(270 days)
Not Found
No
The device description and performance studies focus on the physical properties and reprocessing capabilities of a surgical instrument tray, with no mention of AI or ML.
No
The device is described as a system for organizing, cleaning, sterilizing, and storing surgical instruments, and for guiding surgical protocols, not for treating or diagnosing a medical condition.
No
Explanation: The device is described as trays for organizing, cleaning, sterilizing, and storing instruments. It does not perform any diagnostic function.
No
The device description clearly states it is a physical product made of stainless steel, anodized aluminum alloy, PEEK, and silicone, used for organizing, cleaning, sterilizing, and storing instruments. It undergoes physical performance testing like sterilization, drying, cleaning, and load tests.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "organizing, cleaning, sterilizing and storing of instruments." This relates to the handling and preparation of surgical instruments, not the diagnosis of diseases or conditions using samples from the human body.
- Device Description: The description details the physical components and function of the trays for holding and organizing instruments during cleaning and sterilization. There is no mention of analyzing biological samples or providing diagnostic information.
- Performance Studies: The performance studies focus on the device's ability to withstand cleaning, sterilization, and use cycles, as well as its structural integrity and lack of cytotoxicity. These are relevant to a reusable medical device used in surgical settings, not an IVD.
- Key Metrics: The key metrics (SAL, protein/hemoglobin levels, cell proliferation inhibition) are related to the effectiveness of cleaning and sterilization and the biocompatibility of the materials, which are not metrics typically associated with IVDs.
IVD devices are specifically designed to perform tests on specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not perform such tests.
N/A
Intended Use / Indications for Use
Washtrays are intended for organizing, cleaning, sterilizing and storing of instruments.
The Washtrays are not intended to maintain sterility and are to be used in conjunction with a legally marketed, validated sterilization pouch or a sterilization container.
Product codes (comma separated list FDA assigned to the subject device)
KCT
Device Description
The proposed Washtrays are used to store and organize dental implant surgical instruments needed during implant surgery, as well as hold instruments during cleaning and sterilization. The Washtrays are not intended to maintain sterility and are to be used in conjunction with a legally marketed, validated sterilization pouch or sterilization container.
The proposed Washtrays consist of a stainless-steel perforated tray equipped with baskets and a lid with a handle. The large basket comprises instrument holders inserted in an anodized aluminum alloy Overlay printed with visual symbols for correct positioning of the designated instruments such as drills and taps.
The designated instruments are placed in the Overlay in the Instrument holders which are made with PEEK and have a stainless steel spring to hold the instruments in place. The Overlay guides the user through the surgical protocol for implant placement. The small basket with its own small lid and silicone mat inside is used to store the instruments which can be disassembled prior to cleaning. The metal grid base has silicone feet to prevent the Washtrays from slipping/sliding when placed on a surface.
The outer dimensions for all Washtrays is the same, 10.83 x 2.32 inches. The inner arrangement of the baskets varies between the Washtrays.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare facilities
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Test Name: Sterilization Cycle Validation
Test Methodology: ANSI/AAMI/ISO 17665-1:2006/(R)2013, ISO 17665-2:2009
Purpose: To validate that the trays can be sterilized via moist-heat sterilization as specified on labeling (132° C for 4 minutes)
Acceptance Criteria: Sterility assurance level (SAL) of
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 16, 2024
Dentsply Sirona Rebecca Sporer Principle Regulatory Affairs Specialist 221 West Philadelphia Street Suite 60W York, Pennsylvania 17401
Re: K231144
Trade/Device Name: Washtrays Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT, Dated: December 11, 2023 Received: December 12, 2023
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.
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).
1
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 OS 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.
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 medical devices and radiation-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-regulatoryassistance/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,
Colin O'neill -S Colin O'Neill, M.B.E.
Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K231144
Device Name
Washtrays
Indications for Use (Describe)
Washtrays are intended for organizing, cleaning, sterilizing and storing of instruments.
The Washtrays are not intended to maintain sterility and are to be used in conjunction with a legally marketed, validated sterilization pouch or a sterilization container.
