Microdent Sterilization Cassette

K242023 · Implant Microdent System S.L.U. · KCT · Feb 19, 2025 · General Hospital

Device Facts

• Record ID: K242023
• Device Name: Microdent Sterilization Cassette
• Applicant: Implant Microdent System S.L.U.
• Product Code: KCT · General Hospital
• Decision Date: Feb 19, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

Microdent Sterilization Cassette is intended to organize, protect, and store various dental surgical drills and tools in order to organize and facilitate the sterilization process by allowing steam penetration and air removal. When used in conjunction with FDA-cleared sterilization accessories (wrap, biological indicators, and chemical indicators) in an FDA-cleared sterilizer, sterility of the enclosed medical devices is maintained until used. The sterilization cassette is intended for sterilization in a pre-vacuum steam sterilizer utilizing this recommended cycle: Temperature: 270°F/132°C Exposure time: 4 minutes. Drying time: 20 minutes. The cassettes are not to be stacked during sterilization.

Device Story

Microdent Sterilization Cassette is a reusable container system for dental surgical instruments. It consists of a plastic base and cover with an evenly distributed hole pattern to facilitate steam penetration and air removal during sterilization. Accessories like silicone mats may be used to organize or separate contents. The device is used in clinical settings by dental staff to prepare instruments for sterilization. The cassette is placed in an FDA-cleared pre-vacuum steam sterilizer (132°C for 4 minutes, 20-minute dry time). The cassette, when wrapped with FDA-cleared sterilization wrap, maintains the sterility of the enclosed instruments until use. It benefits patients by ensuring dental tools are properly organized and sterilized, reducing the risk of contamination during surgical procedures.

Clinical Evidence

No clinical data. Bench testing only. Validation included sterilization cycle efficacy (SAL ≤ 10^-6), drying validation (no visible moisture), cleaning validation (protein < 6.4 µg/cm², hemoglobin < 2.2 µg/cm²), and durability testing (100 reprocessing cycles without deformation or corrosion).

Technological Characteristics

Materials: Plastic and metal. Design: Base and cover with evenly distributed hole pattern; includes silicone mats. Sterilization: Pre-vacuum steam (132°C, 4 min exposure, 20 min dry). Standards: ISO 17665-2:2009, ANSI/AAMI/ISO 17665-1:2006, ANSI/AAMI ST77:2013, AAMI TIR30:2011. Reusable. Connectivity: None.

Indications for Use

Indicated for organizing, protecting, and storing dental surgical drills and tools to facilitate steam sterilization in pre-vacuum steam sterilizers. Intended for use with FDA-cleared sterilization accessories (wrap, biological/chemical indicators).

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

• PolyVac Surgical Instrument Delivery System (K012105)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows 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 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.

February 19, 2025

Implant Microdent System S.L.U. Joan Muñoz COO and R&D Director C/Carles Buïgues, 1 1 Pol. Ind. Can Magre Santa Eulalia de Ronçana, Barcelona 08187 Spain

Re: K242023

Trade/Device Name: Microdent Sterilization Cassette Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: January 23, 2025 Received: January 23, 2025

Dear Joan Muñoz:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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

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Sincerely,

Stephen A. Anisko -S

Digitally signed by Stephen A. Anisko -S Date: 2025.02.19 13:34:26 -05'00'

for: Christopher K. Dugard Division Director DHT4C: Division of Infection Control 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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# Indications for Use

510(k) Number (if known) K242023

Device Name Microdent Sterilization Cassette

#### Indications for Use (Describe)

Microdent Sterlization Cassette is intended to organize, protect, and store various dental surgical drills and tools in order to organize and facilitate the sterilization process by allowing steam penetration and air removal.

When used in conjunction with FDA-cleared sterilization accessories (wrap, biological indicators, and chemical indicators) in an FDA-cleared sterilizer, sterility of the enclosed medical devices is maintained until used.

The sterilization cassette is intended for sterilization in a pre-vacuum steam sterilizer utilizing this recommended cycle:

- Temperature: 270°F/132°C

- Exposure time: 4 minutes.
- Drying time: 20 minutes.
- The cassettes are not to be stacked during sterilization.

- KTF and KBE references represent the worst case validated load due to the total weight of 509 grams and 220 grams respectively.

- Implant Microdent System S.L. does not make any lumen claims for the Microdent Sterilization Cassette.

