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.

Device Description

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).

AI/ML Overview

The provided text describes the acceptance criteria and the results of the study conducted to demonstrate the safety and effectiveness of the Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Type of Testing	Test Purpose	Acceptance Criteria	Reported Device Performance
Manual Cleaning Validation (ANSI/AAMI ST98:2022)	Evaluate and validate the manual cleaning of the subject device	Visual Inspection: No visible soilHemoglobin Test: <2.2 µg/cm²Protein Test: <6.4 µg/cm²	Pass
Sterilization Validation (ANSI/AAMI/ISO 17665-1:2006/(R)2013)	Validate sterilization cycle and drying time of the subject devices	SAL ≤10-6 using the biological indicator (BI) overkill method	Pass
Reprocessing of Medical Devices in a Health Care Setting	Life Cycle (simulated use) testing after 100 cleaning and sterilization cycles	Test samples must withstand 100 cycles of use (cleaning, sterilization, and functional tests) without physical damage and compromising function.	Pass
Biocompatibility (ISO 10993-1:2018)	Chemical Characterization and Cytotoxicity	Cellular vitality for the extract of the sample >70%, which is considered non-cytotoxic.	Pass
Packaging Validation (ASTM D4169-23e1)	Packaging performance testing	Packaging must withstand the distribution environment	Pass

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

The document does not explicitly state the specific "sample size" in terms of number of individual units tested for each non-clinical test. However, it indicates:

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.
Data Provenance: The study is reported as non-clinical testing conducted by the manufacturer, Prismatik Dentalcraft, Inc. The document doesn't specify the country of origin of the data, but it refers to international standards (e.g., ANSI/AAMI, ISO, ASTM). The nature of these tests suggests they are prospective in that they are performed specifically to validate the device's performance against predefined criteria.

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

This information is not applicable and not provided in the document. The tests performed are non-clinical, objective evaluations against established scientific and engineering standards (e.g., visual inspection for soil, chemical tests for residue, biological indicators for sterility, mechanical testing for durability). They do not involve human interpretation of medical images or expert consensus to establish a "ground truth" in the way a diagnostic AI device would.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document for the reasons stated above. Adjudication typically applies to studies where human interpretation or consensus is required to determine a reference standard.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable and not provided in the document. The device in question is an "Autoclavable Cassette" (sterilization wrap accessory), not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is irrelevant to this device type.

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

This information is not applicable and not provided in the document. The device is a physical medical device (sterilization cassette), not an algorithm or software. Therefore, the concept of "standalone algorithm performance" is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical tests is based on objective, measurable standards and criteria established by recognized regulatory and industry standards (e.g., SAL ≤10^-6 for sterility, specific chemical residue limits for cleaning, visual inspection for damage, cellular vitality percentages for biocompatibility). These are not based on expert consensus, pathology, or outcomes data in the usual sense of diagnostic or therapeutic devices.

8. The Sample Size for the Training Set

This information is not applicable and not provided in the document. The device is a physical product and does not involve AI/machine learning, thus there is no "training set."

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

This information is not applicable and not provided in the document, as there is no training set for this type of device.

Summary

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

Sterilization parameters:

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

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: Haiyan.Wei@glidewelldental.com

Phone: 949-399-1984

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

Email: So.Park(@glidewelldental.com

Phone: 949-863-5479

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.

DeviceModel Name	CassetteSize	Max No. ofInstruments	Weight oftray empty(g)	Weight oftray full(g)	Vent toVolumeRatio
GlidewellHT™ ImplantGuidedSurgical Kit	212mm x173mm x64mm	63	484	641	$3.11 X10^{-3}$(mm-1)0.079 (in-1)
GlidewellHT™ ImplantSurgical Kit	199mm x174mm x60mm	52	407	476	$6.09 X10^{-4}$(mm-1)0.016 (in-1)
Glidewell™Prosthetic Kit	96mm x74mm x60mm	11	163	192	$8.50 X10^{-4}$(mm-1)0.022 (in-1)

