LiteSet Trays

{0} FDA U.S. FOOD & DRUG ADMINISTRATION September 8, 2026 Nobel Biocare AB Bernice Jim Head of RA Implant Systems Vastra Hamngatan 1 Goteborg, Vastra SE 411 17 Sweden Re: K253988 Trade/Device Name: LiteSet Trays Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: September 8, 2026 Received: September 8, 2026 Dear Bernice Jim: 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" U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K253988 - Bernice Jim Page 2 (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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 (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-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-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). {2} K253988 - Bernice Jim Page 3 Sincerely, STEPHEN A. ANISKO -S Digitally signed by STEPHEN A. ANISKO -S Date: 2026.09.08 17:48:27 -04'00' Stephen Anisko, MS Assistant 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 {3} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. 510(k) Number (if known) K253988 Device Name LiteSet Trays Indications for Use (Describe) The LiteSet Trays are intended to organize, store, and sterilize instrumentation or components used for dental implant surgical and prosthetic procedures. The tray is to be enclosed in an FDA cleared steam sterilizable pouch or wrap and sterilized in an FDA cleared sterilizer for one of the following cycles: (1) Prevacuum Steam – At 132°C for 4 minutes with a 20 minutes dry time. (2) Gravity Steam – At 132°C for 15 minutes with a 20 minutes dry time. - The tray is intended for sterilization of non-porous loads. - Do not stack trays during sterilization. - Nobel Biocare does not make any lumen claims for the LiteSet Trays | Model # | Model Name | Max # of Instruments | Max Load (g) | Vent-to-Volume Ratio (in⁻¹) | | --- | --- | --- | --- | --- | | 302492 | NobelActive®/NobelParallel™ CC LiteSet™ Tray | 62 | 498.00 | 0.0314 | | 302494 | NobelReplace® CC LiteSet™ Tray | 51 | 437.00 | 0.0320 | | 302496 | Nobel Biocare N1™ LiteSet™ Tray | 23 | 294.00 | 0.0447 | | 302498 | Prosthetic LiteSet™ Tray | 21 | 318.00 | 0.0454 | | 302500 | Polo Multi-unit Abutment LiteSet™ Tray | 50 | 254.65 | 0.0453 | | 302503 | NobelSpeedy®/Brånemark/Replace Select™ TC LiteSet™ Tray | 47 | 462.00 | 0.0324 | | 302533 | NobelActive®/NobelParallel™ S LiteSet™ Tray | 51 | 488.00 | 0.0317 | | 302535 | NobelReplace® S LiteSet™ Tray | 43 | 432.00 | 0.0320 | | 302595 | Conical Connection Scan Body - Singles LiteSet™ Tray | 18 | 235.41 | 0.0448 | | 302596 | Conical Connection Scan Body - Bridge LiteSet™ Tray | 26 | 240.42 | 0.0446 | | 302597 | External hex Scan Body LiteSet™ Tray | 14 | 231.93 | 0.0447 | | 302598 | Tri-channel Scan Body LiteSet™ Tray | 18 | 238.97 | 0.0448 | | 302599 | Nobel Biocare N1™ system Scan Body LiteSet™ Tray | 18 | 220.38 | 0.0448 | | 302600 | On1™ base Scan Body LiteSet™ Tray | 14 | 233.02 | 0.0447 | 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. FORM FDA 3881 (8/23) Page 1 of 2 PSC Publishing Services (301) 443-6740 EF {4} This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." FORM FDA 3881 (8/23) Page 2 of 2 {5} Nobel Biocare™ # 1 510(k) Summary, K253988 In accordance with 21 CFR 807.92 ## 1.1 Submitter Information Submitter: Nobel Biocare AB Vastra Hamngatan 1 Goteborg 411 17 Sweden Contact Person: Bernice Jim, PhD Telephone Number: +41 43 211 42 00 E-Mail: regulatory.affairs.nb@envistaco.com Date Prepared September 4, 2026 Submitted By: Nobel Biocare Services AG Balz-Zimmerman-Strasse 7 8302 Kloten Switzerland Managed and prepared by: Ana Sala Roca, PhD ## 1.2 Device Name Proprietary name: LiteSet Trays Manufacturer: Nobel Biocare AB Common Name: Sterilization wrap Classification Name: Sterilization wrap containers, trays, cassettes & other accessories Regulation Number: 21 CFR 880.6850 Device Class: II Product Code: KCT Page 1 of 10 {6} Nobel Biocare™ ## 1.3 Predicate Device Predicate device | Proprietary name: | Standard Sterilizable Tray (K202524) | | --- | --- | | Manufacturer: | Implant Direct Sybron Manufacturing LLC | | Common Name: | Sterilization wrap | | Classification Name: | Sterilization wrap containers, trays, cassettes & other accessories | | Regulation Number: | 21 CFR 880.6850 | | Device Class: | II | | Product