Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit)

K242564 · Prismatik Dentalcraft, Inc. · KCT · Mar 21, 2025 · General Hospital

Device Facts

• Record ID: K242564
• Device Name: Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit)
• Applicant: Prismatik Dentalcraft, Inc.
• Product Code: KCT · General Hospital
• Decision Date: Mar 21, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The Autoclavable Cassettes are used in healthcare facilities to organize surgical and prosthetic instruments during sterilization, storage, and transport during and after surgical uses. The Autoclavable Cassettes are not intended to maintain sterility; they are intended to be used in conjunction with a legally marketed, validated sterilization wrap to maintain the sterility of the enclosed devices.

Device Story

Autoclavable Cassettes store, organize, and protect surgical and prosthetic instruments during sterilization, storage, and transport. Device consists of a PPSU lid, base, and tray with silicone rubber grommets to secure instruments. Perforated design allows moist heat penetration during steam sterilization. Healthcare providers place instruments into the cassette, secure the lid, and wrap the unit in an FDA-cleared sterilization wrap. The cassette is then processed via pre-vacuum steam sterilization (132°C for 4 minutes, 30 minutes drying). The device facilitates instrument positioning and organization during surgical procedures. Benefits include organized instrument management and protection of instruments during the sterilization cycle and subsequent storage.

Clinical Evidence

Bench testing only. Validations performed per ANSI/AAMI ST98:2022 (manual cleaning), ANSI/AAMI/ISO 17665-1:2006 (sterilization/drying time), and ISO 10993-1:2018 (biocompatibility). Simulated use testing confirmed device integrity over 100 cleaning/sterilization cycles. Packaging validated per ASTM D4169-23e1. All tests passed.

Technological Characteristics

Materials: Polyphenylsulfone (PPSU), silicone rubber, stainless steel (hinge pin). Design: Perforated plastic tray/lid with silicone grommets. Sterilization: Pre-vacuum steam (132°C, 4 min, 30 min dry). Reusable up to 100 cycles. Biocompatibility: ISO 10993-1/5 compliant (non-cytotoxic).

Indications for Use

Indicated for use in healthcare facilities to organize surgical and prosthetic instruments during sterilization, storage, and transport. Intended for use with a validated sterilization wrap to maintain sterility of enclosed devices.

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

• Straumann® BLX Surgical Cassette (K180791)

Submission Summary (Full Text)

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March 21, 2025

Prismatik Dentalcraft, Inc. Haiyan Wei Principal Regulatory Affairs Specialist 2144 Michelson Drive Irvine, California 92612

Re: K242564

Trade/Device Name: Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HTTM Implant Surgical Kit, Glidewell™ Prosthetic Kit) Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: February 18, 2025 Received: February 18, 2025

Dear Haiyan Wei:

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.

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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" (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 QS 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 Rule"). 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-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-regulatory

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assistance/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,

Stephen A. Digitally signed by
Stephen A. Anisko -S
Anisko -S Date: 2025.03.21
14:49:15 -04'00'

for: Christopher K. Dugard, M.S. 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) K242564

### Device Name

Autoclavable Cassette (Glidewell HTM Implant Guidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit)

### Indications for Use (Describe)

The Autoclavable Cassettes are used in healthcare facilities to organize surgical and prosthetic instruments during sterilization, storage, and transport during and after surgical uses. The Autoclavable Cassettes are not intended to maintain sterility; they are intended to be used in conjunction with a legally marketed, validated sterilization wrap to maintain the sterility of the enclosed devices.

Sterilization parameters:

Pre-vacuum steam: 132°C (270°F) for 4 minutes with 30 minutes drying time.

Sterilization validations for the worst-case Autoclavable Cassette and instruments. The Autoclavable Cassettes are validated for a maximum load of 641 grams for Glided Surgical Kit, 476 grams for Glidewell HTTM Implant Surgical Kit. and 192 grams for Glidewell™ Prosthetic Kit.

| 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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Image /page/4/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. On the left side of the logo is a triangle with a color gradient that starts with pink at the top, transitions to blue in the middle, and ends with yellow at the bottom. To the right of the triangle is the company name, "PRISMATIK DENTALCRAFT, INC.", written in a blue sans-serif font.

