Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray
Device Facts
| Record ID | K212932 |
|---|---|
| Device Name | Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray |
| Applicant | Nobel Biocare Services AG |
| Product Code | KCT · General Hospital |
| Decision Date | Dec 18, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6850 |
| Device Class | Class 2 |
Indications for Use
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. 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 PureSet Trays were 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).
Device Story
Reusable surgical tray system for organizing, storing, and protecting Nobel Biocare surgical/prosthetic instruments during reprocessing and clinical use. Composed of perforated stainless steel tray base, lid, and anodized aluminum plate with PEEK/stainless steel grommets. Used in healthcare facilities by clinical staff. Device does not maintain sterility; requires external FDA-cleared sterilization wrap, pouch, or container. Operates via steam sterilization (dynamic-air-removal or gravity-displacement). Protects instruments during transport and storage; facilitates organized access during implant/prosthetic procedures.
Clinical Evidence
No clinical data. Bench testing only: durability of handle/closing mechanism (250N force), packaging performance (ASTM D4169-16), simulated intrafacility transport, and repeated reprocessing (up to 500 cycles) with biocompatibility assessment (ISO 10993-1).
Technological Characteristics
Materials: Stainless steel (1.4301, 1.4303, 1.4310), PEEK, silicone elastomer, anodized aluminum. Design: Perforated single-level tray with integrated handle. Sterilization: Steam (dynamic-air-removal/gravity-displacement). Standards: ANSI/AAMI ST77:2013, ISO 10993-1, ASTM D4169-16.
Indications for Use
Indicated for use in healthcare facilities to store and organize Nobel Biocare surgical/prosthetic instruments and components during cleaning, sterilization, and implant/prosthetic treatment. Not intended to maintain sterility independently; must be used with FDA-cleared sterilization wrap, pouch, or container.
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
Submission Summary (Full Text)
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December 18, 2021
Nobel Biocare Services AG Nick Lewis Senior Regulatory Affairs Manager BOX 5190, SE-402 26, Vastra Hamngatan 1 Goteborg, SE-411 17 Sweden
Re: K212932
Trade/Device Name: Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: November 19, 2021 Received: November 19, 2021
Dear Nick Lewis:
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 (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 located 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.
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
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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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-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,
Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known)
K212932
Device Name
NobelSpeedy® Groovy / Brånemark System® Mk III TiUnite / Replace SelectTM TC PureSet™ Trav
#### Indications for Use (Describe)
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 pouch, or sterilization wrap.
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 PureSet Trays were 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 / Brânemark System® Mk III TiUnite / Replace SelectTM TC PureSet™ Tray).
| Method | Steam Sterilization (Moist Heat Sterilization)<br>for Wrapped Instruments | |
|--------------------------------------------------|---------------------------------------------------------------------------|-------------------------|
| Cycle | Dynamic-Air-Removal<br>(fractionated vacuum) | Gravity-Displacement |
| Temperature | 132°C (270°F) | 132°C (270°F) |
| Exposure time for a single-use<br>pouched device | 4 minutes (full-cycle) | 15 minutes (full-cycle) |
| Minimum drying times | 20 minutes | 30 minutes |
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Nobel Biocare. The logo consists of a red square with a stylized "N" inside it, followed by the words "Nobel Biocare" in black text. The word "Nobel" is above the word "Biocare", and there is a trademark symbol after the word "Biocare".
# 510(k) Summary K212932
Nobel Biocare NobelSpeedy®Groovy / Brånemark System® Mk III TiUnite / Replace Select™ TC PureSet™ Tray
- 1. Submitter Information:
Submitter:
| Nobel Biocare AB | |
|-----------------------|--|
| P.O. Box 5190, 402 26 | |
| Västra Hamngatan 1 | |
| Goteborg, SE-411 17 | |
| Sweden | |
Submitted By:
| Nobel Biocare Services AG | |
|---------------------------|----------------------------|
| Balz Zimmermann-Str. 7 | |
| 8302 Kloten | |
| Switzerland | |
| Contact Person: | Nick Lewis, M.Sc. |
| E-Mail: | regulatory affairs@nobelbi |
| E-Mail: | regulatory.affairs@nobelbiocare.com |
|-------------------|-------------------------------------|
| Telephone Number: | (+41) 79 941 68 17 |
| Fax Number: | (+41) 43 211 42 42 |
Date Prepared: November 18, 2021
- Device Name: 2.
- Proprietary Name: Nobel Biocare NobelSpeedy® Groovy / Brånemark System® Mk III ● TiUnite / Replace SelectTM TC PureSet™ Tray
- Common Name: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories .
- Manufacturer: Nobel Biocare Services AG ●
- CFR Number: 880.6850 ●
- Classification Name: Sterilization Wrap
- Device Class: II
- Product Code: KCT ●
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# 3. Predicate Device
# Primary Predicate Device:
- Proprietary Name: NobelActive / NobelParallel CC PureSet Trav (K181075) ●
- Common Name: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories .
- Manufacturer: Nobel Biocare Services AG .
- CFR Number: 880.6850 ●
- Classification Name: Sterilization Wrap
- Device Class: II
- Product Code: KCT
# Predicate Device #2:
- . Proprietary Name: Nobel Biocare N1 ™ PureSet Tray (K191475)
- Common Name: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories .
- Manufacturer: Nobel Biocare Services AG .
- CFR Number: 880.6850 .
- Classification Name: Sterilization Wrap ●
- Device Class: II ●
- Product Code: KCT ●
- 4. Description of Device:
PureSet Trays are reusable surgical trays to be used in combination with Nobel Biocare surgical instruments and components. PureSet Trays are used to organize and store the instruments and components during both surqical and reprocessing procedures.
