(255 days)
The Stainless Steel Surgical Kits are intended for organizing, sterilizing and storing of drills, instruments, and prosthetic accessories.
The Stainless Steel Surgical Kits are not intended to maintain sterility and are to be used in conjunction with a legally marketed, validated sterilization pouch.
Sterilization parameters
- Pre-vacuum Steam at 132 °C (270 °F) for 4 minutes with a 20 minute dry time.
- Do not exceed the worst-case validated maximum load:
| Item Number | Product Name | Dimensions (inch) | Max Load (gr) | Vent to Volume Ratio (inch-1) | Kit type |
|---|---|---|---|---|---|
| MK-0020 | Bone compression kit | 3.94x3.46x1.86 | 318.77 | 0.15 | Closed |
| MK-0056 | Scan post Int. Hexagon connection Kit | 2.60x2.83x1.02 | 143.59 | 0.29 | Closed |
| MK-0057 | Scan post Conical connection Kit | 2.60x2.83x1.02 | 146.32 | 0.29 | Closed |
| MK-0059 | Bone profiler Int. Hex. kit | 2.79x1.18x1.77 | 79.26 | 10.18 | Open |
| MK-0060 | Bone profiler coni. con. kit | 2.79x1.18x1.77 | 81.00 | 10.18 | Open |
| MK-0065 | Scan post organizer box | 2.60x2.83x1.02 | 146.32 | 0.29 | Closed |
| MK-BC101 | Drill stopper kit for C1 implant, SP | 2.60x2.83x1.02 | 144.87 | 0.29 | Closed |
| MK-BS001 | Drill stopper kit for Seven implant, SP | 2.60x2.83x1.02 | 144.64 | 0.29 | Closed |
| MK-CDS08 | Drill stopper kit for 8mm length C1 implant procedure | 1.97x2.83x1.02 | 117.27 | 0.26 | Closed |
| MK-CDS10 | Drill stopper kit for 10mm length C1 implant procedure | 1.97x2.83x1.02 | 116.70 | 0.26 | Closed |
| MK-CDS11 | Drill stopper kit for 11.5mm length C1 implant procedure | 1.97x2.83x1.02 | 116.28 | 0.26 | Closed |
| MK-CDS13 | Drill stopper kit for 13mm length C1 implant procedure | 1.97x2.83x1.02 | 115.86 | 0.26 | Closed |
| MK-LDSK | Lance Drill stoppers kit | 4.22x3.96x1.20 | 282.17 | 0.20 | Closed |
| MK-SDS06 | Drill stopper kit for 6mm length Seven implant procedure | 1.97x2.83x1.02 | 118.43 | 0.26 | Closed |
| MK-SDS08 | Drill stopper kit for 8mm length Seven implant procedure | 1.97x2.83x1.02 | 117.19 | 0.26 | Closed |
| MK-SDS10 | Drill stopper kit for 10mm length Seven implant | 1.97x2.83x1.02 | 116.64 | 0.26 | Closed |
| MK-SDS11 | Drill stopper kit for 11.5mm length Seven implant procedure | 1.97x2.83x1.02 | 116.22 | 0.26 | Closed |
| MK-SDS13 | Drill stopper kit for 13mm length Seven implant procedure | 1.97x2.83x1.02 | 115.81 | 0.26 | Closed |
The Stainless Steel Surgical Kits are reusable containers that are used to store and organize drills, instruments, and prosthetic accessories needed before, during and after the implantation and the prosthetic procedure.
The Stainless Steel Surgical Kits are also designed to hold the drills, instruments, and prosthetic accessories during the sterilization process. The kits are intended to be used in conjunction with a legally marketed, validated sterilization pouch that is intended to maintain sterility of the items placed inside the kits.
The proposed Stainless Steel Surgical Kits must be cleaned and sterilized before the first use and after each use according to the Instructions for Use (IFU) included with each kit.
The proposed Stainless Steel Surgical Kits can be divided into two types of kits: Open and Closed Kits.