The following list of sterilization cassette models are available and the corresponding instrument load weight that can be sterilized in each model is as listed.

| REFERENCE | WEIGHT | DIMENSIONS | VOLUME TO VENT RATIO |
|-----------|--------|----------------|---------------------------|
| KCIGN | 481g | 190x140x6.5mm | 3.38 mm<br>(0.133 inch) |
| KCIEK | 481g | 190x140x6.5mm | 3.38 mm<br>(0.133 inch) |
| KIO | 450g | 200x105x34mm | 27.737 mm<br>(1.092 inch) |
| KFM | 450g | 190x140x61.5mm | 3.38 mm<br>(0.133 inch) |
| KTF | 509g | 184x136x31mm | 131.98 mm<br>(5.196 inch) |
| KEO | 464g | 190x140x61.5mm | 3.38 mm<br>(0.133 inch) |
| KBE | 220g | 143x79x23mm | 24.36 mm<br>(0.959 inch) |
| KCF | 262g | 143x99.5x61mm | 3.302 mm<br>(0.130 inch) |

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.

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Image /page/5/Picture/0 description: The image shows the logo for Microdent Implant System. The logo features the letters "MD" inside of a circle, with three additional circles trailing off to the right. Below the circle graphic, the word "MICRODENT" is written in a large, bold, sans-serif font, with the words "IMPLANT SYSTEM" written in a smaller font below it.

# 510(k) Summary

K242023

| DATE PREPARED: | 2025-02-10 |
|-------------------------|--------------------------------------------------------------------------------------|
| SUBMITTER NAME: | Implant Microdent Systems S.L.U. |
| SUBMITTER ADDRESS: | C/ Carles Buigas, 1 - Can Magre<br>08187, Sta Eulalia de Ronçana, Barcelona<br>SPAIN |
| CONTACT: | Marcela Gil |
| TELEPHONE: | [phone] |
| e-mail: | [e-mail] |
| DEVICE TRADE NAME: | Microdent Sterilization Cassette |
| COMMON NAME: | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| REGULATION DESCRIPTION: | Sterilization wrap |
| REGULATION NUMBER: | 21 CFR 880.6850 |
| PRODUCT CODE: | KCT |
| PREDICATE DEVICE(S): | PolyVac Inc (PolyVac Surgical Instrument Delivery System) (K012105) |

# DEVICE DESCRIPTION:

Microdent Sterilization Cassette consists of different sizes of the same basic configuration (maximum weight 509 gr). All systems consist of a minimum of a plastic base and cover. Each cover can be fastened to its corresponding base by means of locking tab or guides. Accessories may be used with systems to organize or separate contents to be placed in them for use.

The Delivery Systems are designed using plastic and metal materials that can be reused with steam sterilization methods. Each tray and cover have an evenly distributed hole pattern in relation to its size.

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Image /page/6/Picture/0 description: The image shows the logo for Microdent Implant System. The logo features the text "MICRODENT IMPLANT SYSTEM" in bold, black letters. Above the text is a graphic of overlapping circles with the letters "MD" inside the first circle. Below the text is the phrase "INDICATIONS FOR USE:" in bold, black letters.

Microdent Sterilization Cassette is intended to organize, and store various dental surgical drills and tools in order to organize and facilitate the sterilization process by allowing steam penetration and air removal.

When used in conjunction with FDA-cleared sterilization accessories (wrap, biological indicators, and chemical indicators) in an FDA-cleared sterilizer, sterility of the enclosed medical devices is maintained until used.

The sterilization cassette is intended for sterilization in a pre-vacuum steam sterilizer utilizing this recommended cycle:

- -Temperature: 270°F/132°C
- -Exposure time: 4 minutes.
- -Drying time: 20 minutes.
- -The cassettes are not to be stacked during sterilization.

KTF and KBE references represent the worst case validated load due to the total weight of 509 grams and 220 grams respectively.

Implant Microdent System S.L. does not make any lumen claims for the Microdent Sterilization Cassette.

