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 (or 40 minutes for model number 110.296)

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

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.

AI/ML Overview

The provided text does not contain information about an AI/algorithm-based device. Instead, it describes a traditional medical device submission for "Neodent Instrument Kits," which are sterilization trays. As such, the concept of a "test set," "training set," "ground truth," "MRMC comparative effectiveness study," or "AI assistance" is not applicable.

The document focuses on demonstrating substantial equivalence to a predicate device (K171713) for a Class II medical device (Sterilization Wrap) under product code KCT.

However, I can extract information related to the performance testing and acceptance criteria for this physical medical device, which is how it meets its intended use.

Here's an interpretation of the document's content relevant to acceptance criteria and performance:

The "Neodent Instrument Kits" are reusable rigid containers intended to enclose other medical devices for sterilization by a healthcare provider. The kits themselves must allow sterilization of the enclosed medical devices and maintain their sterility with an FDA-cleared wrap.

The study proves that the device meets acceptance criteria through a series of non-clinical performance tests, demonstrating its suitability for its intended use and substantial equivalence to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document implicitly defines acceptance criteria through the "Purpose of the Testing" and the "Results" sections. The "Conclusion" explicitly states that the device "performs as well as or better than the legally marketed device K171713."

Acceptance Criteria (Implied from Purpose of Testing)	Reported Device Performance
Manual Cleaning Validation: Device can be effectively cleaned manually.	Passed (Custom test)
Sterilization Validation (Sterilant Penetration and Drying Time): Device allows complete sterilization of enclosed items and dries effectively within specified cycles.	Passed (ANSI/AAMI/ISO 17665-1, ANSI/AAMI/ISO 17665-2)
Life Cycle (Simulate Usage) Testing: Device maintains functionality and integrity over its specified reusable life.	Passed (Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff)
Cytotoxicity Testing: Device materials are not harmful to cells.	Passed (ANSI/AAMI/ISO 10993-5)
Biocompatibility: Device materials are biologically compatible with the body (implicitly, indirectly, through contact with other medical devices).	Passed (Assessment per ISO 10993-1, testing per AAMI/ANSI/ISO 10993-5. Results indicate biocompatibility.)
Intended Use Equivalence: Device performs its intended function (enclosing medical devices for sterilization, allowing sterilization, and maintaining sterility with wrap) comparably to the predicate device.	"Same" as predicate (K171713) for Intended Use. Performance demonstrated via non-clinical testing.
Sterilization Cycles and Parameters: Device is compatible with specified steam sterilization cycles (Fractionated vacuum and Gravity displacement) at defined temperatures and times.	Successfully demonstrated effectiveness for specified cycles and parameters (132 °C; 4 min exposure, 20 min dry for pre-vacuum; 132 °C; 15 min exposure, 20 or 40 min dry for gravity).
Reusable Life: Device can be reused for up to 100 cycles after assembly/disassembly, cleaning, and sterilization, verified by visual inspection, dimensional fit, and functional closure.	"Yes, reusable up to 100 cycles" (Same as predicate)

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the "sample size" in terms of number of devices tested for each non-clinical performance pathway. This type of information is typically found in the full test reports, not a 510(k) summary. However, it implicitly refers to "the device" (singular, representing the device line) being tested.

Test Set/Sample Size: Not explicitly stated as a numerical count of individual devices tested, but the results refer to the performance of "the device" and "the subject devices." For physical device testing, a representative sample is used, but the exact number isn't in this summary.
Data Provenance: The study was conducted by JJGC Indústria e Comércio de Materiais Dentários S.A. (manufacturer and sponsor) located in Curitiba, Parana, Brazil. The data would be considered retrospective in the context of the 510(k) submission, as it describes tests already performed to support the marketing application.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This question is not applicable as the device is a physical sterilization tray, not an AI/algorithm-based device requiring expert interpretation of diagnostic images or similar data. The "ground truth" (e.g., sterility, cleanliness, material biocompatibility) is established through standardized laboratory testing methods, not expert consensus in an observational study.

4. Adjudication Method for the Test Set

Not applicable. As a physical device undergoing laboratory performance testing, "adjudication" in the sense of reconciling expert opinions on complex data (common in AI studies) is not relevant. Test results are typically objective measurements or qualitative observations (e.g., pass/fail based on predefined criteria in the standards).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

Not applicable. MRMC studies are used for diagnostic interpretation systems (often involving AI) to assess how human reader performance changes with or without AI assistance. This device is a physical sterilization tray.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done

Not applicable. This device is not an algorithm. Its "standalone" performance would be its functional performance as a physical object, which is what the non-clinical tests assess (e.g., its ability to withstand sterilization cycles, its material properties).