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

V. Indications for Use

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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(K242564)	Predicate Device(K180791)	Comparison
Device Name	Autoclavable Cassette (Glidewell HTTTM ImplantGuided Surgical Kit, Glidewell HTTTM ImplantSurgical Kit, GlidewellTM Prosthetic Kit)	Straumann® BLX SurgicalCassette	N/A
Manufacturer	Prismatik Dentalcraft, Inc.	Straumann USA, LLC	N/A
Regulatory Classification
RegulationNumber	21 CFR 880.6850	21 CFR 880.6850	Same
ClassificationName	Sterilization Wrap	Sterilization Wrap	Same
Classification	II	II	Same
Product Code	KCT	KCT	Same
Intended Use/Indication For Use
Intended Use/Indications forUse	The Autoclavable Cassettes areused in healthcare facilities toorganize surgical and prostheticinstruments during sterilization,storage, and transport duringand after surgical uses. TheAutoclavable Cassettes are notintended to maintain sterility;they are intended to be used inconjunction with a legallymarketed, validated sterilizationwrap to maintain the sterility ofthe enclosed devices.Sterilization parameters:Pre-vacuum steam: 132°C(270° F) for 4 minutes with 30minutes drying time.Sterilization validations for theworst-case AutoclavableCassette included cassette andinstruments. The AutoclavableCassettes were validated for amaximum load of 641 grams forGlidewell HTTM Implant	The Straumann® BLX Cassetteis used in healthcare facilities toorganize, enclose, cleaning,sterilize, transport, and storemedical devices betweensurgical uses. The BLXCassette is not intended tomaintain sterility; it is intendedto be used in conjunction with alegally marketed, validatedsterilization wrap.The BLX Cassette has beenvalidated for a maximum loadof 300 grams, including cassetteand instruments.Sterilization parameters: Pre-vacuum steam: 132°C (270° F)for 4 minutes with 20 minutesdrying time.	Same; exceptfor minordifferences inthe devicetrade name,and devicesize/weight.
Characteristics	Subject Device(K242564)	Predicate Device(K180791)	Comparison
Technological Characteristics
	Guided Surgical Kit, 476 gramsfor Glidewell HT™ ImplantSurgical Kit, and 192 grams forGlidewell™ Prosthetic Kit.
Design	Plastic tray and lid	Plastic tray and lid	Same
Material	Polyphenylsulfone (Radel5000)SiliconStainless steel (lid hinge pin formedium size only)	Polyphenylsulfone (Radel5000)Silicon	Same; exceptfor the mediumsize of thesubject device,which has a lidhinge pin madeof stainlesssteel.
MaterialCompatible withSterilizationMethod	Yes	Yes	Same
Perforated	Yes; Allow moist heat (steam)penetration to achievesterilization.	Yes; Allow moist heat (steam)penetration to achievesterilization.	Same
Enclosed Feature	Silicone grommets	Silicone grommets	Same
Reusable	Yes, up to 100x	Yes, up to 100x	Same
SterilizationMethod	Moist heat (steam)	Moist heat (steam)	Same
Cycles	Pre-vacuum	Pre-vacuum	Same
Parameters	Pre-vacuum:132°C (270° F) for 4 minuteswith 30 minutes drying time.	Pre-vacuum:132°C (270° F) for 4 minuteswith 20 minutes drying time.	Similar; moredrying timerequired for thesubject device.
Sterile barrier	FDA cleared sterilization pouch	FDA cleared sterilization pouch	Same
Biocompatibility	The biocompatibilityassessment was performed perISO 10993-1 and testing wasperformed using methodsdescribed in ISO 10993-5. Theresults indicate the subjectdevices are non-cytotoxic.	The biocompatibilityassessment was performed perISO 10993-1 and testing wasperformed using methodsdescribed in ISO 10993-5. Theresults indicate the subjectdevices 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 CleaningValidation(ANSI/AAMIST98:2022)	Evaluate and validatethe manual cleaning ofthe subject device	Visual Inspection: Novisible soilHemoglobin Test: <2.2$\mu$ g/cm²Protein Test: <6.4$\mu$ g/cm²	Pass
SterilizationValidation(ANSI/AAMI/ISO17665-1:2006/(R)2013)	Validate sterilizationcycle and drying time ofthe subject devices	SAL ≤10-6 using thebiological indicator(BI) overkill method	Pass
Reprocessing ofMedical Devices in aHealth Care Setting	Life Cycle (simulateduse) testing after 100cleaning andsterilization cycles	Test samples mustwithstand 100 cycles of use(cleaning,sterilization, and functionaltests) without physicaldamage and compromisingfunction.	Pass
Biocompatibility(ISO 10993-1:2018)	ChemicalCharacterization andCytotoxicity	Cellular vitality for theextract of the sample>70%, which is considerednon-cytotoxic.	Pass
Packaging Validation(ASTM D4169-23e1)	Packaging performancetesting	Packaging must withstandthe distributionenvironment	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.

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).