Neodent Instrument Kit Cases

K192670 · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · KCT · Dec 18, 2019 · General Hospital

Device Facts

• Record ID: K192670
• Device Name: Neodent Instrument Kit Cases
• Applicant: Jjgc Industria E Comercio DE Materiais Dentarios S.A.
• Product Code: KCT · General Hospital
• Decision Date: Dec 18, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

Neodent Instrument Kit Cases are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instrument Kit Cases are intended to allow sterilization of the enclosed medical devices. Neodent Instrument Kit Cases require the use of FDA cleared wrap to maintain the sterility of the enclosed devices.

Device Story

Neodent Instrument Kit Cases are reusable, rigid containers designed to organize and protect dental surgical instruments during sterilization. The system consists of a polysulfone base, a removable inner tray, and a polyphenylsulfone lid, featuring silicone grommets to retain instruments. The device is used in clinical settings by healthcare providers. The cases are perforated to allow steam penetration during moist heat sterilization cycles (fractionated vacuum or gravity displacement). After loading, the case is enclosed in an FDA-cleared sterilization wrap. The device is intended for non-porous loads and is validated for up to 100 reprocessing cycles, including cleaning and steam sterilization. By providing a structured, protective environment, the kit cases facilitate the organized sterilization and storage of surgical instruments, ensuring they remain sterile until use.

Clinical Evidence

No clinical data. Bench testing only. Validation included manual cleaning (hemoglobin/protein testing), sterilization efficacy (SAL 10^-6 per ANSI/AAMI/ISO 17665), 100-cycle life cycle simulation, and biocompatibility (cytotoxicity per ANSI/AAMI/ISO 10993-5). All tests passed.

Technological Characteristics

Materials: Polysulfone (base/tray), Polyphenylsulfone (lid), medical-grade silicone (grommets). Design: Perforated rigid container. Sterilization: Moist heat (steam), gravity displacement or fractionated vacuum. Connectivity: None. Software: None.

Indications for Use

Indicated for use by healthcare providers to enclose and sterilize non-porous medical devices via moist heat (steam) sterilization. Requires FDA-cleared sterilization wrap. Not for stacking during sterilization.

Regulatory Classification

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.

Predicate Devices

• Neodent Instrument Kit Cases (K182865)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & 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.

December 18, 2019

JJGC Industria e Comercio de Materiais Dentarios S.A. % Jennifer Jackson Director of Regulatory Affairs & Ouality Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810

Re: K192670

Trade/Device Name: Neodent Instrument Kit Cases Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: September 23, 2019 Received: September 25, 2019

Dear Jennifer Jackson:

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 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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Sreekanth Gutala, PhD Acting 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}------------------------------------------------

# Indications for Use

510(k) Number (if known)

#### K192670

Device Name Neodent Instrument Kit Cases

Indications for Use (Describe)

Indications for Use for GM Surgical Kit Case:

Neodent Instrument Kit Cases are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instrument Kit Cases are intended to allow sterilization of the enclosed medical devices. Neodent Instrument Kit Cases require the use of FDA cleared wrap to maintain the sterility of the enclosed devices.

The kits are to be enclosed in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist heat (steam) sterilized using one of the following cycles:

Fractionated vacuum (pre-vacuum) - Exposure at 132 °C for 4 minutes, 20-minute dry time.

Gravity displacement - Exposure at 132 °C for 15 minutes, 40-minute dry time.

Neodent Instrument Kit Cases are intended for sterilization of non-porous loads.

The combined weight of the GM Surgical Kit Case and the associated instruments is 613.1 g. The weight of the empty Kit Case is 510 grams.

Neodent Instrument Kit Cases should not to be stacked during sterilization.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: overline;">☐</span> 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

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# Indications for Use

510(k) Number (if known)

K192670

Device Name Neodent Instrument Kit Cases

#### Indications for Use (Describe)

Indications for Use for GM Helix Compact Surgical Kit Case:

Neodent Instrument Kit Cases are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instrument Kit Cases are intended to allow sterilization of the enclosed medical devices. Neodent Instrument Kit Cases require the use of FDA cleared wrap to maintain the sterility of the enclosed devices.