7. The Type of Ground Truth Used

For this physical device, the "ground truth" is derived from several objective and validated methods:

Sterility Assurance: Demonstrated by challenging the device with biological indicators (or similar methods) and showing complete kill of microorganisms, consistent with ANSI/AAMI/ISO 17665-1/2 standards.
Physical Integrity & Functionality: Demonstrated by visual inspection, component dimensional fit verification, and functional closure verification after repeated cycles of cleaning and sterilization, as per "Life cycle (simulate usage) testing" guidance.
Biocompatibility: Demonstrated by standardized cytotoxicity testing (ANSI/AAMI/ISO 10993-5) and broader biocompatibility assessment (ISO 10993-1).
Cleanliness: Demonstrated by manual cleaning validation methods.

These methods establish the "truth" of the device's performance against recognized industry standards and regulatory guidance.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this physical medical device.

Summary

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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

{1}------------------------------------------------

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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:

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)

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 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)	☑
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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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

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)

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.

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)
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.

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 SAAv. Juscelino Kubitschek de Oliveira, 3291Curitiba, Parana, Brazil 81270-200Registration No.: 3008261720Owner/Operator No.: 10031702
Contact Person	Jennifer M. Jackson, MSDirector of Regulatory Affairs & Quality,Straumann USAE-Mail: jennifer.jackson@straumann.comTelephone (978) 747-2509
Date Prepared	30/Apr/2019
Preparer / Alternate Contact	Mariana Soares HartmannRegulatory Affairs AnalystE-Mail: mariana.hartmann@neodent.com
DEVICE NAME AND CLASSIFICATION
Trade/ Proprietary NameCommon Name	Neodent Instrument KitsInstrument Sterilization Trays
Classification NameAccessories	Sterilization Wrap Containers, Trays, Cassettes & Other
Classification RegulationsProduct Code	21 CFR 880.6850, Class IIKCT
Classification PanelReviewing Branch	General HospitalInfection Control Devices Branch
PREDICATE DEVICE INFORMATION
Predicate Device	K171713 - Neodent Instrument Kits, JJGC Indústria eComércio de Materiais Dentários AS
Reference Devices	K142529, Genesis™ Reusable Rigid Sterilization ContainerSystem, CareFusion 2200 Inc.K180915, Sonicision Reusable Sterilization Tray, Covidien

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

INDICATIONS FOR USE

Indications for Use for GM/WS Surgical Kit Case:

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:

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

{8}------------------------------------------------

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

Assembledset	Assembled SetDimension(L x W x H)	Component Number	Component Dimension(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

{9}------------------------------------------------

TECHNOLOGICALCHARACTERISTICCOMPARISONTABLE

	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE
	K182865Neodent Instrument KitsJJGC Indústria e Comércio de MateriaisDentários S.A.	K171713Neodent Instrument KitsJJGC Indústria e Comércio de MateriaisDentários S.A.	Comparison
Indicationsfor Use	Indications for Use for GM/WS Surgical Kit Case:Neodent Instrument Kits are intendedto be used to enclose other medicaldevices that are to be sterilized by ahealth care provider. NeodentInstrument Kits are intended to allowsterilization of the enclosed medicaldevices. Neodent Instrument Kitsrequire the use of FDA cleared wrap tomaintain the sterility of the encloseddevices.The kits are to be enclosed in asterilization wrap that is FDA-cleared forthe indicated cycles, and moist heat(steam) sterilized using one of thefollowing cycles:Fractionated vacuum (pre-vacuum) –Exposure at 132 °C for 4 minutes, 20minute dry time.Gravity displacement – Exposure at 132°C for 15 minutes, 20 minute dry timeNeodent Instrument Kits are intendedfor sterilization of non-porous loads.The combined weight of the GM/WSSurgical Kit Case and the associatedinstruments is 674.5 g. The weight of theempty Kit Case is 507 grams.Neodent Instrument Kits arerecommended not to be stacked duringsterilization.	Neodent Instrument Kits are intended tobe used to enclose other medicaldevices that are to be sterilized by ahealth care provider. NeodentInstrument Kits are intended to allowsterilization of the enclosed medicaldevices. Neodent Instrument Kitsrequire the use of FDA cleared wrap tomaintain the sterility of the encloseddevices.The kits are to be enclosed in asterilization wrap that is FDA-clearedfor the indicated cycles, and moist heat(steam) sterilized using one of thefollowing cycles:Fractionated vacuum (pre-vacuum) –Exposure at 132 °C for 4 minutes, 20minute dry timeGravity displacement – Exposure at 132°C for 15 minutes, 20 minute dry timeNeodent Instrument Kits areintended for sterilization ofnon-porous loads.The GM/WS Surgical Kit Casemaximum load weight is 125 grams.The GM Surgical Kit Case maximum loadweight is 113 grams.Neodent Instrument Kits arerecommended not to be stacked duringsterilization.	Similar