Code: | KCT | ## 1.4 Device Description The LiteSet Trays are a reusable perforated instrument cassette system designed to hold the respective Nobel Biocare's dental surgical and prosthetic instruments in place during transport, steam sterilization, and storage. The LiteSet Trays are composed of three main components: a lid (or cover), a base and a variable inner insert also referred to as plate, which are assembled into a single unit. All three components are made of polyphenylsulfone (PPSU). The insert (or plate) has silicone rubber that is co-molded in the plastic of the plate as well as co-molded silicone grommets. Each plate is silk screened to identify the location of each component (tool identifiers) and procedural information for the specific system as applicable. Since the LiteSet Trays are perforated, an FDA cleared wrap, or pouch must be used for sterilization purposes and to maintain the sterility of the content. The Subject Trays are designed to be used with standard autoclaves used in hospitals and healthcare facilities. Each LiteSet Tray is specifically designed to accommodate the instrumentation required for its corresponding dental implant or prosthetic system. Instruments are secured within the tray using dedicated holders - primarily star-shaped silicone retainers, stripe-shaped silicone retainers, and silicone blocks - and are arranged either across the plate or between the plate and the base. Page 2 of 10 {7} N Nobel Biocare™ ### 1.5 Indications for Use The LiteSet Trays are intended to organize, store, and sterilize instrumentation or components used for dental implant surgical and prosthetic procedures. The tray is to be enclosed in an FDA cleared steam sterilizable pouch or wrap and sterilized in an FDA cleared sterilizer for one of the following cycles: (1) Prevacuum Steam – At 132°C for 4 minutes with a 20 minutes dry time. (2) Gravity Steam – At 132°C for 15 minutes with a 20 minutes dry time. - The tray is intended for sterilization of non-porous loads. - Do not stack trays during sterilization. - Nobel Biocare does not make any lumen claims for the LiteSet Trays | Model # | Model Name | Max # of Instruments | Max Load (g) | Vent-to-Volume Ratio (in^{-1}) | | --- | --- | --- | --- | --- | | 302492 | NobelActive®/NobelParallel™ CC LiteSet™ Tray | 62 | 498.00 | 0.0314 | | 302494 | NobelReplace® CC LiteSet™ Tray | 51 | 437.00 | 0.0320 | | 302496 | Nobel Biocare N1™ LiteSet™ Tray | 23 | 294.00 | 0.0447 | | 302498 | Prosthetic LiteSet™ Tray | 21 | 318.00 | 0.0454 | | 302500 | Polo Multi-unit Abutment LiteSet™ Tray | 50 | 254.65 | 0.0453 | | 302503 | NobelSpeedy®/Brånemark/Replace Select™ TC LiteSet™ Tray | 47 | 462.00 | 0.0324 | | 302533 | NobelActive®/NobelParallel™ S LiteSet™ Tray | 51 | 488.00 | 0.0317 | | 302535 | NobelReplace® S LiteSet™ Tray | 43 | 432.00 | 0.0320 | | 302595 | Conical Connection Scan Body - Singles LiteSet™ Tray | 18 | 235.41 | 0.0448 | | 302596 | Conical Connection Scan Body - Bridge LiteSet™ Tray | 26 | 240.42 | 0.0446 | | 302597 | External hex Scan Body LiteSet™ Tray | 14 | 231.93 | 0.0447 | | 302598 | Tri-channel Scan Body LiteSet™ Tray | 18 | 238.97 | 0.0448 | | 302599 | Nobel Biocare N1™ system Scan Body LiteSet™ Tray | 18 | 220.38 | 0.0448 | | 302600 | On1™ base Scan Body LiteSet™ Tray | 14 | 233.02 | 0.0447 | Page 3 of 10 {8} N Nobel Biocare™ # 1.6 Technological Comparison | Technological characteristics | Subject Device LiteSet Trays, K253988 | Predicate Device Standard Sterilizable Tray, K202524 | Comparison | | --- | --- | --- | --- | | Manufacturer | Nobel Biocare | Implant Direct Sybron Manufacturing LLC | N/A | | Product classification | II | II | Same | | Regulation Number / Name | 21 CFR 880.6850 Sterilization wrap | 21 CFR 880.6850 Sterilization wrap | Same | | Product Code | KCT (sterilization wrap containers, trays, cassettes & other accessories) | KCT (sterilization wrap containers, trays, cassettes & other accessories) | Same | | Review Panel | General Hospital | General Hospital | Same | | Indications for Use | The LiteSet Trays are intended to organize, store, and sterilize instrumentation or components used for dental implant surgical and prosthetic procedures. The tray is to be enclosed in an FDA cleared steam sterilizable pouch or wrap and sterilized in an FDA cleared sterilizer