Sterilization parameters
Pre-vacuum Steam at 132 ℃ (270 °F) for 4 minutes with a 20-minute dry time. Do not exceed the worst-case validated maximum load:
| Product name | Article
Number | Dimensions
Length x
Width x
Height (in) | Maximum Load
(g) | Vent to Volume Ratio
(in-1) |
|---------------------------------------------|-------------------|--------------------------------------------------|---------------------|--------------------------------|
| OmniTaper Washtray | 68015271 | | 1107.3 | 2.54 |
| OmniTaper Washtray GS | 68015354 | | 1107.3 | 2.54 |
| PrimeTaper Washtray | 68015323 | 10.83
x | 1107.3 | 2.54 |
| PrimeTaper Washtray GS | 68017267 | 6.93
x | 1107.3 | 2.54 |
| Washtray
Astra Tech Implant System EV | 31071000 | 2.32 | 1107.3 | 2.54 |
| Washtray
GS Astra Tech Implant System EV | 31071020 | | 1107.3 | 2.54 |
| Ankylos Washtray | 31036600 | | 1107.3 | 2.54 |
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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3
Dentsply Sirona Inc. 221 West Philadelphia Street, Suite 60W York, PA 17401
Image /page/3/Picture/1 description: The image shows the logo for Dentsply Sirona. The logo consists of a stylized leaf-like shape on the left, followed by the text "Dentsply" on the top line and "Sirona" on the bottom line. The text is in a simple, sans-serif font and is aligned to the right of the leaf-like shape.
SECTION 5. 510(k) SUMMARY Washtravs K231144
5.1 Submitter Information:
Dentsply Sirona Inc.
221 West Philadelphia Street Suite 60W York, PA 17401
Contact Person: Rebecca Sporer Telephone Number: 717-353-1150 Fax Number: 717-849-4343 Email: corporate-ra@dentsplysirona.com
Date Prepared: January 12, 2024
5.2 Device Name:
| Proprietary Name: | Washtrays |
|---|---|
| Classification Name: | Sterilization Wrap Containers, Trays, Cassettes & Other |
| Accessories | |
| CFR Number: | 21 CFR 880.6850 |
| Device Class: | Class II |
| Product Code: | KCT |
5.3 Predicate Device:
The predicate device identified is the following:
| Predicate Device Name | NobelSpeedy® Groovy / Brånemark System® Mk III TiUnite / Replace
SelectTM TC PureSet™ Tray |
|-----------------------|-----------------------------------------------------------------------------------------------|
| 510(k) | K212932 |
| Company Name | Nobel Biocare AB |
| Classification Name: | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| CFR Number: | 21 CFR 880.6850 |
| Device Class: | Class II |
| Product Code: | KCT |
5.4 Device Description:
The proposed Washtrays are used to store and organize dental implant surgical instruments needed during implant surgery, as well as hold instruments during cleaning and sterilization. The Washtrays are not intended to maintain sterility and are to be used in conjunction with a legally marketed, validated sterilization pouch or sterilization container.
4
The proposed Washtrays consist of a stainless-steel perforated tray equipped with baskets and a lid with a handle. The large basket comprises instrument holders inserted in an anodized aluminum alloy Overlay printed with visual symbols for correct positioning of the designated instruments such as drills and taps.
The designated instruments are placed in the Overlay in the Instrument holders which are made with PEEK and have a stainless steel spring to hold the instruments in place. The Overlay guides the user through the surgical protocol for implant placement. The small basket with its own small lid and silicone mat inside is used to store the instruments which can be disassembled prior to cleaning. The metal grid base has silicone feet to prevent the Washtrays from slipping/sliding when placed on a surface.
The outer dimensions for all Washtrays is the same, 10.83 x 2.32 inches. The inner arrangement of the baskets varies between the Washtrays. Table 5.1 gives an overview of all Washtray configurations.
| Product name | Part number | Dimensions
Length x
Width x
Height (in) | Max load
(g) | Vent to
volume ratio
(in⁻¹) |
|-------------------------------------------|-------------|--------------------------------------------------|-----------------|-----------------------------------|
| OmniTaper Washtray | 68015271 | | 1107.3 | 2.54 |
| OmniTaper Washtray GS | 68015354 | 10.83 | 1107.3 | 2.54 |
| PrimeTaper Washtray | 68015323 | X | 1107.3 | 2.54 |
| PrimeTaper Washtray GS | 68017267 | 6.93 | 1107.3 | 2.54 |
| Washtray Astra Tech Implant System® EV | 31071000 | 2.32 | 1107.3 | 2.54 |
| Washtray GS Astra Tech Implant System® EV | 31071020 | | 1107.3 | 2.54 |
| Ankylos Washtray | 31036600 | | 1107.3 | 2.54 |
Table 5.1: Washtray configurations
5
5.5 Indications for Use
The Washtrays are intended for organizing, cleaning, sterilizing and storing of instruments.
The Washtrays are not intended to maintain sterility and are to be used in conjunction with a legally marketed, validated sterilization pouch or a sterilization container.
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 | Dimensions
Length x Width
x Height (in) | Maximum
Load
(g) | Vent to
Volume Ratio
(in-1) | Element | Proposed Device
Washtrays
(K231144) | | | | | Predicate Device
NobelSpeedy® Groovy / Brånemark System® Mk III
TiUnite / Replace Select™ TC PureSet™ Tray
(K212932) | Discussion |
|-------------------------------------------|---------------------------|-----------------------------------------------|------------------------|-----------------------------------|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|--------------------------------------------|---------------------|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| OmniTaper Washtray | 68015271 | | 1107.3 | 2.54 | Indications for
Use | The Washtrays are intended for organizing, cleaning,
sterilizing and storing of instruments.