Open kits consist of a lid and base with holders. Open kits cannot be closed with a lid to cover the items, but contain a lid that is always open and can be moved to a horizontal position. Open kits also do not contain an insert; the instrument holders are integrated on the base of the kit. In addition, in Open kits, the base is open and the holders can be seen through the bottom of the base.
By contrast, Closed kits consist of a lid, removable insert with holders, and base. Closed kits have a lid that can be closed. The lid has perforations that allows for steam penetration. In addition, one of the proposed Closed kits also contains a removable bath. The bath is used to hold soiled items after use during the surgical procedure.
The lid, base, insert, and bath of these kits are made of stainless steel. Silicone holders hold the kit components in each surgical kit. The role of the holders is to properly hold the items during transportation, sterilization and before use by the dentist.
N/A
FDA 510(k) Clearance Letter - Stainless Steel Surgical Kits
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.03
February 6, 2026
Dentsply Sirona Inc.
Laura Sobrin
Sr. Technical RA Manager
221 West Philadelphia Street, Suite 60W
York, Pennsylvania 17401
Re: K251614
Trade/Device Name: Stainless Steel Surgical Kits
Regulation Number: 21 CFR 880.6850
Regulation Name: Sterilization Wrap
Regulatory Class: Class II
Product Code: KCT
Dated: January 5, 2026
Received: January 5, 2026
Dear Laura Sobrin:
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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K251614 - Laura Sobrin Page 2
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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and 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 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 (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-
Page 3
K251614 - Laura Sobrin Page 3
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. ANISKO -S Digitally signed by STEPHEN A. ANISKO -S Date: 2026.02.06 12:40:51 -05'00'
Stephen Anisko
Acting 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
Page 4
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): K251614
Device Name: Stainless Steel Surgical Kits
Indications for Use (Describe)
Stainless Steel Surgical Kits
• The Stainless Steel Surgical Kits are intended for organizing, sterilizing and storing of drills, instruments, and prosthetic accessories.
• The Stainless Steel Surgical Kits are not intended to maintain sterility and are to be used in conjunction with a legally marketed, validated sterilization pouch.
Sterilization parameters
• Pre-vacuum Steam at 132 °C (270 °F) for 4 minutes with a 20 minute dry time.
• Do not exceed the worst-case validated maximum load:
| Item Number | Product Name | Dimensions (inch) | Max Load (gr) | Vent to Volume Ratio (inch-1) | Kit type |
|---|---|---|---|---|---|
| MK-0020 | Bone compression kit | 3.94x3.46x1.86 | 318.77 | 0.15 | Closed |
| MK-0056 | Scan post Int. Hexagon connection Kit | 2.60x2.83x1.02 | 143.59 | 0.29 | Closed |
| MK-0057 | Scan post Conical connection Kit | 2.60x2.83x1.02 | 146.32 | 0.29 | Closed |
| MK-0059 | Bone profiler Int. Hex. kit | 2.79x1.18x1.77 | 79.26 | 10.18 | Open |
| MK-0060 | Bone profiler coni. con. kit | 2.79x1.18x1.77 | 81.00 | 10.18 | Open |
| MK-0065 | Scan post organizer box | 2.60x2.83x1.02 | 146.32 | 0.29 | Closed |
| MK-BC101 | Drill stopper kit for C1 implant, SP | 2.60x2.83x1.02 | 144.87 | 0.29 | Closed |
| MK-BS001 | Drill stopper kit for Seven implant, SP | 2.60x2.83x1.02 | 144.64 | 0.29 | Closed |
| MK-CDS08 | Drill stopper kit for 8mm length C1 implant procedure | 1.97x2.83x1.02 | 117.27 | 0.26 | Closed |
| MK-CDS10 | Drill stopper kit for 10mm length C1 implant procedure | 1.97x2.83x1.02 | 116.70 | 0.26 | Closed |
| MK-CDS11 | Drill stopper kit for 11.5mm length C1 implant procedure | 1.97x2.83x1.02 | 116.28 | 0.26 | Closed |
| MK-CDS13 | Drill stopper kit for 13mm length C1 implant procedure | 1.97x2.83x1.02 | 115.86 | 0.26 | Closed |
| MK-LDSK | Lance Drill stoppers kit | 4.22x3.96x1.20 | 282.17 | 0.20 | Closed |
| MK-SDS06 | Drill stopper kit for 6mm length Seven implant procedure | 1.97x2.83x1.02 | 118.43 | 0.26 | Closed |
| MK-SDS08 | Drill stopper kit for 8mm length Seven implant procedure | 1.97x2.83x1.02 | 117.19 | 0.26 | Closed |
| MK-SDS10 | Drill stopper kit for 10mm length Seven implant | 1.97x2.83x1.02 | 116.64 | 0.26 | Closed |
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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.
