Neodent Instruments Kits

K182865 · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · KCT · May 7, 2019 · General Hospital

Device Facts

• Record ID: K182865
• Device Name: Neodent Instruments Kits
• Applicant: Jjgc Industria E Comercio DE Materiais Dentarios S.A.
• Product Code: KCT · General Hospital
• Decision Date: May 7, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

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

Device Story

Neodent Instrument Kits are reusable rigid containers designed to organize and protect dental surgical instruments during steam sterilization. The kits consist of a polysulfone base, a removable inner tray, and a polyphenylsulfone lid, with silicone grommets and titanium alloy holders to secure instruments. The kits are provided non-sterile to healthcare providers. The provider places instruments into the kit, wraps the kit in an FDA-cleared sterilization wrap, and subjects it to validated gravity displacement or fractionated vacuum steam sterilization cycles. The perforated design allows sterilant penetration. After sterilization, the wrap maintains the sterility of the enclosed devices until use. The kits are reusable for up to 100 cycles, subject to visual inspection and functional verification of the closure mechanism.

Clinical Evidence

Bench testing only. Validation included manual cleaning, sterilization efficacy (sterilant penetration and drying time per ANSI/AAMI/ISO 17665-1/2), life cycle simulation (100 cycles), and biocompatibility (cytotoxicity per ISO 10993-5). All tests passed.

Technological Characteristics

Reusable rigid containers; materials: polysulfone (base/tray), polyphenylsulfone (lid), silicone (grommets), Ti-6Al-4V-ELI (holders). Perforated design for steam penetration. Sterilization: moist heat (steam) via gravity displacement or fractionated vacuum. Dimensions vary by model. No software or electronics.

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 use with stacked kits.

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 Kits (K171713)

Reference Devices

• Genesis™ Reusable Rigid Sterilization Container System (K142529)
• Sonicision Reusable Sterilization Tray (K180915)

Submission Summary (Full Text)

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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.

May 7, 2019

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

Re: K182865

Trade/Device Name: Neodent Instruments Kits Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: April 8, 2019 Received: April 9, 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.

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For David Krause, PhD Acting 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

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510(k) Number (if known)

K182865 Device Name Neodent Instrument Kits

Indications for Use (Describe)

Indications for Use for GM/WS Surgical Kit Case:

Neodent Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instrument Kits are intended to allow sterilization of the enclosed medical devices. Neodent Instrument Kits 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 Kits are intended for sterilization of non-porous loads.

The combined weight of the GM/WS Surgical Kit Case and the associated instruments is 674.5 g. The weight of the empty Kit Case is 507 grams.

Neodent Instrument Kits are recommended not to be stacked during sterilization.

| 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) |

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510(k) Number (if known)

K182865 Device Name Neodent Instrument Kits

Indications for Use (Describe)

Indications for Use for GM Prosthetic Kit Case:

Neodent Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instrument Kits are intended to allow sterilization of the enclosed medical devices. Neodent Instrument Kits 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 Kits are intended for sterilization of non-porous loads.

The combined weight of the GM Prosthetic Kit Case and the associated instruments is 250.5 g. The weight of the empty Kit Case is 210 grams.

Neodent Instrument Kits are recommended not to be stacked during sterilization.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: DejaVu Sans, sans-serif">☑</span> |
|----------------------------------------------|-------------------------------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <span>☐</span> |

## 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

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510(k) Number (if known)

K182865 Device Name Neodent Instrument Kits

Indications for Use (Describe)

Indications for Use for GM Try-In Kit Case:

Neodent Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider Neodent Instrument Kits require the use of FDA-cleared wrap to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilizable wrap that is FDA-cleared for the indicated cycles, and moist heat (steam) sterilized using one of the following cycles:

Fractionated vacuum (pre-vaccum) - 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 Kits are intended for sterilization of non-porous loads.

The combined weight of the GM Try-In Kit Case and the associated 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 sterilization.

