Surgical and Prosthetic Trays
Device Facts
| Record ID | K261935 |
|---|---|
| Device Name | Surgical and Prosthetic Trays |
| Applicant | Dentsply Sirona, Inc. |
| Product Code | KCT · General Hospital |
| Decision Date | Sep 4, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6850 |
| Device Class | Class 2 |
Indications for Use
The Surgical and Prosthetic Trays are intended for organizing, sterilizing, and storing of instruments. The Surgical and Prosthetic Trays are not intended to maintain sterility and are to be used in conjunction with a legally marketed, validated sterilization pouch.
Device Story
Reusable perforated containers; store/organize instruments before, during, and after implant surgery; hold instruments during steam sterilization. Constructed of PPSU Radel and silicone; some models include stainless steel latches. Used in clinical settings; operated by healthcare staff. Devices provided non-sterile; require cleaning and pre-vacuum steam sterilization (132°C, 4 min, 20 min dry) before use. Used with FDA-cleared sterilization pouches. Output is organized, sterilized instrument set. Benefits include standardized instrument management and effective sterilization processing.
Clinical Evidence
No clinical data. Bench testing only: cleaning validation (ANSI/AAMI ST 98:2022, ASTM F3208-20, ASTM F3293-18), sterilization/drying validation (ISO 17665:2024, AAMI TIR12:2020), cytotoxicity (ISO 10993-5:2009), simulated use, service life (200 cycles), and transportation testing (ISTA 2A, ASTM D4169-22). All tests passed.
Technological Characteristics
Materials: PPSU Radel, colored silicone, stainless steel. Sensing/Actuation: None (mechanical). Energy: Steam sterilization (pre-vacuum). Dimensions: Various (e.g., 264x150x61 mm to 100x50x23 mm). Connectivity: None. Sterilization: Pre-vacuum steam (132°C, 4 min). Reusable (200 cycles).
Indications for Use
Indicated for organizing, sterilizing, and storing surgical and prosthetic instruments in a clinical setting. Not intended to maintain sterility; must be used with a validated sterilization pouch.
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
- Surgical and Prosthetic Trays (K220791)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
September 4, 2026
Dentsply Sirona, Inc.
Rebecca Sporer
Principal Regulatory Affairs Specialist
221 W. Philadelphia St.
Suite 60W
York, Pennsylvania 17401
Re: K261935
Trade/Device Name: Surgical and Prosthetic Trays
Regulation Number: 21 CFR 880.6850
Regulation Name: Sterilization Wrap
Regulatory Class: Class II
Product Code: KCT
Dated: June 9, 2026
Received: June 9, 2026
Dear Rebecca Sporer:
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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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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 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-
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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.
ANISKO -S
Digitally signed by
STEPHEN A. ANISKO -
S
Date: 2026.09.04
13:01:39 -04'00'
Stephen Anisko
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
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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)
K261935
Device Name
Surgical and Prosthetic Trays
Indications for Use (Describe)
The Surgical and Prosthetic Trays are intended for organizing, sterilizing, and storing of instruments.