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:
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FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
Page 6
510(k) SUMMARY for Stainless Steel Surgical Kits, K251614
Page 1 of 9
1. Submitter Information:
Dentsply Sirona Inc.
221 West Philadelphia Street
Suite 60W
York, PA 17401
Contact Person: Laura Sobrin
Telephone Number: 717-849-4434
Email: laura.sobrin@dentsplysirona.com
Date Prepared: February 4, 2026
2. Device Name:
• Proprietary Name: Stainless Steel Surgical Kits
• Classification Name: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
• CFR Number: 21 CFR 880.6850
• Device Class: Class II
• Product Code: KCT
3. Predicate and Reference Devices:
The predicate and reference devices identified are the following:
| Type of Device | Device Name | 510(k) | Company Name |
|---|---|---|---|
| Predicate | Surgical and Prosthetic Trays | K220791 | Dentsply Sirona Inc. |
| Reference | Washtrays | K231144 | Dentsply Sirona Inc. |
| Reference | Biotech Dental Kits | K212068 | Biotech Dental, SAS |
4. Device Description:
The Stainless Steel Surgical Kits are reusable containers that are used to store and organize drills, instruments, and prosthetic accessories needed before, during and after the implantation and the prosthetic procedure.
The Stainless Steel Surgical Kits are also designed to hold the drills, instruments, and prosthetic accessories during the sterilization process. The kits are intended to be used in conjunction with a legally marketed, validated sterilization pouch that is intended to maintain sterility of the items placed inside the kits.
The proposed Stainless Steel Surgical Kits must be cleaned and sterilized before the first use and after each use according to the Instructions for Use (IFU) included with each kit.
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Page 2 of 9
The proposed Stainless Steel Surgical Kits can be divided into two types of kits: Open and Closed Kits.
Open kits consist of a lid and base with holders. Open kits cannot be closed with a lid to cover the items, but contain a lid that is always open and can be moved to a horizontal position. Open kits also do not contain an insert; the instrument holders are integrated on the base of the kit. In addition, in Open kits, the base is open and the holders can be seen through the bottom of the base.
By contrast, Closed kits consist of a lid, removable insert with holders, and base. Closed kits have a lid that can be closed. The lid has perforations that allows for steam penetration. In addition, one of the proposed Closed kits also contains a removable bath. The bath is used to hold soiled items after use during the surgical procedure.
The lid, base, insert, and bath of these kits are made of stainless steel. Silicone holders hold the kit components in each surgical kit. The role of the holders is to properly hold the items during transportation, sterilization and before use by the dentist.
5. Intended Use and Indications for Use
Stainless Steel Surgical Kits
• The Stainless Steel Surgical Kits are intended for organizing, sterilizing and storing of drills, instruments, and prosthetic accessories.
• The Stainless Steel Surgical Kits are not intended to maintain sterility and are to be used in conjunction with a legally marketed, validated sterilization pouch.
Sterilization parameters
• Pre-vacuum Steam at 132 °C (270 °F) for 4 minutes with a 20 minute dry time.
