Complement Kit Cases

K230804 · JJGC Indústria e Comércio de Materiais Dentários S.A. · KCT · Jul 7, 2023 · General Hospital

Device Facts

• Record ID: K230804
• Device Name: Complement Kit Cases
• Applicant: JJGC Indústria e Comércio de Materiais Dentários S.A.
• Product Code: KCT · General Hospital
• Decision Date: Jul 7, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

Neodent Instrument Kit Cases are indicated for organization of surgical and/or prosthetic instruments during sterilization, storage and transport. The use of this product facilitates storage and organization of instruments during and after surgical procedures. 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 using one of the following cycles: Dynamic Air Removal (pre-vacuum)- Exposure at 132 ℃ for 4 minutes, 30-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 Complement Case and the associated instruments is 75,7 g. The weight of the empty Kit Case is 53.62 grams. Neodent Instrument Kit Cases should not be stacked during sterilization. Nuvo™ Instrument Kit Cases are indicated for organization of surgical and/or prosthetic instruments during sterilization, storage and transport. The use of this product facilitates storage and organization of instruments during and after surgical procedures. Nuvo™ Instrument Kit Cases are intended to allow sterilization of the enclosed medical devices. Nuvo™ 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 using one of the following cycles: Dynamic Air Removal (pre-vacuum)- Exposure at 132 ℃ for 4 minutes, 30-minute dry time. Gravity displacement - Exposure at 132 °C for 15 minutes, 20-minute dry time. Nuvo™ Instrument Kit Cases are intended for sterilization of non-porous loads. The combined weight of the Complement Case and the associated instruments is 75.7 g. The weight of the empty Kit Case is 52.72 grams. Nuvo™ Instrument Kit Cases should not be stacked during sterilization.

Device Story

Complement Kit Cases are rigid, reusable storage containers for dental surgical and prosthetic instruments; constructed from autoclavable polysulfone base and polyphenylsulfone lid with silicone instrument holders. Used in dental clinics to organize instruments during sterilization, storage, and transport. Device is perforated to allow steam penetration; requires FDA-cleared sterilization wrap to maintain sterility. Operated by healthcare providers; instruments are placed in the case, wrapped, and processed in an autoclave. Output is a sterilized, organized kit ready for surgical use. Benefits include streamlined instrument management and protection during sterilization cycles. Validated for 100 reuse cycles.

Clinical Evidence

Bench testing only. Validation included manual cleaning (AAMI TIR30:2011), sterilization efficacy (ISO 17665-1, SAL 10^-6), life cycle testing (100 cycles), and biocompatibility (ISO 10993-1/5). All tests met acceptance criteria.

Technological Characteristics

Materials: Polysulfone (base), polyphenylsulfone (lid), medical-grade silicone (holders). Design: Perforated rigid container. Sterilization: Moist heat (steam) autoclave. Reusability: Up to 100 cycles. Connectivity: None. Software: None.

Indications for Use

Indicated for organization, storage, and transport of surgical and/or prosthetic instruments during sterilization procedures in healthcare settings. Intended for use with non-porous loads in steam sterilization cycles (pre-vacuum or gravity displacement) when enclosed in FDA-cleared sterilization wrap.

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)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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

## Re: K230804

Trade/Device Name: Complement Kit Cases Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: June 5, 2023 Received: June 5, 2023

## 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 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

July 7, 2023

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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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Eileen
Digitally signed by
Eileen Cadel -S
Date: 2023.07.07
Cadel -S 12:15:20-04'00'

for

Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K230804

Device Name Complement Kit Cases

#### Indications for Use (Describe)

Indications for Use for Neodent Complement Kit Cases:

Neodent Instrument Kit Cases are indicated for organization of surgical and/or prosthetic instruments during sterilization, storage and transport. The use of this product facilitates storage and organization of instruments during and after surgical procedures. 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 using one of the following cycles:

Dynamic Air Removal (pre-vacuum)- Exposure at 132 ℃ for 4 minutes, 30-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 Complement Case and the associated instruments is 75,7 g. The weight of the empty Kit Case is 53.62 grams.

Neodent Instrument Kit Cases should not be stacked during sterilization.