Type of Use (Select one or both, as applicable)

| <span style="text-decoration: underline;">Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span> </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

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

510(k) Number (if known)

K182865 Device Name Neodent Instrument Kits

Indications for Use (Describe)

Indications for Use for GM Guided Surgery Kit Case:

Neodent Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instrument Kits are intended to allow sterilization of the enclosed medical devices. Neodent Instrument Kits 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 Kits are intended for sterilization of non-porous loads.

The combined weight of the GM Guided Surgery Surgical Kit Case and the associated instruments is 728.4 g. The weight of the empty Kit Case is 567 grams.

Neodent Instrument Kits are recommended 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

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## 510(k) Summary K182865

ADMINISTRATIVE INFORMATION

| Sponsor | JJGC Indústria e Comércio de Materiais Dentários SA<br>Av. Juscelino Kubitschek de Oliveira, 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 & Quality,<br>Straumann USA<br>E-Mail: [e-mail]<br>Telephone [phone] |
| Date Prepared | 30/Apr/2019 |
| Preparer / Alternate Contact | Mariana Soares Hartmann<br>Regulatory Affairs Analyst<br>E-Mail: [e-mail] |
| DEVICE NAME AND CLASSIFICATION | |
| Trade/ Proprietary Name<br>Common Name | Neodent Instrument Kits<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 | |
| Predicate Device | K171713 - Neodent Instrument Kits, JJGC Indústria e<br>Comércio de Materiais Dentários AS |
| Reference Devices | K142529, Genesis™ Reusable Rigid Sterilization Container<br>System, CareFusion 2200 Inc.<br>K180915, Sonicision Reusable Sterilization Tray, Covidien |

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#### INDICATIONS FOR USE

#### Indications for Use for GM/WS Surgical Kit Case:

Neodent Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instrument Kits are intended to allow sterilization of the enclosed medical devices. Neodent Instrument Kits 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 Kits are intended for sterilization of non-porous loads.

The combined weight of the GM/WS Surgical Kit Case and the associated instruments is 674.5 g. The weight of the empty Kit Case is 507 grams.

Neodent Instrument Kits are recommended not to be stacked during sterilization.

#### Indications for Use for GM Prosthetic Kit Case:

Neodent Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instrument Kits are intended to allow sterilization of the enclosed medical devices. Neodent Instrument Kits 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 Kits are intended for sterilization of non-porous loads. The

The combined weight of the GM Prosthetic Kit Case and the associated instruments is 250.5 g. The weight of the empty Kit Case is 210 grams.

Neodent Instrument Kits are recommended not to be stacked during sterilization.

#### Indications for Use for GM Try-In Kit Case:

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

The kits are to be enclosed in a sterilizable 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 Kits are intended for sterilization of non-porous loads.

The combined weight of the GM Try-In Kit Case and the associated 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 sterilization.

#### Indications for Use for GM Guided Surgery Kit Case:

Neodent Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instrument Kits are intended to allow sterilization of the enclosed medical devices. Neodent Instrument Kits 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

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

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

The combined weight of the GM Guided Surgery Surgical Kit Case and the associated instruments is 728.4 g. The weight of the empty Kit Case is 567 grams.

Neodent Instrument Kits are recommended not to be stacked during sterilization.

#### SUBJECT DEVICE DESCRIPTION

The subject device kits are reusable rigid containers, comprising a case bottom (or base), a removable inner tray base (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 six (6) such kits. The lids are manufactured from injection molded polyphenylsulfone resin, the tray base and case bottoms are manufactured from injection molded polysulfone resin. The designs include grommets of various geometries manufactured from molded silicone that retain the instruments within the tray. Certain designs also incorporate a holder of a single geometry made of Ti-6Al-4V-ELI to position items in the trays. The subject device kits are provided nonsterile to the end- user. The dimensions for each model are presented in the table below:

| Assembled<br>set | Assembled Set<br>Dimension<br>(L x W x H) | Component Number | Component Dimension<br>(L x W x H) |
|------------------|-------------------------------------------|------------------|------------------------------------|
| 110.287 | 264 x 163 x 54 mm | 212.294 (Lid) | 264 x 163 x 43 mm |
| | | 212.310 (Tray) | 248 x 149 x 16 mm |
| | | 212.318 (Bottom) | 256 x 155 x 22 mm |
| 110.294 | 195 x 90 x 54 mm | 212.293 (Lid) | 195 x 90 x 36 mm |
| | | 212.321 (Tray) | 180 x 76 x 17 mm |
| | | 212.197 (Bottom) | 188 x 84 x 32 mm |
| 110.295 | 195 x 90 x 44 mm | 212.293 (Lid) | 195 x 90 x 36 mm |
| | | 212.323 (Tray) | 180 x 76 x 17 mm |
| | | 212.092 (Bottom) | 188 x 84 x 22 mm |
| 110.296 | 264 x 163 x 58 mm | 212.327 (Lid) | 264 x 163 x 49 mm |
| | | 212.320 (Tray) | 248 x 148,5 x 16 mm |
| | | 212.328 (Bottom) | 256 x 155 x 20,5 mm |

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## TECHNOLOGICALCHARACTERISTICCOMPARISONTABLE

| | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | K182865<br>Neodent Instrument Kits<br>JJGC Indústria e Comércio de Materiais<br>Dentários S.A. | K171713<br>Neodent Instrument Kits<br>JJGC Indústria e Comércio de Materiais<br>Dentários S.A. | Comparison |
| Indications<br>for Use | Indications for Use for GM/WS Surgical Kit Case:<br>Neodent Instrument Kits are intended<br>to be used to enclose other medical<br>devices that are to be sterilized by a<br>health care provider. Neodent<br>Instrument Kits are intended to allow<br>sterilization of the enclosed medical<br>devices. Neodent Instrument Kits<br>require the use of FDA cleared wrap to<br>maintain the sterility of the enclosed<br>devices.<br>The kits are to be enclosed in a<br>sterilization wrap that is FDA-cleared for<br>the indicated cycles, and moist heat<br>(steam) sterilized using one of the<br>following cycles:<br>Fractionated vacuum (pre-vacuum) –<br>Exposure at 132 °C for 4 minutes, 20<br>minute dry time.<br>Gravity displacement – Exposure at 132<br>°C for 15 minutes, 20 minute dry time<br>Neodent Instrument Kits are intended<br>for sterilization of non-porous loads.<br>The combined weight of the GM/WS<br>Surgical Kit Case and the associated<br>instruments is 674.5 g. The weight of the<br>empty Kit Case is 507 grams.<br>Neodent Instrument Kits are<br>recommended not to be stacked during<br>sterilization. | Neodent Instrument Kits are intended to<br>be used to enclose other medical<br>devices that are to be sterilized by a<br>health care provider. Neodent<br>Instrument Kits are intended to allow<br>sterilization of the enclosed medical<br>devices. Neodent Instrument Kits<br>require the use of FDA cleared wrap to<br>maintain the sterility of the enclosed<br>devices.<br>The kits are to be enclosed in a<br>sterilization wrap that is FDA-cleared<br>for the indicated cycles, and moist heat<br>(steam) sterilized using one of the<br>following cycles:<br>Fractionated vacuum (pre-vacuum) –<br>Exposure at 132 °C for 4 minutes, 20<br>minute dry time<br>Gravity displacement – Exposure at 132<br>°C for 15 minutes, 20 minute dry time<br>Neodent Instrument Kits are<br>intended for sterilization of<br>non-porous loads.<br>The GM/WS Surgical Kit Case<br>maximum load weight is 125 grams.<br>The GM Surgical Kit Case maximum load<br>weight is 113 grams.<br>Neodent Instrument Kits are<br>recommended not to be stacked during<br>sterilization. | Similar |