The Surgical and Prosthetic Trays 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: 68015277
Product Name: Astra Tech Implant System EV Surgical Tray
Maximum Load (gram): 719.5
Vent to Volume Ratio (inch-1): 0.031
Item Number: 68017201
Product Name: Astra Tech Implant System EV Surgical Tray GS
Maximum Load (gram): 719.5
Vent to Volume Ratio (inch-1): 0.031
Item Number: 24349
Product Name: Surgical Tray
Maximum Load (gram): 1024.8
Vent to Volume Ratio (inch-1): 0.033
Item Number:31036503
Product Name: Ankylos Surgical Kit Manual ABC
Maximum Load (gram): 810.6
Vent to Volume Ratio (inch-1): 1.53
Item Number: 31036513
Product Name: Ankylos Surgical Kit Manual AB
Maximum Load (gram): 810.6
Vent to Volume Ratio (inch-1): 1.53
Item Number: 31036523
Product Name: Ankylos Surgical Kit Motor AB Reamer
Maximum Load (gram): 810.6
Vent to Volume Ratio (inch-1): 1.53
Item Number: 31036530
Product Name: Ankylos Surgical Kit Guided Surgery
Maximum Load (gram): 810.6
Vent to Volume Ratio (inch-1): 1.53
FORM FDA 3881 (8/23)
Page 1 of 2
PSC Publishing Services (301) 443-6740
EF
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Item Number: 31036531
Product Name: Ankylos Surgical Kit Tray Guided Surgery (empty)
Maximum Load (gram): 810.6
Vent to Volume Ratio (inch-1): 1.53
Item Number: 31036540
Product Name: Ankylos Surgical Kit Tray ABC Empty
Maximum Load (gram): 810.6
Vent to Volume Ratio (inch-1): 1.53
Item Number: 31036542
Product Name: Ankylos Surgical Kit Tray motor AB Reamer Empty
Maximum Load (gram): 810.6
Vent to Volume Ratio (inch-1): 1.53
Item Number: 31036165
Product Name: Ankylos Prosthetic Tray Mini
Maximum Load (gram): 64
Vent to Volume Ratio (inch-1): 0.24
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 2 of 2
PSC Publishing Services (301) 443-6740
EF
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Dentsply Sirona
221 West Philadelphia Street
Suite 60W
York, PA 17401
[LOGO]
Dentsply
Sirona
# 510(k) SUMMARY
## K261935
Surgical and Prosthetic Trays
### 1. Submitter Information:
Dentsply Sirona
221 West Philadelphia Street
Suite 60W
York, PA 17401
Contact Person:
Rebecca Sporer
Telephone Number:
717-849-4793
Email address:
rebecca.sporer@dentsplysirona.com
Date Prepared:
2 September 2026
### 2. Device Name:
Proprietary Name:
Surgical and Prosthetic Trays
Classification Name:
Sterilization Wrap Containers, Trays, Cassettes & Other
Accessories
CFR Number:
21 CFR 880.6850
Device Class:
Class II
Product Code:
KCT
### 3. Predicate Device:
The predicate device identified is the following:
| Primary Predicate Device Name | 510(k) | Company Name |
| --- | --- | --- |
| Surgical and Prosthetic Trays | K220791 | Dentsply Sirona |
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# 4. Description of Device:
The Surgical and Prosthetic Trays are reusable perforated containers that are intended to store and organize the instruments needed before, during and after implant surgery procedure as well as holding the instruments during sterilization.
The Surgical and Prosthetic Trays are intended to be used in conjunction with a legally marketed, validated sterilization pouch that is intended to maintain sterility of the drills and instruments placed inside the trays.
The proposed Surgical and Prosthetic Trays must be cleaned and sterilized before the first use and after each use according to the Instructions for Use (IFU) included with each tray.
# 5. Indications for Use:
The Surgical and Prosthetic Trays are intended for organizing, sterilizing and storing of instruments.
The Surgical and Prosthetic Trays 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:
| Product Name | Article Number | Max Load (g) | Vent to Volume Ratio (in-1) |
| --- | --- | --- | --- |
| Astra Tech Implant System EV Surgical Tray | 68015277 | 719.5 | 0.031 |
| Astra Tech Implant System EV Surgical Tray GS | 68017201 | 719.5 | 0.031 |
| Surgical Tray | 24349 | 1024.8 | 0.033 |
| Ankylos Surgical Kit Motor AB Reamer | 31036523 | 810.6 | 1.53 |
| • Ankylos Surgical Kit Tray motor AB Reamer Empty | 31036542 | 810.6 | 1.53 |
| Ankylos Surgical Kit Manual AB | 31036513 | 810.6 | 1.53 |
| Ankylos Surgical Kit Manual ABC | 31036503 | 810.6 | 1.53 |
| • Ankylos Surgical Kit Tray ABC Empty | 31036540 | 810.6 | 1.53 |
| Ankylos Surgical Kit Guided Surgery | 31036530 | 810.6 | 1.53 |
| • Ankylos Surgical Kit Tray Guided Surgery (empty) | 31036531 | 810.6 | 1.53 |
| Ankylos Prosthetic Tray Mini | 31036165 | 64 | 0.24 |
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## 6. Comparison of Technological Characteristics:
An overview of the similarities and differences between the proposed and predicate devices is given in Table 1.
The proposed Surgical and Prosthetic Trays have the same intended use, similar indications for use and incorporate the same fundamental technology as the predicate device (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 pouch.
With the exception of the stainless steel latches of the proposed Surgical Tray, the proposed and predicate devices share the same raw materials.