The Washtrays are not intended to maintain sterility and
are to be used in conjunction with a legally marketed,
validated sterilization pouch or a sterilization container.
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: | | | | | Nobel Biocare PureSet Trays are used in healthcare
facilities to store and organize Nobel Biocare
surgical/prosthetic instruments and components during
cleaning/sterilization and during implant/prosthetic
treatment.
Nobel Biocare PureSet Trays are not intended on their
own to maintain sterility; they are intended to be used in
conjunction with a legally marketed, validated, FDA
cleared sterilization container, sterilization pouch, or
sterilization wrap. | Same uses but the proposed
Washtrays are validated for
one sterilization parameter. |
| OmniTaper Washtray GS | 68015354 | | 1107.3 | 2.54 | | Product name | Article
Number | Dimensions
(Length x Width x
Height) | Maximum
Load (g) | Vent to
Volume
Ratio (in³) | Sterilization validations for the worst-case PureSet Tray
included surgical instruments such as torque wrenches,
implant drivers, direction indicators, drills, screw taps,
screwdrivers, and irrigation needles. The
PureSetTrayswere validated for a maximum load of
1635 grams
(Trefoil PureSet Tray), 1122 grams (NobelActive /
NobelParallel CC PureSet Tray), 1063 grams
(NobelReplace CC PureSet Tray), 454 grams (Nobel
Biocare N1™ PureSet Tray), 486 grams (Prosthetic
PureSet Tray), 1143 grams (NobelActive Guided
PureSet Tray), 1146 grams (NobelParallel CC Guided
PureSet Tray), 1176 grams (NobelReplace CC Guided
PureSet Tray), and 1035 grams (NobelSpeedy® Groovy
/ Brånemark System® Mk III TiUnite / Replace
Select™ TC PureSet™ Tray). | |
| PrimeTaper Washtray | 68015323 | 10.83
X | 1107.3 | 2.54 | | OmniTaper
Washtray | 68015271 | 10.83 in
x | 1107.3 | 2.54 | | |
| PrimeTaper Washtray GS | 68017267 | 6.93
X | 1107.3 | 2.54 | | OmniTaper
Washtray GS | 68015354 | 6.93 in
x | 1107.3 | 2.54 | | |
| Washtray Astra Tech Implant System® EV | 31071000 | | 1107.3 | 2.54 | | PrimeTaper
Washtray | 68015323 | 2.32 in | 1107.3 | 2.54 | | |
| Washtray GS Astra Tech Implant System® EV | 31071020 | 2.32 | 1107.3 | 2.54 | | PrimeTaper
Washtray GS | 68017267 | | 1107.3 | 2.54 | | |
| Ankylos Washtray | 31036600 | | 1107.3 | 2.54 | | Washtray
Astra Tech
Implant
System® EV | 31071000 | | 1107.3 | 2.54 | | |
| | Washtray GS
Astra Tech | 31071020 | | 1107.3 | 2.54 | | | | | | | |
5.6 Comparison of Technological Characteristics
An overview of the similarities and differences between the proposed and predicate device is given in Table 5.6.1.
The proposed Washtrays and the predicate device NobelSpeedy® Groovy / Brånemark System® Mk III TiUnite / Replace SelectTM TC PureSet™ Tray (K212932) have the same intended use, same sterilization method (Pre-Vacum) and parameters, and are made of the same materials (stainless steel, silicone and PEEK). The proposed Washtrays have the same configuration, with an evenly distributed hole pattern, similar to the predicate device.
The use of the Washtrays has been validated through performance, biocompatibility and sterilization testing. There are only minor differences between the proposed and the predicate device. The height of the proposed Washtrays is slightly different when compared to the predicate device. The proposed Washtrays are larger in height than the predicate device which results in a difference in the vent to volume ratio. When compared to the predicate device, the proposed Washtrays have a larger maximum sterilization load. The minor differences in dimension (height), vent to volume ratio, and weight do not impact the sterility, as substantial equivalence was demonstrated through sterilization testing which confirms a SAL level of 10-6.
To maintain sterility the proposed Washtrays are to be used in conjunction with a legally marketed, validated sterilization pouch or a sterilization container. In addition to this, the predicate device can also be used in conjunction with a legally marketed wrap. The proposed Washtrays sterilization validation confirms that the dry time is the same when using a sterilization container compared to the recommended wrap for the predicate device, and that a SAL level of 10-6 is achieved.