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| SUBJECT DEVICE<br>K182865<br>Neodent Instrument Kits<br>JJGC Indústria e Comércio de Materiais<br>Dentários S.A. | PRIMARY PREDICATE DEVICE<br>K171713<br>Neodent Instrument Kits<br>JJGC Indústria e Comércio de Materiais<br>Dentários S.A. | Comparison |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|------------|
| Indications for Use for GM Prosthetic<br>Kit Case:<br>Neodent Instrument Kits are intended<br>to be used to enclose other medical<br>devices that are to be sterilized by a<br>health care provider. Neodent<br>Instrument Kits are intended to allow<br>sterilization of the enclosed medical<br>devices. Neodent Instrument Kits<br>require the use of FDA-cleared wrap<br>to maintain the sterility of the<br>enclosed devices.<br><br>The kits are to be enclosed in a<br>sterilization wrap that is FDA-cleared<br>for the indicated cycles, and moist<br>heat (steam) sterilized using one of<br>the following cycles:<br><br>Fractionated vacuum (pre-vacuum) –<br>Exposure at 132 °C for 4 minutes, 20-<br>minute dry time<br><br>Gravity displacement – Exposure at<br>132 °C for 15 minutes, 20-minute dry<br>time.<br><br>Neodent Instrument Kits are intended<br>for sterilization of non-porous loads.<br><br>The combined weight of the GM<br>Prosthetic Kit Case and the associated<br>instruments is 250.5 g. The weight of<br>the empty Kit Case is 210 grams.<br><br>Neodent Instrument Kits are<br>recommended not to be stacked<br>during sterilization. | | |

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| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|------------|
| K182865<br>Neodent Instrument Kits<br>JJGC Indústria e Comércio de Materiais<br>Dentários S.A. | K171713<br>Neodent Instrument Kits<br>JJGC Indústria e Comércio de Materiais<br>Dentários S.A. | Comparison |
| Indications for Use for GM Try-In Kit<br>Case: | | |
| Neodent Instrument Kits are intended<br>to be used to enclose other medical<br>devices that are to be sterilized by a<br>health care provider Neodent<br>Instrument Kits require the use of FDA-<br>cleared wrap to maintain the sterility of<br>the enclosed devices. | | |
| The kits are to be enclosed in a<br>sterilizable wrap that is FDA-cleared for<br>the indicated cycles, and moist heat<br>(steam) sterilized using one of the<br>following cycles: | | |
| Fractionated vacuum (pre-vacuum) -<br>Exposure at 132 °C for 4 minutes, 20-<br>minute dry time. | | |
| Gravity displacement – Exposure at 132<br>ºC for 15 minutes, 20-minute dry time. | | |
| Neodent Instrument Kits are intended<br>for sterilization of non-porous loads. | | |
| The combined weight of the GM Try-In<br>Kit Case and the associated instruments<br>is 212.6 g. The weight of the empty Kit<br>Case is 195 grams. | | |
| Neodent Instrument Kits are<br>recommended not to be stacked during<br>sterilization. | | |