{10}------------------------------------------------

SUBJECT DEVICEK182865Neodent Instrument KitsJJGC Indústria e Comércio de MateriaisDentários S.A.	PRIMARY PREDICATE DEVICEK171713Neodent Instrument KitsJJGC Indústria e Comércio de MateriaisDentários S.A.	Comparison
Indications for Use for GM ProstheticKit Case:Neodent Instrument Kits are intendedto be used to enclose other medicaldevices that are to be sterilized by ahealth care provider. NeodentInstrument Kits are intended to allowsterilization of the enclosed medicaldevices. Neodent Instrument Kitsrequire the use of FDA-cleared wrapto maintain the sterility of theenclosed devices.The kits are to be enclosed in asterilization wrap that is FDA-clearedfor the indicated cycles, and moistheat (steam) sterilized using one ofthe following cycles:Fractionated vacuum (pre-vacuum) –Exposure at 132 °C for 4 minutes, 20-minute dry timeGravity displacement – Exposure at132 °C for 15 minutes, 20-minute drytime.Neodent Instrument Kits are intendedfor sterilization of non-porous loads.The combined weight of the GMProsthetic Kit Case and the associatedinstruments is 250.5 g. The weight ofthe empty Kit Case is 210 grams.Neodent Instrument Kits arerecommended not to be stackedduring sterilization.

{11}------------------------------------------------

SUBJECT DEVICE	PRIMARY PREDICATE DEVICE
K182865Neodent Instrument KitsJJGC Indústria e Comércio de MateriaisDentários S.A.	K171713Neodent Instrument KitsJJGC Indústria e Comércio de MateriaisDentários S.A.	Comparison
Indications for Use for GM Try-In KitCase:
Neodent Instrument Kits are intendedto be used to enclose other medicaldevices that are to be sterilized by ahealth care provider NeodentInstrument Kits require the use of FDA-cleared wrap to maintain the sterility ofthe enclosed devices.
The kits are to be enclosed in asterilizable wrap that is FDA-cleared forthe indicated cycles, and moist heat(steam) sterilized using one of thefollowing cycles:
Fractionated vacuum (pre-vacuum) -Exposure at 132 °C for 4 minutes, 20-minute dry time.
Gravity displacement – Exposure at 132ºC for 15 minutes, 20-minute dry time.
Neodent Instrument Kits are intendedfor sterilization of non-porous loads.
The combined weight of the GM Try-InKit Case and the associated instrumentsis 212.6 g. The weight of the empty KitCase is 195 grams.
Neodent Instrument Kits arerecommended not to be stacked duringsterilization.