Differences lie in the dimensions of the trays, vent to volume ratio (in⁻¹), maximum load and the number of instruments intended to be stored in the trays. With the exception of the proposed Ankylos Prosthetic Tray Mini, the proposed Surgical and Prosthetic Trays are larger trays intended to hold more instruments and have a higher maximum load.
Both the proposed and predicate devices are reusable (200 cycles).
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| Table 1: Comparison of Technological Characteristics | | | |
| --- | --- | --- | --- |
| Item of Comparison | Proposed Device Surgical and Prosthetic Trays | Predicate Device Surgical and Prosthetic Trays (K220791) | Discussion |
| Manufacturer | Dentsply Implants Manufacturing GmbH (part of Dentsply Sirona) | Dentsply Implants Manufacturing GmbH (part of Dentsply Sirona) | Same |
| Product Code | KCT | KCT | Same |
| FDA Regulation # | 21 CFR 880.6850 | 21 CFR 880.6850 | Same |
| General design and components | The Astra Tech Implant System EV Surgical Trays and the Surgical Tray consist of a lid, an insert with silicone instrument holders, and a base with integrated silicone strips for instrument retention. The lid of the Astra Tech Implant System EV Surgical Trays is secured to the base with a flexible snap-fit closure, whereas the Surgical Trays utilize stainless steel latches to secure the lid to the base. The Ankylos Surgical Trays consist of a lid and base with modular silicone instrument holders. The Ankylos Prosthetic Tray Mini consists of a base and cover. | Consist of a lid, an insert with silicone instrument holders, and a base with integrated silicone strips for instrument retention. The lid is secured to the base with a flexible snap-fit closure. | The proposed and predicate Surgical and Prosthetic Trays share the same fundamental design, consisting of a lid, base, and insert with silicone instrument holders, except for the Ankylos Prosthetic Tray Mini, which consists of a preformed base and cover. The predicate device utilizes a flexible snap-fit closure, while the proposed devices incorporate equivalent closure mechanisms, including snap-fit closures and stainless-steel latches. Additional differences, such as modular instrument holders, represent minor design variations that do not affect intended use or performance. |
| Dimensions | Astra Tech Implant System EV Surgical Trays- 264x150x61 mm (10.39x5.9x2.4 inch) Surgical Trays- 279.4x175.26x68.58mm (11x6.9x2.7 inch) | 5.4 x 3.9 x 2.4 Inches 7.3 x 5.5 x 2.4 Inches | The proposed Surgical and Prosthetic Trays are larger than the predicate trays to accommodate the instruments needed for the planned procedure. |
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| Table 1: Comparison of Technological Characteristics | | | |
| --- | --- | --- | --- |
| Item of Comparison | Proposed Device Surgical and Prosthetic Trays | Predicate Device Surgical and Prosthetic Trays (K220791) | Discussion |
| | Ankylos Surgical Trays-215x166x60 mm (8.46x6.54x2.36 inch) Ankylos Prosthetic Tray Mini-100x50x23 mm (3.94x1.97x0.91 inch) | | |
| Raw materials | Astra Tech Implant System EV Surgical Trays- Base, Lid and Insert- PPSU Radel; Holders-Colored Silicone Surgical Tray-Lid PPSU Radel and stainless steel; Base and Insert PPSU Radel; Holders and Mat Colored Silicone Ankylos Surgical Trays- Base, Lid and Insert- PPSU Radel; Holders-Colored Silicone Ankylos Prosthetic Tray Mini-Cover and Base PPSU Radel | Base, Lid and Insert- PPSU polyphenylsulfone- Radel Holders- Silicone | Similar. PPSU Radel and Colored Silicone materials for all components of the trays with the exception of the Surgical Tray. The only difference is the latches of the Surgical Tray lid are made of stainless steel and are used to latch the lid to the base. |
| Air permeance | Allows moist heat (steam) penetration to achieve sterilization | Allows moist heat (steam) penetration to achieve sterilization | Same |
| Maximum number of instruments | Astra Tech Implant System EV Surgical Trays- 78 instruments Astra Tech Implant System EV Surgical Trays GS- 61 instruments Surgical Tray- 70 instruments | 22-26 instruments | The proposed trays are larger trays used to accommodate the higher number of instruments used during the surgical procedure. |
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| Table 1: Comparison of Technological Characteristics | | | |