The kits are to be enclosed in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist heat (steam) sterilized using one of the following cycles:

Fractionated vacuum (pre-vacuum) - Exposure at 132 °C for 4 minutes, 20-minute dry time

Gravity displacement - Exposure at 132 °C for 15 minutes, 20-minute dry time.

Neodent Instrument Kit Cases are intended for sterilization of non-porous loads.

The combined weight of the GM Helix Compact Surgical Kit Case and the associated instruments is 308.2 g. The weight of the empty Kit Case is 231 grams.

Neodent Instrument Kit Cases should not to be stacked during sterilization.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

# 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

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

# 510(K) Summary K192670

# ADMINISTRATIVE INFORMATION

| Sponsor | JJGC Indústria e Comércio de Materiais Dentários SA<br>Av. Juscelino Kubitschek de Olivera, 3291<br>Curitiba, Parana, Brazil 81270-200<br>Registration No.: 3008261720<br>Owner/Operator No.: 10031702 |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Jennifer M. Jackson, MS<br>Director of Regulatory Affairs,<br>Straumann USA<br>E-Mail: [e-mail]<br>Telephone [phone] |
| Date Prepared | 16/Dec/2019 |
| Preparer / Alternate Contact | Luiza Vaccari Toppel<br>Regulatory Affairs Coordinator<br>JJGC Indústria e Comércio de Materiais Dentários SA<br>[e-mail] |
| DEVICE NAME AND CLASSIFICATION | |
| Trade/ Proprietary Name<br>Common Name | Neodent Instrument Kit Cases<br>Instrument Sterilization Trays |
| Classification Name<br>Accessories | Sterilization Wrap Containers, Trays, Cassettes & Other |
| Classification Regulations<br>Product Code | 21 CFR 880.6850, Class II<br>KCT |
| Classification Panel<br>Reviewing Branch | General Hospital<br>Infection Control Devices Branch |
| PREDICATE DEVICE INFORMATION | |
| Primary Predicate Device | K182865 - Neodent Instrument Kit Cases, JJGC Indústria<br>Comércio de Materiais Dentários SA |

{5}------------------------------------------------

## INDICATIONS FOR USE

## Indications for Use for GM Surgical Kit Case:

Neodent Instrument Kit Cases are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instrument Kit Cases are intended to allow sterilization of the enclosed medical devices. Neodent Instrument Kit Cases require the use of FDA cleared wrap to maintain the sterility of the enclosed devices.

The kits are to be enclosed in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist heat (steam) sterilized using one of the following cycles:

Fractionated vacuum (pre-vacuum) – Exposure at 132 °C for 4 minutes, 20-minute dry time.

Gravity displacement - Exposure at 132 °C for 15 minutes, 40-minute dry time.

Neodent Instrument Kit Cases are intended for sterilization of non-porous loads.

The combined weight of the GM Surgical Kit Case and the associated instruments is 613.1 g. The weight of the empty Kit Case is 510 grams.

Neodent Instrument Kit Cases should not to be stacked during sterilization.

# Indications for Use for GM Helix Compact Surgical Kit Case:

Neodent Instrument Kit Cases are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instrument Kit Cases are intended to allow sterilization of the enclosed medical devices. Neodent Instrument Kit Cases require the use of FDA cleared wrap to maintain the sterility of the enclosed devices.

The kits are to be enclosed in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist heat (steam) sterilized using one of the following cycles:

Fractionated vacuum (pre-vacuum) – Exposure at 132 °C for 4 minutes, 20-minute dry time

Gravity displacement - Exposure at 132 °C for 15 minutes, 20-minute dry time.

Neodent Instrument Kit Cases are intended for sterilization of non-porous loads.

The combined weight of the GM Helix Compact Surgical Kit Case and the associated instruments is 308.2 g. The weight of the empty Kit Case is 231 grams.