Indications for Use for Nuvo Complement Kit Cases:

Nuvo™ Instrument Kit Cases are indicated for organization of surgical and/or prosthetic instruments during sterilization, storage and transport. The use of this product facilitates storage and organization of instruments during and after surgical procedures. Nuvo™ Instrument Kit Cases are intended to allow sterilization of the enclosed medical devices. Nuvo™ 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 using one of the following cycles:

Dynamic Air Removal (pre-vacuum)- Exposure at 132 ℃ for 4 minutes, 30-minute dry time.

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

Nuvo™ Instrument Kit Cases are intended for sterilization of non-porous loads. The combined weight of the Complement Case and the associated instruments is 75.7 g. The weight of the empty Kit Case is 52.72 grams.

Nuvo™ Instrument Kit Cases should not be stacked during sterilization.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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### 510(K) Summary

#### ADMINISTRATIVE INFORMATION

| Sponsor | JJGC Indústria e Comércio de Materiais Dentários SA<br>(dba Neodent)<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,<br>Straumann USA<br>E-mail: [e-mail]<br>Telephone [phone] |
| Date Prepared | 7 July 2023 |
| Preparer / Alternate<br>Contact | Bárbara Uzae<br>Regulatory Affairs Analyst<br>JJGC Indústria e Comércio de Materiais Dentários SA<br>E-mail: [e-mail] |

#### DEVICE NAME AND CLASSIFICATION

Product Code

| Trade/ Proprietary Name | Complement Kit Cases |
|------------------------------|----------------------------------------------------------|
| Common Name | Instrument Sterilization Trays |
| Classification Name | Sterilization Wrap Containers, Trays, Cassettes & Other |
| Classification Regulations | 21 CFR 880.6850, Class II |
| Product Code | KCT |
| Classification Panel | General Hospital |
| Reviewing Branch | Infection Control Devices Branch |
| PREDICATE DEVICE INFORMATION | |
| Primary Predicate Device | K182865 – Neodent Instrument Kit Cases, JJGC Indústria e |

#### Comércio de Materiais Dentários S.A Classification Name Sterilization Wrap Containers, Trays, Cassettes & Other 21 CFR 880.6850, Class II Classification Regulation

КСТ

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#### INDICATIONS FOR USE

#### Indications for Use for Neodent Complement Kit Cases:

Neodent Instrument Kit Cases are indicated for organization of surgical and/or prosthetic instruments during sterilization, storage and transport. The use of this product facilitates storage and organization of instruments during and after surgical procedures. 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:

Dynamic Air Removal (pre-vacuum)- Exposure at 132 °C for 4 minutes, 30-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 Complement Case and the associated instruments is 75.7 g. The weight of the empty Kit Case is 53.62 grams.

Neodent Instrument Kit Cases should not be stacked during sterilization.

#### Indications for Use for Nuvo Complement Kit Cases:

Nuvo™ Instrument Kit Cases are indicated for organization of surgical and/or prosthetic instruments during sterilization, storage and transport. The use of this product facilitates storage and organization of instruments during and after surgical procedures. Nuvo™ Instrument Kit Cases are intended to allow sterilization of the enclosed medical devices. Nuvo™ 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:

Dynamic Air Removal (pre-vacuum)- Exposure at 132 °C for 4 minutes, 30-minute dry time. Gravity displacement - Exposure at 132 °C for 15 minutes, 20-minute dry time.

Nuvo™ Instrument Kit Cases are intended for sterilization of non-porous loads. The combined weight of the Complement Case and the associated instruments is 75.7 g. The weight of the empty Kit Case is 52.72 grams.

Nuvo™ Instrument Kit Cases should not be stacked during sterilization.

#### SUBJECT DEVICE DESCRIPTION

The subject devices Complement Kit Cases consist of a storage case for Neodent and Nuvo instruments set. They are made of autoclavable polymer, the case has silicone holders to store and hold each instrument securely during sanitization and surgical procedures. The case can be equipped according to the procedure.