• Do not exceed the worst-case validated maximum load:
| Item Number | Product Name | Dimensions (inch) | Max Load (gr) | Vent to Volume Ratio (inch-1) | Kit type |
|---|---|---|---|---|---|
| MK-0020 | Bone compression kit | 3.94x3.46x1.86 | 318.77 | 0.15 | Closed |
| MK-0056 | Scan post Int. Hexagon connection Kit | 2.60x2.83x1.02 | 143.59 | 0.29 | Closed |
| MK-0057 | Scan post Conical connection Kit | 2.60x2.83x1.02 | 146.32 | 0.29 | Closed |
| MK-0059 | Bone profiler Int. Hex. kit | 2.79x1.18x1.77 | 79.26 | 10.18 | Open |
| MK-0060 | Bone profiler coni. con. kit | 2.79x1.18x1.77 | 81.00 | 10.18 | Open |
| MK-0065 | Scan post organizer box | 2.60x2.83x1.02 | 146.32 | 0.29 | Closed |
| MK-BC101 | Drill stopper kit for C1 implant, SP | 2.60x2.83x1.02 | 144.87 | 0.29 | Closed |
| MK-BS001 | Drill stopper kit for Seven implant, SP | 2.60x2.83x1.02 | 144.64 | 0.29 | Closed |
| MK-CDS08 | Drill stopper kit for 8mm length C1 implant procedure | 1.97x2.83x1.02 | 117.27 | 0.26 | Closed |
| MK-CDS10 | Drill stopper kit for 10mm length C1 implant procedure | 1.97x2.83x1.02 | 116.70 | 0.26 | Closed |
Page 8
Page 3 of 9
| Item Number | Product Name | Dimensions (inch) | Max Load (gr) | Vent to Volume Ratio (inch-1) | Kit type |
|---|---|---|---|---|---|
| MK-SDS11 | Drill stopper kit for 11.5mm length Seven implant procedure | 1.97x2.83x1.02 | 116.22 | 0.26 | Closed |
| MK-SDS13 | Drill stopper kit for 13mm length Seven implant procedure | 1.97x2.83x1.02 | 115.81 | 0.26 | Closed |
6. Comparison of Technological Characteristics
The proposed Surgical Kits have the same intended use, similar Indications for Use, and incorporate the same fundamental technology as the predicate device, Surgical and Prosthetic Trays (K220791), with similar general design and functionality.
The proposed and predicate (K220791) devices share the same sterilization method (pre-vacuum) and sterilization parameters. Both devices are intended to be used with an FDA cleared sterilization single pouch.
Both the proposed and predicate devices are reusable. The difference in reuse life is based on the number of cycles validated (50 cycles) for the proposed kits when compared to the cycles validated on the predicate device (200 cycles).
An overview of the similarities and differences between the proposed, predicate, and reference devices is given in Table 6.1.
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Page 4 of 9
Table 6.1: Similarities and Differences between the proposed, predicate, and reference devices
| Element | Proposed Device Stainless Steel Surgical Kits | Predicate Device Surgical and Prosthetic Trays (K220791) | Reference Device Washtrays (K231144) | Reference Device Biotech Dental Kits 2-piece metal trays (K212068) |
|---|---|---|---|---|
| Manufacturer | MIS Implants Technologies Ltd. (part of Dentsply Sirona) | Dentsply Implants Manufacturing GmbH (part of Dentsply Sirona) | Dentsply Implants Manufacturing GmbH (part of Dentsply Sirona) | Biotech Dental, SAS |
| Intended Use | Intended for organizing, sterilizing and storing of drills, instruments, and prosthetic accessories | Intended for organizing, sterilizing and storing of instruments | Intended for organizing, cleaning, sterilizing, and storing of instruments | Intended to allow sterilization of the group medical devices |
| Product code | KCT | KCT | KCT | KCT |
| Regulation # | 21 CFR 880.6850 | 21 CFR 880.6850 | 21 CFR 880.6850 | 21 CFR 880.6850 |
| General design and Components | Closed kit: Perforated stainless steel box (lid and base) with removable stainless steel insert, on which holders made of silicone are assembled. One kit contains a removable stainless steel bath. Open Kit: Stainless steel kit (lid and base) without an insert. The base integrates the silicone holders. | Perforated plastic box (lid and base) with removable plastic insert, on which holders made of silicone are assembled. The base also holds instruments. | Perforated stainless steel box (lid and base) which incorporates a small stainless steel basket, and an anodized aluminum insert with large stainless steel basket underneath. The insert contains thermoplastic holders with stainless steel springs, and the small basket contains a silicone mat. | 2 piece stainless steel tray with silicone holders |