Neodent Instrument Kit Cases should not to be stacked during sterilization.

# SUBJECT DEVICE DESCRIPTION

The subject device kit cases are reusable rigid containers, comprising a case bottom (or base), a removable inner tray, and tray lid (lid). The subject device kits are to be used to organize and protect instruments and accessories that are to be sterilized by the healthcare provider. The subject devices include two (2) such kit cases. The lids are manufactured from injection molded polyphenylsulfone resin, the tray and base are manufactured from injection molded polysulfone resin. The designs include grommets and inserts of various geometries manufactured from molded silicone that retain the instruments within the tray and base. The subject device kit cases are provided nonsterile to the end-user.

{6}------------------------------------------------

The dimensions for each part of the model and the overall dimensions are presented in the table below:

| Assembled<br>Kit Case | Description | Assembled Kit<br>Case Dimension<br>(L x W x H) | Component Number | Component Dimension<br>(L x W x H) |
|-----------------------|---------------------------------------|------------------------------------------------|------------------|------------------------------------|
| 110.288 | GM Surgical Kit Case | 264 x 163 x 54,<br>mm | 212.294 (Lid) | 264 x 163 x 43 mm |
| | | | 212.311 (Tray) | 248 x 149 x 16 mm |
| | | | 212.318 (Base) | 256 x 155 x 22 mm |
| 110.297 | GM Helix Compact<br>Surgical Kit Case | 195 x 90 x 64,<br>mm | 212.293 (Lid) | 195 x 90 x 36 mm |
| | | | 212.330 (Tray) | 180 x 76 x 27 mm |
| | | | 212.331 (Base) | 188 x 84 x 42 mm |

Note: The instruments and accessory devices that are sterilized and stored within the subject Kit Cases are not the subject devices of this submission.