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SUBJECT DEVICE	PRIMARY PREDICATE DEVICE
K182865Neodent Instrument KitsJJGC Indústria e Comércio de MateriaisDentários S.A.	K171713Neodent Instrument KitsJJGC Indústria e Comércio de MateriaisDentários S.A.	Comparison
Indications for Use for GM GuidedSurgery Kit Case:Neodent Instrument Kits are intendedto be used to enclose other medicaldevices that are to be sterilized by ahealth care provider. NeodentInstrument Kits are intended to allowsterilization of the enclosed medicaldevices. Neodent Instrument Kitsrequire the use of FDA-cleared wrap tomaintain the sterility of the encloseddevices.The kits are to be enclosed in asterilization wrap that is FDA-cleared forthe indicated cycles, and moist heat(steam) sterilized using one of thefollowing cycles:Fractionated vacuum (pre-vacuum) –Exposure at 132 °C for 4 minutes, 20-minute dry timeGravity displacement – Exposure at 132°C for 15 minutes, 40-minute dry time.Neodent Instrument Kits are intendedfor sterilization of non-porous loads.The combined weight of the GM GuidedSurgery Surgical Kit Case and theassociated instruments is 728.4 g. Theweight of the empty Kit Case is 567grams.Neodent Instrument Kits arerecommended not to be stacked duringsterilization.
	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE
	K182865Neodent Instrument KitsJJGC Indústria e Comércio de MateriaisDentários S.A.	K171713Neodent Instrument KitsJJGC Indústria e Comércio de MateriaisDentários S.A.	Comparison
Intended Use	Neodent Instrument Kits are intended to be usedto enclose other medical devices that are to besterilized by a health care provider. NeodentInstrument Kits are intended to allow sterilizationof the enclosed medical devices. NeodentInstrument Kits require the use of FDA clearedwrap to maintain the sterility of the encloseddevices.	Neodent Instrument Kits are intended tobe used to enclose other medical devicesthat are to be sterilized by a health careprovider. Neodent Instrument Kits areintended to allow sterilization of theenclosed medical devices. NeodentInstrument Kits require the use of FDAcleared wrap to maintain the sterility ofthe enclosed devices.	Same
Product Code	KCT	KCT	Same
Design	Rigid polysulfone polymer base andremovable inner tray with apolyphenylsulfone lid.	Rigid polysulfone polymer base andremovable inner tray with apolyphenylsulfone lid.	Same
	Retention grommets of medical grade silicone.	Retention grommets of medical gradesilicone.
	Retention fixtures of titanium alloy.	Retention fixtures of titanium alloy.
Perforated	Yes; allows moist heat (steam) penetrationto achieve sterilization	Yes; allows moist heat (steam)penetration to achieve sterilization	Same
Reusable	Yes	Yes	Same
Overalldimensions	For 110.295: 195 L x 90 W x 44 H, mmFor 110.294: 195L x 90 W x 54 H, mmFor 110.287: 264L x 163 W x 54 H, mmFor 110.296: 264 L x 163 W x 58 H, mm	264 L x 163 W x 54 H, mm	Similar
Vent to VolumeRatio	110.296: 0.0093 cm2 / cm3 (0.0236 in2 / in3)110.287: 0.0102 cm2 / cm3 (0.0259 in2 / in3)110.294: 0.0191 cm2 / cm3 (0.0485 in2 / in3)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 cyclesAssembled/disassembled, cleaned,sterilizedVisual inspection Component dimensional fitverificationFunctional closure (lid-base latch) verification	Yes, reusable up to 100 cyclesAssembled/disassembled, cleaned,sterilizedVisual inspectionComponent dimensional fit verificationFunctional closure (lid-base latch)	Same
Biocompatibility	The assessment to Biocompatibility wasperformed per ISO 10993-1 and testing wasperformed using methods described inAAMI/ANSI/ISO 10993-5. The results indicate thatthe subject devices are biocompatible.	The assessment to Biocompatibility wasperformed per ISO 10993-1 and testingwas performed using methods describedin AAMI/ANSI/ISO 10993-5. The resultsindicate that the subject devices arebiocompatible.	Same
SterilizationMethod	Moist heat (steam)	Moist heat (steam)	Same
	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE
	Neodent Instrument KitsJJGC Indústria e Comércio de MateriaisDentários S.A.	K171713Neodent Instrument KitsJJGC Indústria e Comércio de MateriaisDentários S.A.	Comparison
Cycles	Gravity displacement	Gravity displacement	Same
	Fractionated vacuum (pre-vacuum)	Fractionated vacuum (pre-vacuum)
Parameters	GravitySterilization temperature: 132 °CSterilization time: 15 minutes;Drying time: 20 minutes or 40minutes (model number 110.296)	GravitySterilization temperature: 132 °CSterilization time: 15 minutes;Drying time: 20 minutes	Similar
	Pre-VacuumSterilization temperature: 132 °CSterilization time: 4 minutes;Drying time: 20 minutes.	Pre-VacuumSterilization temperature: 132 °CSterilization time: 4 minutes;Drying time: 20 minutes.

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The subject devices and the primary predicate device K171713 have the same intended use, the same product classification and product code (KCT) and have same Indications for Use statements. The subject devices (and the primary predicate device per K171713) are reusable rigid containers used to organize and protect the dental surgical instruments that are sterilized by the healthcare provider. The subject device and the primary predicate device K171713 components are perforated to allow for penetration of the moist heat (steam) sterilant and require the use of an FDA-cleared wrap or pouch to maintain sterility.

The subject device and the primary predicate device K171713 include components manufactured from polyphenylsulfone, polysulfone and silicone. The subject device also contains a holder fabricated from titanium alloy; while this differs from the predicate it is noted that certain instruments to be contained within the predicate cleared in K171713 are made of the same alloy. The subject device is provided in multiple sizes and configurations, whereas the primary predicate device K171713 is provided in a single size and two configurations.

The reference device cleared in K14259 was used to support the device dimensions and vent to volume ratio. The reference device cleared inK180915 was used to support the sterilization drying time of 40 minutes.

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NON-CLINICAL PERFORMANCE DATA

Standard or Test Method	Purpose of the Testing	Results
Custom	Manual cleaning validation	Passed
ANSI/AAMI/ISO 17665-1ANSI/AAMI/ISO 17665-2	Sterilization validation, including sterilant penetration and drying time	Passed
Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff	Life cycle (simulate usage) testing	Passed
ANSI/AAMI/ISO 10993-5(Cytotoxicity)	Cytotoxicity testing	Passed

CONCLUSION

The conclusions drawn from the nonclinical data demonstrate that the device is as sffective, and performs as well as or better than the legally marketed device K171713.

Regulation Number and Section

§ 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).