for one of the following cycles: (1) Prevacuum Steam – At 132°C for 4 minutes with a 20 minutes dry time. (2) Gravity Steam – At 132°C for 15 minutes with a 20 minutes dry time. • The tray is intended for sterilization of non-porous loads. • Do not stack trays during sterilization. • Nobel Biocare does not make any lumen claims for the LiteSet Trays | The Standard Sterilizable Tray is designed to hold various dental surgical and prosthetic instruments in order to organize, steam sterilize, and transport the instruments between uses. The tray is to be enclosed in an FDA cleared steam sterilizable wrap (maximum thickness KC300) and sterilized in an FDA cleared sterilizer for one of the following cycles: (1) Prevacuum Steam – At 132°C for 4 minutes with a 20 minutes dry time. (2) Gravity Steam – At 132°C for 15 minutes with a 30 minutes dry time. • The tray is intended for sterilization of non-porous loads. • Do not stack trays during sterilization. • The tested Tray represents the worst case validated load of 667.52 grams. • Implant Direct Sybron Manufacturing LLC does not make any lumen claims for the Standard Sterilizable Tray. | Same with minor differences in choice of words. The subject device does not specify a maximum thickness for the wrap. Technical specifications for each tray models are specific to the individual model. Differences supported by cleaning and sterilization validation. | Page 4 of 10 {9} N Nobel Biocare™ | | | Model # | Model Name | Max # of Instruments | Max Load (g) | Vent to volume Ratio (m3) | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | 302492 | NobelActive®/NobelParallelTM CC LiteSetTM Tray | 62 | 496.00 | 0.0314 | | | | | | 302494 | NobelReplace® CC LiteSetTM Tray | 51 | 437.00 | 0.0320 | | | | | | 302496 | Nobel Biocare N1TM LiteSetTM Tray | 23 | 294.00 | 0.0447 | | | | | | 302498 | Prosthetic LiteSetTM Tray | 21 | 316.00 | 0.0454 | | | | | | 302500 | PoLo Multi-unit Abutment LiteSetTM Tray | 50 | 254.65 | 0.0453 | | | | | | 302503 | NobelSpeedy®/Bränemark/Replace SelectTM TC LiteSetTM Tray | 47 | 462.00 | 0.0324 | | | | | | 302533 | NobelActive®/NobelParallelTM S LiteSetTM Tray | 51 | 488.00 | 0.0317 | | | | | | 302535 | NobelReplace® S LiteSetTM Tray | 43 | 432.00 | 0.0320 | | | | | | 302595 | Conical Connection Scan Body Singles LiteSetTM Tray | 18 | 235.41 | 0.0448 | | | | | | 302596 | Conical Connection Scan Body Bridge LiteSetTM Tray | 26 | 240.42 | 0.0446 | | | | | | 302597 | External hex Scan Body LiteSetTM Tray | 14 | 231.93 | 0.0447 | | | | | | 302598 | Tri-channel Scan Body LiteSetTM Tray | 18 | 238.97 | 0.0448 | | | | | | 302599 | Nobel Biocare N1TM system Scan Body LiteSetTM Tray | 18 | 220.38 | 0.0448 | | | | | | 302600 | On1TM base Scan Body LiteSetTM Tray | 14 | 233.02 | 0.0447 | | | | General design | | Plastic tray with locking lid co-molded silicone and silicone grommet.Tray is composed of a lid, a base and a plate (or variable insert), assembled into a single unit. Instruments are secured in the tray using dedicated holders and are arranged either across the plate or between the plate and the base. | | | | Plastic tray with locking lid co-molded silicone and silicone grommets and stainless-steel component (pan).Tray is composed of a lid, a base and a plate (or variable insert), assembled into a single unit. Instruments are secured in the tray using dedicated holders and are arranged either across the plate or between the plate and the base. | Same | | | Dimensions | | Size S: 138mm x 98mm x 63mmSize M: 185mm x 139mm x 63mm | | | | Size M: 185mm X 139mm X 63mm(7.3 in x 5.5 in x 2.4 in) | Same | | | Materials | | Base – polyphenylsulfone (PPSU)Lid – polyphenylsulfone (PPSU)Inner tray – polyphenylsulfone (PPSU)Tooling support - Silicone | | | | Base – polyphenylsulfone (PPSU)Lid – polyphenylsulfone (PPSU)Inner tray – polyphenylsulfone (PPSU)Tooling support - SiliconePan – Stainless steel | Same | | | Air permeance | | Yes | | | | Yes | Same | | Page 5 of 10 {10} Nobel Biocare™ | **Maximum number of instruments (loaded)** | | **Model #** | **Max # of Instruments** | | **Model #** | **Max # of Instruments** | Similar Subject device accommodates a higher maximum number of instruments. Differences supported by cleaning and sterilization validation. | | --- | --- | --- | --- | --- | --- | --- | --- | | 