{7}------------------------------------------------

## TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLE

| | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | |
|---------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | K192670<br>Neodent Instrument Kit Cases<br>JJGC Indústria e Comércio de Materiais Dentários S.A. | K182865<br>Neodent Instrument Kits<br>JJGC Indústria e Comércio de Materiais Dentários S.A. | COMPARISON |
| Indications for<br>Use Statement | Indications for Use for GM Surgical Kit Case:<br>Neodent Instrument Kit Cases are intended to be used to enclose other<br>medical devices that are to be sterilized by a health care provider. Neodent<br>Instrument Kit Cases are intended to allow sterilization of the enclosed<br>medical devices. Neodent Instrument Kit Cases require the use of FDA<br>cleared wrap to maintain the sterility of the enclosed devices.<br>The kits are to be enclosed in a sterilization wrap that is FDA-cleared for the<br>indicated cycles, and moist heat (steam) sterilized using one of the following<br>cycles:<br>Fractionated vacuum (pre-vacuum) - Exposure at 132 °C for 4 minutes, 20-<br>minute dry time.<br>Gravity displacement – Exposure at 132 °C for 15 minutes, 40-minute dry<br>time.<br>Neodent Instrument Kit Cases are intended for sterilization of non-porous<br>loads.<br>The combined weight of the GM Surgical Kit Case and the associated<br>instruments is 613.1 g. The weight of the empty Kit Case is 510 grams.<br>Neodent Instrument Kit Cases should not to be stacked during sterilization.<br>Indications for Use for GM Helix Compact Surgical Kit Case:<br>Neodent Instrument Kit Cases are intended to be used to enclose other<br>medical devices that are to be sterilized by a health care provider. Neodent<br>Instrument Kit Cases are intended to allow sterilization of the enclosed<br>medical devices. Neodent Instrument Kit Cases require the use of FDA<br>cleared wrap to maintain the sterility of the enclosed devices.<br>The kits are to be enclosed in a sterilization wrap that is FDA-cleared for the<br>indicated cycles, and moist heat (steam) sterilized using one of the following<br>cycles:<br>Fractionated vacuum (pre-vacuum) - Exposure at 132 °C for 4 minutes, 20-<br>minute dry time<br>Gravity displacement - Exposure at 132 °C for 15 minutes, 20-minute dry<br>time.<br>Neodent Instrument Kit Cases are intended for sterilization of non-porous<br>loads.<br>The combined weight of the GM Helix Compact Surgical Kit Case and the<br>associated instruments is 308.2 g. The weight of the empty Kit Case is 231<br>grams.<br>Neodent Instrument Kit Cases should not to be stacked during sterilization. | Indications for Use for GM/WS Surgical Kit Case:<br>Neodent Instrument Kits are intended to be used to enclose other medical<br>devices that are to be sterilized by a health care provider. Neodent<br>Instrument Kits are intended to allow sterilization of the enclosed medical<br>devices. Neodent Instrument Kits require the use of FDA cleared wrap to<br>maintain the sterility of the enclosed devices.<br>The kits are to be enclosed in a sterilization wrap that is FDA-cleared for the<br>indicated cycles, and moist heat (steam) sterilized using one of the following<br>cycles:<br>Fractionated vacuum (pre-vacuum) — Exposure at 132 °C for 4 minutes, 20<br>minute dry time.<br>Gravity displacement – Exposure at 132 °C for 15 minutes, 20 minute dry<br>time<br>Neodent Instrument Kits are intended for sterilization of non-porous loads.<br>The combined weight of the GM/WS Surgical Kit Case and the associated<br>instruments is 674.5 g. The weight of the empty Kit Case is 507 grams.<br>Neodent Instrument Kits are recommended not to be stacked during<br>sterilization.<br>Indications for Use for GM Prosthetic Kit Case:<br>Neodent Instrument Kits are intended to be used to enclose other medical<br>devices that are to be sterilized by a health care provider. Neodent<br>Instrument Kits are intended to allow sterilization of the enclosed medical<br>devices. Neodent Instrument Kits require the use of FDA-cleared wrap to<br>maintain the sterility of the enclosed devices.<br>The kits are to be enclosed in a sterilization wrap that is FDA-cleared for the<br>indicated cycles, and moist heat (steam) sterilized using one of the following<br>cycles:<br>Fractionated vacuum (pre-vacuum) - Exposure at 132 °C for 4 minutes, 20-<br>minute dry time<br>Gravity displacement – Exposure at 132 °C for 15 minutes, 20-minute dry<br>time.<br>Neodent Instrument Kits are intended for sterilization of non-porous loads.<br>The combined weight of the GM Prosthetic Kit Case and the associated<br>instruments is 250.5 g. The weight of the empty Kit Case is 210 grams.<br>Neodent Instrument Kits are recommended not to be stacked during<br>sterilization.<br>Indications for Use for GM Try-In Kit Case: | Similar |
| | | Neodent Instrument Kits are intended to be used to enclose other medical | |
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | | |
| K192670<br>Neodent Instrument Kit Cases<br>JJGC Indústria e Comércio de Materiais Dentários S.A. | K182865<br>Neodent Instrument Kits<br>JJGC Indústria e Comércio de Materiais Dentários S.A. | COMPARISON | |
| | devices that are to be sterilized by a health care provider Neodent<br>Instrument Kits require the use of FDA-cleared wrap to maintain the sterility<br>of the enclosed devices. | | |
| | The kits are to be enclosed in a sterilizable wrap that is FDA-cleared for the<br>indicated cycles, and moist heat (steam) sterilized using one of the following<br>cycles: | | |
| | Fractionated vacuum (pre-vaccum) - Exposure at 132 °C for 4 minutes, 20-<br>minute dry time. | | |
| | Gravity displacement – Exposure at 132 ºC for 15 minutes, 20-minute dry<br>time. | | |
| | Neodent Instrument Kits are intended for sterilization of non-porous loads. | | |
| | The combined weight of the GM Try-In Kit Case and the associated<br>instruments is 212.6 g. The weight of the empty Kit Case is 195 grams. | | |
| | Neodent Instrument Kits are recommended not to be stacked during<br>sterilization. |…