The proposed device is only validated for pre-vacuum steam sterilization. Unlike the predicate device, the proposed Washtrays are not intended to be sterilized via gravity displacement and therefore this method is not validated nor referenced in the Instructions for Use.
6
Table 5.6.1: Technological Characteristics Comparison Table
7
| Element | Proposed Device
Washtrays
(K231144) | | | | Predicate Device
NobelSpeedy® Groovy / Brånemark System® Mk III
TiUnite / Replace Select™ TC PureSet™ Tray
(K212932) | | | Discussion | | |
|------------------------|---------------------------------------------------------------------------------------------|----------|--|--------|-------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| | Implant
System® EV | | | | | Method
Cycle
Temparature
Exposure
time for the
single-use
pouched
device
Minimum
drying times | Dynamic-Air-
Removal
(fractionated
vacuum) | Steam Sterilization (Moist Heat
Sterilization
for Wrapped Instruments)
Gravity-
Displacement | | |
| | Ankylos
Washtray | 31036600 | | 1107.3 | 2.54 | | | | | |
| Intended Use | The Washtray are intended for organizing, cleaning, sterilizing and storing of instruments. | | | | | | | | The Nobel Biocare PureSet Tray is intended for use in healthcare facilities to store and organize Nobel Biocare surgical instruments and components during cleaning/sterilization and during implant/prosthetic treatment. The Nobel Biocare PureSet Trays are not intended on their own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization container, sterilization pouch, or sterilization wrap. Sterilization validations for the worst-case Nobel Biocare PureSet Tray (276.1 mm x 176 mm x 78 mm) included surgical instruments such as torque wrenches, implant drivers, direction indicators, drills, etc. | Similar
Predicate device shares the same device functionality of organizing, cleaning, sterilizing and storing instruments as proposed device. |
| | | | | | | | | 132°C
(270°F) | 132°C
(270°F) | |
| | | | | | | | | 4 minutes
(full-cycle) | 15 minutes
(full-cycle) | |
| | | | | | | | | 20 minutes | 30 minutes | |
| Manufacturer | Dentsply Sirona | | | | | Nobel Biocare AB | | | Different | |
| Product code | KCT | | | | | KCT | | | Same | |
| Device class | II | | | | | II | | | Same | |
| Classification
Name | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | | | | | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | | | Same | |
8
| Element | Proposed Device
Washtrays
(K231144) | Predicate Device
NobelSpeedy® Groovy / Brånemark System® Mk III
TiUnite / Replace SelectTM TC PureSet™ Tray
(K212932) | Discussion |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| CFR Number
and Name | 21 CFR 880.6850, Sterilization wrap | 21 CFR 880.6850, Sterilization wrap | Same |
| Dimensions | 10.83 in x 6.93 in x 2.32 in
(276.1mm in x 176mm in x 59 mm) | 276.1mm x 176mm x 47mm | Different |
| Tray
Perforation | Evenly distributed hole pattern | Evenly distributed hole pattern | Same |
| Configuration | Perforated metal grid base with baskets and lids,
instrument holders and outer lid with handle. | Perforated bases, lids and PEEK Luvocom grommets | Same |
| Materials | Washtray:
• Metal Grid Base-Stainless steel 1.4301
• Metal grid base feet-Silicone
• Large basket - Stainless steel 1.4303
• Small Basket - Stainless steel 1.4303
• Lid with Handle-Stainless Steel 1.4310
• Silicone mat (inside the small basket)-Silicone
• Instrument Holders – PEEK with stainless steel spring
• Overlay – Anodized aluminum | • PureSet Tray:
o Tray (including basket / lid / handle / sheet metal
parts): Stainless steel (1.4301, 1.4303, 1.4310)
o Grommets: PEEK, Stainless steel 1.4310
o Tray / Basket Closures: Stainless steel 1.4310, PEEK
o Feet: Silicone elastomer
• PureSet Tray Plate: Anodized aluminum | Same |
| Mass of
maximum
sterilization
load | 1107.3g | 1035g | Different |
| Volume to
Vent
Ratio | 2.54 in-1 (10.36 mm-1) | 29.4 | Different |
| Sterility | Non-sterile | Non-sterile | Same |
| Sterilization
Method | Moist heat (steam) | Moist heat (steam) | Same |
| Element | Proposed Device
Washtrays
(K231144) | Predicate Device
NobelSpeedy® Groovy / Brånemark System® Mk III
TiUnite / Replace SelectTM TC PureSet™ Tray
(K212932) | Discussion |
| Sterilization
Parameters | Pre vacuum,
At 132°C for 4 minutes with a 20 minute dry time | • Pre-Vacuum:
o Temp 132°C (270° F)
o Exposure Time 4 minutes
o Pre-vacuum: 4 times