| --- | --- | --- | --- |
| Item of Comparison | Proposed Device Surgical and Prosthetic Trays | Predicate Device Surgical and Prosthetic Trays (K220791) | Discussion |
| | Ankylos Surgical Trays- 48-68 instruments Ankylos Prosthetic Tray Mini- 3 instruments | | |
| Maximum load (g) | Astra Tech Implant System EV Surgical Trays- 719.5 Surgical Tray- 1024.8 Ankylos Surgical Trays- 810.6 Ankylos Prosthetic Tray Mini- 64 | 271.9 – 563.5 | The maximum load varies per tray. The proposed trays are larger trays that can accommodate more instruments. |
| Vent to Volume Ratio (in^{-1}) | Astra Tech Implant System EV Surgical Trays 0.031 Surgical Tray- 0.033 Ankylos Surgical Trays- 1.53 Ankylos Prosthetic Tray Mini- 0.24 | 0.033-0.046 | Vent to volume ratio (in^{-1}) is similar or higher than that of the predicate device (K220791), thus allowing more room for the moist heat steam to enter the proposed Trays and sterilize the drills and instruments inside. |
| Sterility | 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) | Same |
| Sterilization Parameters | Dynamic air removal (pre-vacuum) at 132 °C (270 °F) for 4 minutes with a 20-minute dry time | Dynamic air removal (pre-vacuum) at 132 °C (270 °F) for 4 minutes with a 20-minute dry time | Same |
| Sterile Barrier | FDA cleared sterilization pouch (single pouch) | FDA cleared sterilization pouch (single pouch) | Same |
| Reusable | Yes | Yes | Same |
| Reprocessing cycles | 200 cycles | 200 cycles | Same |
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## 7. Non-Clinical Performance Data
The proposed Surgical and Prosthetic Trays are reusable devices provided non-sterile and intended to be cleaned and steam sterilized by the end user prior to first use and between uses. Cleaning and sterilization processes, of the proposed trays, were validated in accordance with 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 in Table 2.
| Table 2: Summary of Non-Clinical Performance Testing | | | | |
| --- | --- | --- | --- | --- |
| Test name | Standard/test method followed | Purpose | Acceptance criteria | Results |
| Cleaning Validation | ANSI/AAMI ST 98:2022, ASTM F3208-20, ASTM F3293-18 | To validate that the trays can be cleaned as specified on the labeling. | No visible soil. Residual protein: <6.4 μg/cm² Total Organic Carbon: <12 μg/cm² | Pass |
| Sterilization Validation and Drying Time Validation | ISO 17665:2024, AAMI TIR12:2020 | 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 ≤ 10⁻⁶ No visible moisture. ≤1% weight gain of packaging and absorbable materials. | Pass |
| Cytotoxicity Testing | ISO 10993-5:2009 | To confirm that no cytotoxic residuals of detergent remain on the device after 8 simulated use cycles. | Extracts demonstrate no cellular reactivity greater than grade 2. | Pass |
| Simulated Use Testing | ANSI/AAMI ST 98:2022 | To establish clinically relevant worst-case contamination prior to cleaning validation. | To establish clinically relevant worst-case contamination prior to cleaning validation. | Pass |
| Service Life (Reprocessing Durability) | Internal test method | To demonstrate that the trays maintain functional performance and material integrity throughout their intended service life (up to 200 reprocessing cycles). | No loss of functional performance, no material degradation, and all predefined visual and functional acceptance criteria are met. | Pass |
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| Table 2: Summary of Non-Clinical Performance Testing | | | | |
| --- | --- | --- | --- | --- |
| Test name | Standard/test method followed | Purpose | Acceptance criteria | Results |
| Transportation Testing | ISTA 2A (2011), ASTM D4169-22 | To confirm that the packaging protects the device during simulated distribution. | Internal visual and functional acceptance criteria must be met. | Pass |
### 8. Clinical Performance Data
No data from human clinical studies has been included to support performance of the proposed Surgical and Prosthetic Trays.
### 9. Conclusion
The conclusions drawn from the non-clinical test data support that the proposed Surgical and Prosthetic Trays are as safe, as effective and perform as well as the legally marketed predicate device Dentsply Sirona Surgical Trays (K220791).
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