x 65 mm x 25 mm | $0.3694 cm^2/cm^3$ | 195 mm x 90 mm x 44 mm | $0.0247 cm^2 / cm^3$ | ||||||
| 150 mm x 65 mm x 25 mm | $0.3932 cm²/cm³$ | 264 mm x 90 mm x 58 mm | $0.0093 cm²/cm³$ | ||||||
| 125 mm x 127 mm x 24.5 mm | $0.1224 cm²/cm³$ | ||||||||
| 125 mm x 127 mm x 36.5 mm | $0.0346 cm²/cm³$ | ||||||||
| 125 mm x 127 mm x 32.5 mm | $0.0567 cm²/cm³$ | ||||||||
| 162.2 mm x 170 mm x 55 mm | $0.0049 cm²/cm³$ | ||||||||
| 162.2 mm x 170 mm x 55 mm | $0.0049 cm²/cm³$ | ||||||||
| 162.2 mm x 170 mm x 65 mm | $0.0041 cm²/cm³$ | ||||||||
| 40 mm x 50 mm x 20 mm | $0.9500 cm²/cm³$ | ||||||||
| Reusable | Yes | Yes | Yes | Yes | Same | ||||
| Use Life Testing | Reusable up to 100 cycles | ||||||||
| Assembled, sterilized | |||||||||
| Visual inspection | |||||||||
| Component dimensional fit verification | |||||||||
| Functional closure (lid-base latch) verification | Reusable up to 100 cycles | ||||||||
| Assembled, sterilized | |||||||||
| Visual inspection | Reusable up to 100 cycles | ||||||||
| Assembled/disassembled, cleaned, sterilized | |||||||||
| Visual inspection | |||||||||
| Component dimensional fit verification | |||||||||
| Functional closure (lid-base latch) verification | Not listed in 510(k) Summary | Similar | |||||||
| Sterilization Method | |||||||||
| Sterilant | Moist heat (steam) | Moist heat (steam) | Moist heat (steam) | Same | |||||
| Cycles | Fractionated vacuum (pre-vacuum) | ||||||||
| Exposure at 132 oC (270 oF) for 4 minutes with 20 | |||||||||
| minutes drying time. | Fractionated vacuum (pre-vacuum) | ||||||||
| Exposure at 132 oC (270 oF) for 4 minutes with 30 | |||||||||
| minutes drying time. | Gravity displacement and fractionated vacuum | ||||||||
| (pre-vacuum) | |||||||||
| Fractionated vacuum (pre-vacuum) - Exposure at | |||||||||
| 132 oC for 4 minutes, 20 minute dry time | |||||||||
| Gravity displacement – Exposure at 132 oC for 15 | |||||||||
| minutes, 20 minute dry time | Fractionated vacuum (pre-vacuum) | ||||||||
| Exposure at 132 oC (270 oF) for 4 minutes with 30 | |||||||||
| minutes drying time. | Same | ||||||||
| Sterile Barrier | Sterilization pouch, FDA cleared for indicated | ||||||||
| method and cycle | Sterilization wrap, FDA cleared for indicated | ||||||||
| method and cycle | Sterilization wrap, FDA cleared for indicated | ||||||||
| method and cycles | Sterilization wrap, FDA cleared for indicated | ||||||||
| method and cycle | Same |
20