302492 | 62 | CSSK | 46 | | 302494 | 51 | CISK | 34 | | 302496 | 23 | | | | 302498 | 21 | | | | 302500 | 50 | | | | 302503 | 47 | | | | 302533 | 51 | | | | 302535 | 43 | | | | 302595 | 18 | | | | 302596 | 26 | | | | 302597 | 14 | | | | 302598 | 18 | | | | 302599 | 18 | | | | 302600 | 14 | | | | **Mass of maximum sterilization load (loaded)** | | **Model #** | **Max Load (g)** | | **Model #** | **Max # of Instruments (g)** | Similar. The maximum sterilization load of the Subject Devices is lower than the one for the Predicate Device. Differences supported by cleaning and sterilization validation. | | 302492 | 498.00 | CSSK | 667.52 | | 302494 | 437.00 | CISK | 662.70 | | 302496 | 294.00 | | | | 302498 | 318.00 | | | | 302500 | 254.65 | | | | 302503 | 462.00 | | | | 302533 | 488.00 | | | | 302535 | 432.00 | | | | 302595 | 235.41 | | | | 302596 | 240.42 | | | | 302597 | 231.93 | | | | 302598 | 238.97 | | | | 302599 | 220.38 | | | | 302600 | 233.02 | | | Page 6 of 10 {11} N Nobel Biocare™ | Vent to volume ratio | | Model # | Vent to volume Ratio (in⁻¹) | | Model # | Vent to volume Ratio (in⁻¹) | Similar. The vent-to-volume ratio of the Subject Devices is higher than that of the predicate device. Differences supported by cleaning and sterilization validation. | | --- | --- | --- | --- | --- | --- | --- | --- | | 302492 | 0.0314 | CSSK | 0.021 | | 302494 | 0.0320 | CISK | 0.021 | | 302496 | 0.0447 | | | | 302498 | 0.0454 | | | | 302500 | 0.0453 | | | | 302503 | 0.0324 | | | | 302533 | 0.0317 | | | | 302535 | 0.0320 | | | | 302595 | 0.0448 | | | | 302596 | 0.0446 | | | | 302597 | 0.0447 | | | | 302598 | 0.0448 | | | | 302599 | 0.0448 | | | | 302600 | 0.0447 | | | | Sterility | Non-sterile | Non-sterile | Same | | Sterilization method | Moist heat gravity or pre vacuum | Moist heat gravity or pre vacuum | Same | | Reusable | Yes | Yes | Same | | Biocompatibility | ISO 10993-1 | ISO 10993-1 | Same | | Sterilization Validation | ISO 17665-1 | ISO 17665-1 | Same | Page 7 of 10 {12} N Nobel Biocare™ The similarities between the Subject device LiteSet Trays and the Predicate Device are as follows: - The Intended Use and Indications for Use of the Subject LiteSet Trays and the Predicate Device are the same, though described with minor wording differences. Both are perforated instrument cassette systems designed to organize, store, and sterilize instrumentation or components for dental implant surgical and prosthetic procedures. They are validated for gravity-displacement and pre-vacuum sterilization cycles, with the only difference being a shorter drying time for the Subject Devices in the gravity steam cycle. Both require sterilization wrap during processing. - The Subject and Predicate Devices share the same general design: perforated trays composed of a locking lid, base, and plate (or variable insert), with instruments secured by dedicated holders. Both are made from PPSU and silicone, though the Subject Devices do not include stainless-steel components. Subject Devices are available in sizes S or M, while the Predicate Device is offered in size M; both are manufactured by the same contract manufacturer using the same processes and packaging. The Subject Devices have a lower maximum sterilization load but can accommodate more instruments and have a higher vent-to-volume ratio. - Both devices are provided non-sterile, are reusable, and have the same packaging configuration. They have been validated for biocompatibility and cleaning and sterilization (SAL of 10⁻⁶). Details of the Differences Between the Subject and Predicate Device: There are no significant differences between the Subject and Predicate Devices but there are minor differences as follows: - Subject trays differ slightly in wording for Indications for Use. They are validated for use with pouch and wrap, using a gravity steam cycle with a 20-minute drying time (vs. 30 minutes for the predicate). Maximum wrap thickness is not specified. Model-specific technical specifications apply. Differences are supported by cleaning and sterilization validation. - Overall tray design remains consistent, but each model is tailored for specific implant or prosthetic systems. Variations include layout, surface area, hidden surfaces, load weight, instrument type/quantity, and vent-to-volume