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<br>Number | Component<br>Dimension<br>(L x W x H) |
|-----------------------|------------------------------|------------------------------------------------|---------------------|---------------------------------------|
| 110.335 | Complement Case<br>(model 2) | 81 x 67 x 60 mm | 212.304 (Lid) | 50 x 80 x 30 mm |
| | | | 212.087 (Base) | 59 x 81 x 35 mm |
| CD1099002 | Complement Case<br>(model 2) | 81 x 67 x 60 mm | 702989 (Lid) | 58 x 80 x 30 mm |
| | | | 212.087 (Base) | 59 x 81 x 35 mm |

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

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## TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLE

| | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | | |
|-------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| | Complement Kit Cases<br>JJGC Indústria e Comércio de Materiais Dentários S.A. | K182865<br>Neodent Instrument Kit Cases<br>JJGC Indústria e Comércio de Materiais Dentários S.A. | COMPARISON | |
| Indications for<br>Use Statement | Indications for Use for Neodent Complement Kit Cases:<br>Neodent Instrument Kit Cases are indicated for organization of surgical and/or<br>prosthetic instruments during sterilization, storage and transport. The use of<br>this product facilitates storage and organization of instruments during and<br>after surgical procedures. Neodent Instrument Kit Cases are intended to allow<br>sterilization of the enclosed medical devices. Neodent Instrument Kit Cases<br>require the use of FDA cleared wrap to maintain the sterility of the enclosed<br>devices. The kits are to be enclosed in a sterilization wrap that is FDA-cleared<br>for the indicated cycles, and moist heat (steam) sterilized using one of the<br>following cycles:<br>Dynamic Air Removal (pre-vacuum) - Exposure at 132 °C for 4 minutes, 30-<br>minute dry time.<br>Gravity displacement - Exposure at 132 °C for 15 minutes, 20-minute dry time.<br>Neodent Instrument Kit Cases are intended for sterilization of non-porous<br>loads. The combined weight of the Complement Case and the associated<br>instruments is 75.7 g. The weight of the empty Kit Case is 53.62 grams.<br>Neodent Instrument Kit Cases should not be stacked during sterilization.<br><br>Indications for Use for Nuvo Complement Kit Cases:<br>Nuvo™ Instrument Kit Cases are indicated for organization of surgical and/or<br>prosthetic instruments during sterilization, storage and transport. The use of<br>this product facilitates storage and organization of instruments during and<br>after surgical procedures. Nuvo™ Instrument Kit Cases are intended to allow<br>sterilization of the enclosed medical devices. Nuvo™ Instrument Kit Cases<br>require the use of FDA cleared wrap to maintain the sterility of the enclosed<br>devices. The kits are to be enclosed in a sterilization wrap that is FDA-cleared<br>for the indicated cycles, and moist heat (steam) sterilized using one of the<br>following cycles:<br>Dynamic Air Removal (pre-vacuum)- Exposure at 132 °C for 4 minutes, 30-<br>minute dry time.<br>Gravity displacement - Exposure at 132 °C for 15 minutes, 20-minute dry time.<br>Nuvo™ Instrument Kit Cases are intended for sterilization of non-porous loads.<br>The combined weight of the Complement Case and the associated<br>instruments is 75.7 g. The weight of the empty Kit Case is 52.72 grams.<br>Nuvo™ Instrument Kit Cases should not 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 devices that<br>are to be sterilized by a health care provider. Neodent Instrument Kits are intended to<br>allow sterilization of the enclosed medical devices. Neodent Instrument Kits require the<br>use of FDA cleared wrap to maintain the sterility of the enclosed devices. The kits are to<br>be enclosed in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist<br>heat (steam) sterilized using one of the following cycles:<br>Fractionated vacuum (pre-vacuum) - Exposure at 132 °C for 4 minutes, 20 minute dry time<br>Gravity displacement - Exposure at 132 °C for 15 minutes, 20 minute dry time<br>Neodent Instrument Kits are intended for sterilization of non-porous loads. The combined<br>weight of the GM/WS Surgical Kit Case and the associated instruments is 674.5 g. The<br>weight of the empty Kit Case is 507 grams. Neodent Instrument Kits are recommended not<br>to be stacked during sterilization.