## 510(k) Summary K242564

## Submission Date: February 18, 2025

#### I. Contact Details

Applicant Name: Prismatik Dentalcraft, Inc.

Address: 2144 Michelson Drive, Irvine, CA 92612 United States

Applicant Contact: Ms. Haiyan Wei, Principal Regulatory Affairs Specialist

Email: [e-mail]

Phone: [phone]

Secondary Contact: Ms. So Hyun Park, Regulatory Affairs Manager

Email: So.Park(@glidewelldental.com

Phone: [phone]

#### II. Device Name

Device Trade Name: Autoclavable Cassette (Glidewell HTTM Implant Guided Surgical

Kit, Glidewell HTTM Implant Surgical Kit, Glidewell™ Prosthetic Kit)

Common Name: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Classification Name: Sterilization Wrap

Regulation Number: 21 CFR 880.6850

Regulatory Class: Class II

Product Code: KCT

#### III. Predicate Device

Predicate 510(k) #: K180791

Predicate Trade Name: Straumann® BLX Surgical Cassette

Classification Name: Sterilization Wrap

Regulation Number: 21 CFR 880.6850

Regulatory Class: Class II

Product Code: KCT

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Image /page/5/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a colorful triangle on the left and the company name on the right. The triangle is divided into several sections, each with a different color. The company name is written in blue, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line.

#### Device Description IV.

The Autoclavable Cassettes are designed to store, organize, and protect various surgical and prosthetic instruments that are sterilized by the healthcare provider. The Autoclavable Cassettes are composed of three main components: a lid, a base, and a tray. The components are made of polyphenylsulfone PPSU. The tray has silicone rubber grommets to hold the instruments in place. The lid latches to the base holds the tray, and all three components are designed to secure the kit into a single unit. The cassette protects the interior components during sterilization and subsequent storage. The kits are perforated to allow for penetration of moist heat during steam sterilization and require the use of an FDA-cleared sterilization wrap to maintain sterility. To facilitate the surgical procedure and the correct use and the positioning of the instrument, the tray has instrument descriptions on the surface.

Surgical and prosthetic instruments of the Glidewell Implant System are intended to be placed in the Autoclavable Cassette. These surgical and prosthetic instruments which are the contents of the sterilization cassette are all Class 1 exempt as described in 21 CFR 872.3980 (Endosseous dental implant accessories).

| Device<br>Model Name | Cassette<br>Size | Max No. of<br>Instruments | Weight of<br>tray empty<br>(g) | Weight of<br>tray full<br>(g) | Vent to<br>Volume<br>Ratio |
|----------------------------------------------------|----------------------------|---------------------------|--------------------------------|-------------------------------|-------------------------------------------|
| Glidewell<br>HT™ Implant<br>Guided<br>Surgical Kit | 212mm x<br>173mm x<br>64mm | 63 | 484 | 641 | $3.11 X10^{-3}$<br>(mm-1)<br>0.079 (in-1) |
| Glidewell<br>HT™ Implant<br>Surgical Kit | 199mm x<br>174mm x<br>60mm | 52 | 407 | 476 | $6.09 X10^{-4}$<br>(mm-1)<br>0.016 (in-1) |
| Glidewell™<br>Prosthetic Kit | 96mm x<br>74mm x<br>60mm | 11 | 163 | 192 | $8.50 X10^{-4}$<br>(mm-1)<br>0.022 (in-1) |

The Autoclavable Cassettes will be marketed in the following variations with accompanied instruments:

#### V. Indications for Use

The Autoclavable Cassettes are used in healthcare facilities to organize surgical and prosthetic instruments during sterilization, storage, and transport during and after surgical uses. The Autoclavable Cassettes are not intended to maintain sterility; they are intended

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Image /page/6/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangle with a colorful, prismatic design. To the right of the triangle is the company name, "PRISMATIK DENTALCRAFT, INC." in blue text.

to be used in conjunction with a legally marketed, validated sterilization wrap to maintain the sterility of the enclosed devices.

Sterilization parameters:

Pre-vacuum steam: 132°C (270° F) for 4 minutes with 30 minutes drying time.