Page 10
Page 5 of 9
| Element | Proposed Device Stainless Steel Surgical Kits | Predicate Device Surgical and Prosthetic Trays (K220791) | Reference Device Washtrays (K231144) | Reference Device Biotech Dental Kits 2-piece metal trays (K212068) | Comparison |
|---|---|---|---|---|---|
| Dimensions (inch) | 1.97 x 2.83 x 1.022.60 x 2.83 x 1.022.79 x 1.18 x 1.773.94 x 3.46 x 1.864.22 x 3.96 x 1.20 | 5.4 x 3.9 x 2.47.3 x 5.5 x 2.4 | 10.83 x 6.93 x 2.32 | 1.57 x 1.97 x 0.79(40 mm x 50 mm x 20 mm) | predicate device (K220791). The holders are assembled in the insert, and they hold the items in place.The difference is that predicate device (K220791) allows for placement of items in the base, whereas the proposed Stainless Steel Surgical Kits hold all items within the insert only.The proposed Open kits are similar to the reference device K212068 in design concept and materials.The reference device K231144 also shares similar materials compared to the proposed Closed kits, which is also a perforated kit.Similar.The dimensions of the proposed Stainless Steel Surgical Kits are within the range of the predicate and reference devices. |
Page 11
Page 6 of 9
| Element | Proposed Device Stainless Steel Surgical Kits | Predicate Device Surgical and Prosthetic Trays (K220791) | Reference Device Washtrays (K231144) | Reference Device Biotech Dental Kits 2-piece metal trays (K212068) | Comparison |
|---|---|---|---|---|---|
| Raw materials | Lid, Base, Insert, and Bath: AISI 304LHolders: Colored Silicone | Base, Lid and Insert: PPSU polyphenylsulfone - Radel R-5000Holders – Colored Silicone | • Metal Grid Base: Stainless steel 1.4301• Metal grid base feet: Silicone• Large and small basket: Stainless steel 1.4303• Lid with Handle: Stainless Steel 1.4310• Silicone mat (inside the small basket): Colored Silicone• Instrument Holders (within the Overlay): PEEK, with Stainless steel springs• Overlay: Anodized aluminum alloy | Base and Lid: Stainless Steel AISI 304LHolders: Medical grade silicone | SimilarSame material as the predicate device for the silicone holders.Similar stainless steel materials as the reference devices. |
| Air permeance | Allows moist heat (steam) penetration to achieve sterilization | Allows moist heat (steam) penetration to achieve sterilization | Allows moist heat (steam) penetration to achieve sterilization | Allows moist heat (steam) penetration to achieve sterilization | Same |
| Maximum number of instruments | 5 - 20 instruments | 22 - 56 instruments | 38 - 76 instruments | 3 instruments | Similar and within range of the predicate and reference devices, combined.The maximum number of instruments that can be loaded in the proposed Stainless Steel Surgical Kits is lower than that of the predicate device (K220791). |
Page 12
Page 7 of 9
| Element | Proposed Device Stainless Steel Surgical Kits | Predicate Device Surgical and Prosthetic Trays (K220791) | Reference Device Washtrays (K231144) | Reference Device Biotech Dental Kits 2-piece metal trays (K212068) | Comparison |
|---|---|---|---|---|---|
| Mass of maximum load (g) | 79.26– 318.77 | 271.9 - 563.5 | 1107.3 | 39.4 | Similar and within the range of the predicate and reference devices, combined. The weight difference of the mass of maximum load of the proposed Stainless Steel Surgical Kits does not affect the sterilization process and sterility assurance level (SAL) of 10-6 as demonstrated by the sterilization validation. |
| Vent to Volume Ratio (in-1) | 0.15 – 10.18 | 0.033 – 0.046 | 2.54 | 0.9500 cm2/cm3 (2.413 in-1) | Similar or higher when compared to the predicate and reference devices.The difference in the vent to volume ratio (in-1) does not affect the sterilization process and sterility assurance level (SAL) of 10-6 as demonstrated by the sterilization validation. |