ratio. These differences are supported by biocompatibility and sterilization validation. No new scientific technology is introduced, and design differences do not raise new safety or effectiveness concerns. Page 8 of 10 {13} N Nobel Biocare™ ### 1.7 Non-Clinical Testing The Subject Devices are reusable, non-sterile medical devices designed to store and organize Nobel Biocare surgical and prosthetic instruments and components during sterilization and implant/prosthetic treatment. Prior to use, the devices require end-user cleaning and sterilization. **Non-clinical testing data:** Cleaning and sterilization processes have been assessed and validated in accordance with “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling” (FDA, March 17, 2015). Cleaning and Sterilization Validation: - Manual and automated cleaning methods were successfully validated per AAMI TIR 12 and AAMI ST98. Simulated-use cycle was performed in accordance with AAMI ST98. Repeated soiling, cleaning and sterilization in accordance with AAMI ST98 was performed. The study used clinically relevant, simulated soil, extended drying time between soiling and processing, and minimal processing parameters for the cleaning process. Extracts of proposed devices were analyzed for total organic carbon (TOC) and protein as residual soil markers. - Sterilization validation was performed using the overkill method as described in ISO 17665-1. A sterility assurance level (SAL) of 10⁻⁶ was demonstrated for both steam sterilization cycles: gravity-displacement and pre-vacuum. In addition to the SAL validation, dry time was validated. Biocompatibility: LiteSet Trays are categorized as non-contacting devices with neither direct, nor indirect contact with the body, as defined in clause 3.16 of the ISO 10993-1. Cytotoxicity testing (ISO 10993-5) was performed to mitigate the potential risk of transferring residues from the subject device and contaminating the contained instruments during the intended storage or sterilization. A non-clinical testing summary is provided in the table below including acceptance criteria and results. Page 9 of 10 {14} N Nobel Biocare™ | Test | Test Method /Standards | Acceptance Criteria | Results | | --- | --- | --- | --- | | Manual and Automated Cleaning Validation | Simulated clinical soil contamination; manual & automated (including pre-cleaning) cleaning cycles. (AAMI ST98, AAMI TIR12) | - No soil visible on the sample at the end of the cleaning process. - Amount of protein/cm² < 6.4 µg/cm² - TOC/cm² < 6.0 µg/cm². - The sum of the maximum value and the standard deviation detected for the analyte under consideration shall be lower than the acceptance criterion | Pass | | Sterilization Validation and dry time validation | Steam sterilization gravity-displacement and pre-vacuum cycles (worst-case load) / overkill method per 17665-1. Dry time validated using full cycle parameters. (ISO 17665-1, AAMI TIR 12, AAMI ST79) | Sterility Assurance Level (SAL) of 10⁻⁶ achieved (no growth of the test organism Geobacillus stearothermophilus) Dry time evaluation: no mass gain over 1% for the sterile barrier. No mass gain of devices over 0.2%. | Pass | | Simulated use validation | Simulated-use cycle was performed in accordance with AAMI ST98. Repeated soiling, cleaning and sterilization in accordance with AAMI ST98 was performed. | Internal visual and functional acceptance criteria must be met. No visible soil residues following validated cleaning procedures. Devices remained capable of meeting all cleaning and reprocessing validation acceptance criteria following simulated-use conditions. | Pass | | Biocompatibility | In vitro cytotoxicity assay (ISO 10993-5) performed to address the potential risk of transferring residues from the LiteSet Tray components to the contained instruments during the intended storage, or sterilization. (ISO 10993-1, ISO 10993-5, ISO 10993-12) | No cytotoxic response; chemical residues within safe limits (≥70% cell viability) | Pass | # Clinical data: Clinical data is not required for the Subject Devices. ### 1.8 Conclusion: The conclusions drawn from the nonclinical tests demonstrate that the subject device, LiteSet Trays, are as safe, as effective, and performs as well as or better than the legally marketed predicate device, K202524. Page 10 of 10