Sterilization validations for the worst-case Autoclavable Cassette included cassette and instruments. The Autoclavable Cassettes were validated for a maximum load of 641 grams for Glidewell HTM Implant Guided Surgical Kit, 476 grams for Glidewell HTTM Implant Surgical Kit, and 192 grams for Glidewell™ Prosthetic Kit.

#### VI. Technological Comparison

The subject device and predicate device share the following characteristics:

- Same intended use ●
- . Same design
- Same principal of operation .
- Same sterilization method
- Reusable ●

The subject device is technologically different from the predicate device as follows:

- Materials (same materials except medium size cassette which has a lid hinge pin ● made of stainless steel)
- Cassette size/weight ●
- Vent-to-Volume ratio .
- . Drying time

The technological characteristics of the subject device are compared to the predicate device in Table 1 below. Any noted differences in the technological characteristics between the subject device and the predicate device do not raise new concerns of safety and effectiveness.

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Image /page/7/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a triangle on the left side, which is divided into several sections with different colors. To the right of the triangle is the text "PRISMATIK DENTALCRAFT, INC." The text is in a sans-serif font and is blue.

| Characteristics | Subject Device<br>(K242564) | Predicate Device<br>(K180791) | Comparison |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Autoclavable Cassette (Glidewell HTTTM Implant<br>Guided Surgical Kit, Glidewell HTTTM Implant<br>Surgical Kit, GlidewellTM Prosthetic Kit) | Straumann® BLX Surgical<br>Cassette | N/A |
| Manufacturer | Prismatik Dentalcraft, Inc. | Straumann USA, LLC | N/A |
| Regulatory Classification | | | |
| Regulation<br>Number | 21 CFR 880.6850 | 21 CFR 880.6850 | Same |
| Classification<br>Name | Sterilization Wrap | Sterilization Wrap | Same |
| Classification | II | II | Same |
| Product Code | KCT | KCT | Same |
| Intended Use/Indication For Use | | | |
| Intended Use/<br>Indications for<br>Use | The Autoclavable Cassettes are<br>used in healthcare facilities to<br>organize surgical and prosthetic<br>instruments during sterilization,<br>storage, and transport during<br>and after surgical uses. The<br>Autoclavable Cassettes are not<br>intended to maintain sterility;<br>they are intended to be used in<br>conjunction with a legally<br>marketed, validated sterilization<br>wrap to maintain the sterility of<br>the enclosed devices.<br><br>Sterilization parameters:<br>Pre-vacuum steam: 132°C<br>(270° F) for 4 minutes with 30<br>minutes drying time.<br><br>Sterilization validations for the<br>worst-case Autoclavable<br>Cassette included cassette and<br>instruments. The Autoclavable<br>Cassettes were validated for a<br>maximum load of 641 grams for<br>Glidewell HTTM Implant | The Straumann® BLX Cassette<br>is used in healthcare facilities to<br>organize, enclose, cleaning,<br>sterilize, transport, and store<br>medical devices between<br>surgical uses. The BLX<br>Cassette is not intended to<br>maintain sterility; it is intended<br>to be used in conjunction with a<br>legally marketed, validated<br>sterilization wrap.<br><br>The BLX Cassette has been<br>validated for a maximum load<br>of 300 grams, including cassette<br>and instruments.<br><br>Sterilization parameters: Pre-<br>vacuum steam: 132°C (270° F)<br>for 4 minutes with 20 minutes<br>drying time. | Same; except<br>for minor<br>differences in<br>the device<br>trade name,<br>and device<br>size/weight. |
| Characteristics | Subject Device<br>(K242564) | Predicate Device<br>(K180791) | Comparison |
| Technological Characteristics | | | |
| | Guided Surgical Kit, 476 grams<br>for Glidewell HT™ Implant<br>Surgical Kit, and 192 grams for<br>Glidewell™ Prosthetic Kit. | | |
| Design | Plastic tray and lid | Plastic tray and lid | Same |
| Material | Polyphenylsulfone (Radel<br>5000)<br>Silicon<br>Stainless steel (lid hinge pin for<br>medium size only) | Polyphenylsulfone (Radel<br>5000)<br>Silicon | Same; except<br>for the medium<br>size of the<br>subject device,<br>which has a lid<br>hinge pin made<br>of stainless<br>steel. |
| Material<br>Compatible with<br>Sterilization<br>Method | Yes | Yes | Same |
| Perforated | Yes; Allow moist heat (steam)<br>penetration to achieve<br>sterilization. | Yes; Allow moist heat (steam)<br>penetration to achieve<br>sterilization. | Same |
| Enclosed Feature | Silicone grommets | Silicone grommets | Same |
| Reusable | Yes, up to 100x | Yes, up to 100x | Same |
| Sterilization<br>Method | Moist heat (steam) | Moist heat (steam) | Same |
| Cycles | Pre-vacuum | Pre-vacuum | Same |
| Parameters | Pre-vacuum:<br>132°C (270° F) for 4 minutes<br>with 30 minutes drying time. | Pre-vacuum:<br>132°C (270° F) for 4 minutes<br>with 20 minutes drying time. | Similar; more<br>drying time<br>required for the<br>subject device. |
| Sterile barrier | FDA cleared sterilization pouch | FDA cleared sterilization pouch | Same |
| Biocompatibility | The biocompatibility<br>assessment was performed per<br>ISO 10993-1 and testing was<br>performed using methods<br>described in ISO 10993-5. The<br>results indicate the subject<br>devices are non-cytotoxic. | The biocompatibility<br>assessment was performed per<br>ISO 10993-1 and testing was<br>performed using methods<br>described in ISO 10993-5. The<br>results indicate the subject<br>devices are non-cytotoxic. | Same |