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| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| K182865<br>Neodent Instrument Kits<br>JJGC Indústria e Comércio de Materiais<br>Dentários S.A. | K171713<br>Neodent Instrument Kits<br>JJGC Indústria e Comércio de Materiais<br>Dentários S.A. | Comparison | |
| Indications for Use for GM Guided<br>Surgery Kit Case:<br>Neodent Instrument Kits are intended<br>to be used to enclose other medical<br>devices that are to be sterilized by a<br>health care provider. Neodent<br>Instrument Kits are intended to allow<br>sterilization of the enclosed medical<br>devices. Neodent Instrument Kits<br>require the use of FDA-cleared wrap to<br>maintain the sterility of the enclosed<br>devices.<br><br>The kits are to be enclosed in a<br>sterilization wrap that is FDA-cleared for<br>the indicated cycles, and moist heat<br>(steam) sterilized using one of the<br>following cycles:<br>Fractionated vacuum (pre-vacuum) –<br>Exposure at 132 °C for 4 minutes, 20-<br>minute dry time<br><br>Gravity displacement – Exposure at 132<br>°C for 15 minutes, 40-minute dry time.<br><br>Neodent Instrument Kits are intended<br>for sterilization of non-porous loads.<br><br>The combined weight of the GM Guided<br>Surgery Surgical Kit Case and the<br>associated instruments is 728.4 g. The<br>weight of the empty Kit Case is 567<br>grams.<br><br>Neodent Instrument Kits are<br>recommended not to be stacked during<br>sterilization. | | | |
| | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | |
| | K182865<br>Neodent Instrument Kits<br>JJGC Indústria e Comércio de Materiais<br>Dentários S.A. | K171713<br>Neodent Instrument Kits<br>JJGC Indústria e Comércio de Materiais<br>Dentários S.A. | Comparison |
| Intended Use | Neodent Instrument Kits are intended to be used<br>to enclose other medical devices that are to be<br>sterilized by a health care provider. Neodent<br>Instrument Kits are intended to allow sterilization<br>of the enclosed medical devices. Neodent<br>Instrument Kits require the use of FDA cleared<br>wrap to maintain the sterility of the enclosed<br>devices. | Neodent Instrument Kits are intended to<br>be used to enclose other medical devices<br>that are to be sterilized by a health care<br>provider. Neodent Instrument Kits are<br>intended to allow sterilization of the<br>enclosed medical devices. Neodent<br>Instrument Kits require the use of FDA<br>cleared wrap to maintain the sterility of<br>the enclosed devices. | Same |
| Product Code | KCT | KCT | Same |
| Design | Rigid polysulfone polymer base and<br>removable inner tray with a<br>polyphenylsulfone lid. | Rigid polysulfone polymer base and<br>removable inner tray with a<br>polyphenylsulfone lid. | Same |
| | Retention grommets of medical grade silicone. | Retention grommets of medical grade<br>silicone. | |
| | Retention fixtures of titanium alloy. | Retention fixtures of titanium alloy. | |
| Perforated | Yes; allows moist heat (steam) penetration<br>to achieve sterilization | Yes; allows moist heat (steam)<br>penetration to achieve sterilization | Same |
| Reusable | Yes | Yes | Same |
| Overall<br>dimensions | For 110.295: 195 L x 90 W x 44 H, mm<br>For 110.294: 195L x 90 W x 54 H, mm<br>For 110.287: 264L x 163 W x 54 H, mm<br>For 110.296: 264 L x 163 W x 58 H, mm | 264 L x 163 W x 54 H, mm | Similar |
| Vent to Volume<br>Ratio | 110.296: 0.0093 cm2 / cm3 (0.0236 in2 / in3)<br>110.287: 0.0102 cm2 / cm3 (0.0259 in2 / in3)<br>110.294: 0.0191 cm2 / cm3 (0.0485 in2 / in3)<br>110.295: 0.0247 cm2 / cm3 (0.0627 in2 / in3) | 0.0102 cm2 / cm3 (0.0259 in2 / in3) | Similar |
| Useful Life | Yes, reusable up to 100 cycles<br>Assembled/disassembled, cleaned,<br>sterilized<br>Visual inspection Component dimensional fit<br>verification<br>Functional closure (lid-base latch) verification | Yes, reusable up to 100 cycles<br>Assembled/disassembled, cleaned,<br>sterilized<br>Visual inspection<br>Component dimensional fit verification<br>Functional closure (lid-base latch) | Same |
| Biocompatibility | The assessment to Biocompatibility was<br>performed per ISO 10993-1 and testing was<br>performed using methods described in<br>AAMI/ANSI/ISO 10993-5. The results indicate that<br>the subject devices are biocompatible. | The assessment to Biocompatibility was<br>performed per ISO 10993-1 and testing<br>was performed using methods described<br>in AAMI/ANSI/ISO 10993-5. The results<br>indicate that the subject devices are<br>biocompatible. | Same |
| Sterilization<br>Method | Moist heat (steam) | Moist heat (steam) | Same |
| | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | |
| | Neodent Instrument Kits<br>JJGC Indústria e Comércio de Materiais<br>Dentários S.A. | K171713<br>Neodent Instrument Kits<br>JJGC Indústria e Comércio de Materiais<br>Dentários S.A. | Comparison |
| Cycles | Gravity displacement…