| Sterility | Provided non-sterile (to be steam sterilized by the end user) | Provided non-sterile (to be steam sterilized by the end user) | Provided non-sterile (to be steam sterilized by the end user) | Provided non-sterile (to be steam sterilized by the end user) | Same |
| Sterilization Method | Dynamic air removal (pre-vacuum) | Dynamic air removal (pre-vacuum) | Dynamic air removal (pre-vacuum) | Dynamic air removal (pre-vacuum) | Same |
| Sterilization Parameters | Dynamic air removal (pre-vacuum) at 132 °C (270 | Dynamic air removal (pre-vacuum) at 132 °C (270 | Dynamic air removal (pre-vacuum) at 132 °C (270 | Dynamic air removal (pre-vacuum) at 132 °C (270 | Same |
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Page 8 of 9
| Element | Proposed Device Stainless Steel Surgical Kits | Predicate Device Surgical and Prosthetic Trays (K220791) | Reference Device Washtrays (K231144) | Reference Device Biotech Dental Kits 2-piece metal trays (K212068) | Comparison |
|---|---|---|---|---|---|
| °F) for 4 minutes with a 20 minute dry time. | °F) for 4 minutes with a 20 minute dry time. | °F) for 4 minutes with a 20 minute dry time. | °F) for 4 minutes with a 20 minute dry time. | ||
| Sterile barrier | FDA cleared sterilization pouch (single pouch) | FDA cleared sterilization pouch (single pouch) | FDA cleared sterilization pouch (single pouch) | FDA cleared sterilization pouch (double pouch) | Same as the predicate and reference device (K231144). |
| Reusable | Yes | Yes | Yes | Yes | Same |
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7. Non-Clinical Performance Data
The proposed Stainless Steel Surgical Kits are reusable devices provided non-sterile which need to be end user cleaned and sterilized. Cleaning and sterilization of the proposed trays were validated according to the FDA guidance document, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling".
Non-clinical testing data submitted, referenced, or relied upon, including acceptance criteria and set specifications in test methodology and standards, are summarized below:
| Test Name | Test Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|---|
| Cleaning (Manual Pre-Cleaning and Automated Cleaning) validation | ANSI/AAMI ST98:2022 | To validate that the trays can be cleaned as specified on labeling | No visible soil.Residual protein: ≤ 6.4 µg/cm²Total Organic Carbon: ≤ 12 µg/cm² | Pass |
| Sterilization cycle validation and drying time validation | • ISO 17665:2024• AAMI TIR 12:2020/(R) 2023 | To validate that the trays can be sterilized via moist-heat sterilization as specified on labeling (132° C for 4 minutes)To validate that the drying time parameters are suitable | Sterility assurance level (SAL) of ≤ 10-6No visible moisture≤ 1% weight gain of packaging and absorbable materials | Pass |
| Service Life validation | • ANSI/AAMI ST98:2022• Internal Test - visual and functional tests | To confirm that the trays can withstand simulated use and up to 50 reprocessing cycles | Internal visual and functional acceptance criteria must be met.Total Organic Carbon: ≤ 12 µg/cm² | Pass |
| Transportation validation | • ASTM D4332-22• ASTM D4169-23e1• Internal Test – visual and functional tests | To confirm that the packaging protects the device during simulated distribution | Internal visual and functional acceptance criteria must be met. | Pass |
| Cytotoxicity testing | ISO 10993-5:2009/(R)2022 | To confirm that no cytotoxic substances are released after 50 or 51 reprocessing cyclesTo confirm that no cytotoxic residuals of detergent remain on the device after 8 simulated use cycles | Inhibition of cell proliferation must be at or below 30% compared to untreated cultures | Pass |
8. Conclusion
The conclusions drawn from the non-clinical test data and evaluation support that the proposed Stainless Steel Surgical Kits are as safe, as effective and perform as well as the legally marketed predicate device Dentsply Sirona Surgical Trays (K220791).
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§ 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).