# Table 1: Comparison Table Between Subject Device and Predicate Device

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Image /page/8/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. The logo consists of a colorful triangle on the left and the company name on the right. The triangle is divided into sections of different colors, including pink, red, yellow, green, and blue. The company name is written in blue, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line.

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Image /page/9/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangle with a color wheel design. To the right of the triangle is the company name in blue text. The words "PRISMATIK" and "DENTALCRAFT, INC." are stacked on top of each other.

#### Summary of Non-Clinical Testing VII.

The performance during multiple reprocessing steps for Autoclavable Cassette, recommended in the labeling, was validated according to applicable as recommendations in the FDA guidance document - Guidance for Industry and Food and Drug Administration Staff: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015. The worst-case cassettes were tested for performance based on critical impact factors including weight, vent to volume ratio, and worst-case instruments to be contained. The summary of performance testing is provided in Table 2 below.

| Type of Testing | Test Purpose | Acceptance Criteria | Test Result |
|----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Manual Cleaning<br>Validation<br>(ANSI/AAMI<br>ST98:2022) | Evaluate and validate<br>the manual cleaning of<br>the subject device | Visual Inspection: No<br>visible soil<br>Hemoglobin Test: <2.2<br>$\mu$ g/cm²<br>Protein Test: <6.4<br>$\mu$ g/cm² | Pass |
| Sterilization<br>Validation<br>(ANSI/AAMI/ISO<br>17665-1:2006/<br>(R)2013) | Validate sterilization<br>cycle and drying time of<br>the subject devices | SAL ≤10-6 using the<br>biological indicator<br>(BI) overkill method | Pass |
| Reprocessing of<br>Medical Devices in a<br>Health Care Setting | Life Cycle (simulated<br>use) testing after 100<br>cleaning and<br>sterilization cycles | Test samples must<br>withstand 100 cycles of use<br>(cleaning,<br>sterilization, and functional<br>tests) without physical<br>damage and compromising<br>function. | Pass |
| Biocompatibility<br>(ISO 10993-1:2018) | Chemical<br>Characterization and<br>Cytotoxicity | Cellular vitality for the<br>extract of the sample<br>>70%, which is considered<br>non-cytotoxic. | Pass |
| Packaging Validation<br>(ASTM D4169-23e1) | Packaging performance<br>testing | Packaging must withstand<br>the distribution<br>environment | Pass |

Table 2. Performance Testing Summary

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Image /page/10/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a colorful triangle on the left and the company name on the right. The triangle is divided into sections of different colors, including pink, blue, and yellow. The company name is written in blue, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line.

#### VIII. Conclusion

Based on the intended use, technological characteristics, and non-clinical performance data, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device, cleared under K180791, Class II (21 CFR 880.6850), product code KCT.