The following list of sterilization cassette models are available and the corresponding instrument load weight that can be sterilized in each model is as listed.

| REFERENCE | WEIGHT | DIMENSIONS | VOLUME<br>TO VENT<br>RATIO |
|-----------|--------|----------------|----------------------------|
| KCIGN | 481g | 190x140x6.5mm | 3.38 mm<br>(0.133 inch) |
| KCIEK | 481g | 190x140x6.5mm | 3.38 mm<br>(0.133 inch) |
| KIO | 450g | 200X105X34mm | 27,737 mm<br>(1.092 inch) |
| KFM | 450g | 190x140x61.5mm | 3.38 mm<br>(0.133 inch) |
| KTF | 509g | 184x136x31mm | 131,98 mm<br>(5.196 inch) |
| KEO | 464g | 190x140x61.5mm | 3.38 mm<br>(0.133 inch) |
| KBE | 220g | 143x79x23mm | 24.36 mm<br>(0.959 inch) |
| KCF | 262g | 143x99.5x61mm | 3,302 mm<br>(0.130 inch) |

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Image /page/7/Picture/0 description: The image shows the logo for Microdent Implant System. The logo includes a stylized "MD" in a circle with curved lines emanating from it. Below the logo, the words "MICRODENT" and "IMPLANT SYSTEM" are written in a bold, sans-serif font. The text "SUMMARY OF COMPARISON WITH PREDICATE DEVICE:" is written in a smaller, sans-serif font below the words "IMPLANT SYSTEM".

In the establishment of a technology comparison, Microdent Sterilization Cassettes are compared with the following previously cleared devices:

| Summary of<br>comparison<br>with predicate<br>devices | Proposed Device<br>(K242023) | Predicate Device<br>(K012015) | Comments |
|---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| Appearance | Microdent Sterilization Cassette<br><br>Image: (KBE) | PolyVac Surgical<br>Instrument Delivery<br>System<br><br>Image: (Minitainer II) | Similar |
| Classification /<br>PROCODE | 880.6850 (KCT) | 880.6850 (KCT) | Same |
| Intended Use | Microdent Sterilization Cassette is<br>intended to organize, protect, and<br>store various dental surgical drills<br>and tools in order to organize and<br>facilitate the sterilization process<br>by allowing steam penetration and<br>air removal.<br>When used in conjunction with<br>FDA-cleared sterilization<br>accessories (wrap, biological<br>indicators, and chemical indicators)<br>in an FDA-cleared sterilizer,<br>sterility of the enclosed medical<br>devices is maintained until used.<br>The sterilization cassette is<br>intended for sterilization in a pre-<br>vacuum steam sterilizer utilizing<br>this recommended cycle:<br>Temperature: 270°F/132°C<br>Exposure time: 4 minutes.<br>Drying time: 20 minutes.<br>The cassettes are not to be<br>stacked during sterilization.<br>KTF and KBE references represent<br>the worst case/best case validated<br>load due to the total weight of 509<br>grams and 220 grams respectively.<br>Implant Microdent System S.L.<br>does not make any lumen claims<br>for the Microdent Sterilization<br>Cassette. | PolyVac's delivery<br>systems are intended to<br>protect medical device<br>instrumentation and to<br>facilitate the sterilization<br>process by allowing steam<br>penetration and air<br>removal. When used in<br>conjunction with an<br>approved sterilization<br>wrap, sterility of the<br>enclosed medical device<br>is maintained until used.<br>PolyVac's delivery<br>systems are to be<br>sterilized in one of the<br>following cycles:<br>Prevacuum Steam: 132°C<br>- 4 minutes minimum<br>Dry for 20 - 40 minutes as<br>needed<br>Gravity Steam: 132°C -<br>30 minutes minimum<br>Gravity Steam: 121°C -<br>55 minutes minimum<br>Dry for 20 - 50 minutes as<br>needed | Similar; the subject device<br>does not have a gravity steam<br>sterilization cycle claim. |
| Summary of<br>comparison | Proposed Device<br>(K242023) | Predicate Device<br>(K012105) | Comments |
| with predicate<br>devices | Microdent Sterilization<br>Cassette | PolyVac Surgical<br>Instrument Delivery<br>System | |
| Description | - Base, modular insert trays and<br>covers<br>- Evenly distributed<br>perforated hole pattern.<br>- Silicone mats | - Base, modular insert<br>trays and lids<br>- Evenly distributed<br>perforated hole<br>pattern.<br>- Silicone mats | Similar |
| Dimensions<br>(l x w x h) | Largest: 184 x 136 x 31 mm<br>Smallest: 43 x 79 x 23 mm. | 17.3 x 7.25 x 4 mm | Different |
| Maximum weight | 509 kg | Not stated in summary | N/A |
| Sterilant<br>Penetration (air<br>permeance /<br>perforations) | Evenly distributed hole pattern | Evenly distributed hole<br>pattern | Same |
| Microbial<br>Barrier<br>Properties | To be used in conjunction with an<br>FDA cleared sterilization wrap. | To be used in<br>conjunction with an FDA<br>cleared sterilization<br>wrap. | Same |
| Shelf Life | Reusable | Reusable | Same |
| Steam<br>Sterilization<br>Parameters | - Temperature: 270°F/132°C<br>- Exposure time: 4 minutes.<br>- Drying time: 20 minutes. | Prevacuum Steam:<br>132°C - 4 minutes<br>minimum.<br>Dry for 20-40 minutes as<br>needed<br>Gravity Steam: 132°C -<br>30 minutes minimum<br>Gravity Steam: 121°C -<br>55 minutes minimum<br>Dry for 20 - 50 minutes<br>as needed | Similar |