<br><br>Indications for Use for GM Prosthetic Kit Case:<br>Neodent Instrument Kits are intended to be used to enclose other medical devices that<br>are to be sterilized by a health care provider. Neodent Instrument Kits are intended to<br>allow sterilization of the enclosed medical devices. Neodent Instrument Kits require the<br>use of FDA-cleared wrap to maintain the sterility of the enclosed devices. The kits are to<br>be enclosed in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist<br>heat (steam) sterilized using one of the following cycles:<br>Fractionated vacuum (pre-vacuum) - Exposure at 132 °C for 4 minutes, 20-minute dry time<br>Gravity displacement - Exposure at 132 °C for 15 minutes, 20-minute dry time.<br>Neodent Instrument Kits are intended for sterilization of non-porous loads.<br>The GM Prosthetic Kit Case maximum load weight is 50 grams. Neodent Instrument Kits<br>are recommended not to be stacked during sterilization.<br><br>Indications for Use for GM Try-In Kit Case:<br>Neodent Instrument Kits are intended to be used to enclose other medical devices that<br>are to be sterilized by a health care provider Neodent Instrument Kits require the use of<br>FDA-cleared wrap to maintain the sterility of the enclosed devices. The kits are to be<br>enclosed in a sterilizable wrap that is FDA-cleared for the indicated cycles, and moist heat<br>(steam)sterilized using one of the following cycles:<br>Fractionated vacuum (pre-vacuum) – Exposure at 132 °C for 4 minutes, 20-minute dry<br>time. Gravity displacement - Exposure at 132 ºC for 15 minutes, 20-minute dry time.<br>Neodent Instrument Kits are intended for sterilization of non-porous loads. The combined<br>weight of the GM Try-In Kit Case and the associated instruments is 212.6 g. The weight of<br>the empty Kit Case is 195 grams. Neodent Instrument Kits are recommended not to be<br>stacked during sterilization. | Equivalent<br>Although the language is<br>slightly different, the<br>indications for use are<br>equivalent. Both subject and<br>predicate devices are<br>intended to allow<br>organization and sterilization<br>of the enclosed medical<br>devices. The difference in the<br>text is specific due to the<br>weight of each device in their<br>maximum load configuration. | |
| | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | | |
| | Complement Kit Cases<br>JJGC Indústria e Comércio de Materiais Dentários S.A. | K182865<br>Neodent Instrument Kit Cases<br>JJGC Indústria e Comércio de Materiais Dentários S.A. | COMPARISON | |
| Indications for<br>Use Statement | | Indications for Use for GM Guided Surgery Kit Case:<br>Neodent Instrument Kits are intended to be used to enclose other medical devices that<br>are to be sterilized by a health care provider. Neodent Instrument Kits are intended to<br>allow sterilization of the enclosed medical devices.<br>Neodent Instrument Kits require the use of FDA-cleared wrap to maintain the sterility of<br>the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA-cleared<br>for the indicated cycles, and moist heat (steam)sterilized using one of the following cycles:<br>Fractionated vacuum (pre-vacuum) - Exposure at 132 °C for 4 minutes, 20-minute dry time<br>Gravity displacement - Exposure at 132 °C for 15 minutes, 40-minute dry time. Neodent<br>Instrument Kits are intended for sterilization of non-porous loads. The combined weight<br>of the GM Guided Surgery Surgical Kit Case and the associated instruments is 728.4 g. The<br>weight of the empty Kit Case is 567 grams. Neodent Instrument Kits are recommended not<br>to be stacked during sterilization. | Equivalent<br>Although the language is<br>slightly different , the<br>indications for use are<br>equivalent. Both subject and<br>predicate devices are<br>intended to allow<br>organization and sterilization<br>of the enclosed medical<br>devices. The difference in the<br>text is specific due to the<br>weight of each device in their<br>maximum load configuration. | |
| Intended Use | This product is intended to hold and store surgical and/or prosthetic<br>instruments during their use and sterilization. Use of this product streamlines<br>the storage and organization od instruments during and after the dental<br>procedure. | Neodent Instrument Kits are intended to be used to enclose other medical devices that<br>are to be sterilized by a health care provider. Neodent Instrument Kits are intended to<br>allow sterilization of the enclosed medical devices. Neodent Instrument Kits require the<br>use of FDA cleared wrap to maintain the sterility of the enclosed devices. | Equivalent<br>Subject and predicate<br>device are intended to safe<br>storage surgical instruments<br>and provide support during<br>sterilization. | |
| Device<br>Classification | Class II | Class II | Identical | |
| Classification<br>Name | Sterilization Wrap Containers, Trays, Cassettes & Other | Sterilization Wrap Containers, Trays, Cassettes & Other | Identical | |
| Product Code | NHA | NHA | Identical | |
| Design |…