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Image /page/8/Picture/0 description: The image contains a logo for Microdent Implant System. The logo features the word "MICRODENT" in a bold, sans-serif font, with the words "IMPLANT SYSTEM" in a smaller font underneath. Above the word "MICRODENT" is a circular graphic with the letters "MD" inside, followed by a series of curved lines that resemble sound waves or ripples.

Microdent Sterilization Cassettes are similar in fundamental scientific technology to the predicate devices in that they all have been designed, manufactured, and tested in compliance with FDA'S Class II device (product code KCT).

Microdent Sterilization Cassettes are technologically similar in materials, intended use, packaging, labeling and performance to the predicate devices currently marketed in the U.S. The only differences the subject devices and the predicates are in design and dimensions.

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Image /page/9/Picture/0 description: The image contains a logo for a company called MICRODENT IMPLANT SYSTEM. The logo features the letters "MD" inside of a circle, with a series of curved lines extending to the right of the circle. The words "MICRODENT" are written in a bold, sans-serif font, and the words "IMPLANT SYSTEM" are written in a smaller, sans-serif font below the word "MICRODENT". The logo is simple and modern, and it is likely used to represent a dental implant company.

## SUMMARY DISCUSSION OF NON-CLINICAL DATA:

The proposed device has been subject to bench testing to determine conformance to performance specifications and requirements taking account of its intended use.

Non-clinical testing listed in the table below and performed in foreseeable operating conditions showed correct operation of the device as per its intended use.

| Summary of Non-Clinical Testing | | | | | |
|--------------------------------------------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|---------|--|
| Test Name | Test<br>Methodology | Purpose | Acceptance Criteria | Results | |
| Sterilization Cycle<br>Validation | ISO 17665-2:2009<br>ANSI/AAMI/ISO<br>17665-1:2006/<br>(R)2013<br>ANSI / AAMI<br>ST77:2013 | To validate that the trays<br>can be sterilized via moist-<br>heat sterilization as<br>specified on labeling (132°<br>C for 4 minutes) | Sterility assurance level<br>(SAL) of ≤ 10-6 | Pass | |
| Drying Validation | Internal Test Method | To validate that the trays<br>can be dried as specified<br>on labeling (drying time of<br>20 minutes) | No visible moisture | Pass | |
| Cleaning<br>(Manual<br>Pre- Cleaning and<br>Automated<br>Cleaning) | AAMI TIR30:2011 | To validate that the trays<br>can be cleaned as<br>specified on labeling | No visible soil.<br>Protein: < 6.4 µg/cm²<br>Hemoglobin: < 2.2 µg/cm² | Pass | |
| Reprocessing<br>of<br>Trays (cleaning and<br>sterilization) | Internal Test Method | To confirm that the trays<br>can be reprocessed as<br>specified on labeling (up to<br>100 reprocessing cycles<br>without any signs<br>of<br>abrasion) | No signs of flush rust,<br>rust, corrosion,<br>deformation or damage | Pass | |

### SUMMARY DISCUSSION OF CLINICAL DATA

Non-clinical test data are submitted to support this premarket notification. No clinical studies are submitted.

### CONCLUSIONS

The conclusions drawn from the non-clinical tests demonstrate that the proposed device, K242023, is as safe, as effective, and performs as well as or better than the predicate device, K012105.