PureSet Trays are not intended to maintain sterility on their own; they are intended to be used in conjunction with an FDA cleared sterilization wrap, pouch, or container.
All components of the PureSet Tray are perforated with an evenly-distributed hole pattern and are designed to be used for sterilization via steam sterilization. Because the PureSet Trays are perforated, an FDA-cleared sterilization wrap, pouch, or container must be used during sterilization and storage to maintain the sterility of the contents.
PureSet Trays are designed to be used with standard autoclaves used in hospitals and healthcare facilities.
# Principle of Operation / Mechanism of Action:
PureSet Trays consist of multiple components (tray base, lid, and plate) integrated into a single unit which is used to organize instruments during surgical procedures and to protect the instruments during transportation, reprocessing, and storage.
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## Accessories:
There are no accessories for the subject PureSet tray.
- 5. Indications for Use:
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.
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 PureSet Trays were 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).
| Method | Steam Sterilization (Moist Heat Sterilization) for<br>Wrapped Instruments | |
|---------------------------------------------------|---------------------------------------------------------------------------|----------------------------|
| Cycle | Dynamic-Air-Removal<br>(fractionated vacuum) | Gravity-Displacement |
| Temperature | 132°C<br>(270°F) | 132°C<br>(270°F) |
| Exposure time for a single-<br>use pouched device | 4 minutes<br>(full-cycle) | 15 minutes<br>(full-cycle) |
| Minimum drying times | 20 minutes | 30 minutes |
# 6. Technological Characteristic Comparison:
Details of the Similarities Between the Subject and Predicate Devices:
The similarities between the NobelSpeedy® Groovy / Brånemark System® Mk III TiUnite / Replace Select™ TC PureSet™ Tray (Subject Device), the Primary Predicate Device NobelActive / NobelParallel CC PureSet Tray (K181075), and Predicate Device #2 Nobel Biocare N1™ PureSet Tray (K191475) as described in Table 5.1 are as follows:
- The Intended Use statement, design aspects including tray perforation, sterilant . penetration, tray configuration, and reusability, the materials of construction, the
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sterilization methods and parameters for reprocessing (including the microbial barriers to be used), the compatibility of the tray materials with the prescribed sterilization methods, and the approach to non-clinical performance testing are all identical for the subject device and both predicate devices.
- The macro design of the subject device is identical to the primary predicate device. Both ● the subject device and the primary predicate device are single level trays which have an integrated handle. The dimensions of the subject and primary predicate devices are identical, and they have an identical volume to vent ratio.
# Details of the Differences Between the Subject and Predicate Devices:
There are no significant differences between the subject and predicate devices but there are minor differences as follows:
- The Indications for Use for the subject device is similar but not identical to both predicate . devices. It differs from the statement for the primary predicate because it includes the subject device, as well as three trays that were referenced in the Indications statement for predicate device #2. It differs from the statement for predicate device #2 because it includes the subject device, as well as minor updates to the maximum validated load for several of the referenced trays as follows:
- NobelActive / NobelParallel CC PureSet Tray (PUR0200): 1122 grams instead of O 1082 grams
- NobelReplace CC PureSet Tray (PUR0300): 1063 grams instead of 945 grams O
- NobelActive Guided PureSet Tray (PUR0600): 1143 grams instead of 1117 grams O
- NobelParallel CC Guided PureSet Tray (PUR0700): 1146 grams instead of 1120 O grams
- NobelReplace CC Guided PureSet Tray (PUR0800): 1176 grams instead of 1156 O grams
- The macro design of the subject device is similar but not identical to predicate device #2. ● Both trays are single level trays, but the subject tray has an integrated handle whereas predicate device #2 does not.
- . The dimensions of the subject device are greater than predicate device #2 due to the larger assortment of instruments used with the subject tray. As a result, the volume to vent ratio for the subject device also is greater than predicate device #2.
Table 5.1 presents a comparison of the subject device, primary predicate device, and predicate device #2 with regard to their indications for use, technology, and performance specifications.
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| Descriptive Information | Subject Device | Primary Predicate Device | Predicate Device #2 | Comparison of Subject to Predicate Devices |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| | NobelSpeedy® Groovy / Brånemark System® Mk III TiUnite / Replace Select™ TC PureSet™ Tray | NobelActive / NobelParallel CC PureSet Tray (K181075) | Nobel Biocare N1 ™ PureSet Tray (K191475) | |
| Indications for Use | Indications for Use<br>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.<br>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.<br>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 PureSet Trays were 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). | The Nobel Biocare PureSet Tray is used in healthcare facilities to store and organize Nobel Biocare surgical instruments and components during cleaning/sterilization and during implant/prosthetic treatment.<br>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 pouch or sterilization wrap.<br>Sterilization validations for the worst-case PureSet Tray included surgical instruments such as torque wrenches, implant drivers, direction indicators, drills, screw taps, screwdriver and irrigation needles. The PureSet Trays were validated for a maximum load of 1635 grams (Trefoil PureSet Tray), 1082 grams (NobelActive/NobelParallel CC PureSet Tray) and 945 grams (NobelReplace CC PureSet Tray). | 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.<br>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 pouch or sterilization wrap.<br>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 PureSet Trays were validated for a maximum load of 1635 grams (Trefoil PureSet Tray), 1082 grams (NobelActive / NobelParallel CC PureSet Tray), 945 grams (NobelReplace CC PureSet Tray), 454 grams (Nobel Biocare N1 ™ PureSet), 486 grams (Prosthetic PureSet). | The Indications for Use for the subject device is similar to both predicate devices. |
| | | Method<br>Cycle<br>Temperature<br>Exposure time for a single-use pouched device<br>Minimum drying times | Steam Sterilization (Moist Heat Sterilization)<br>Dynamic-Air-Removal (fractionated vacuum)<br>132°C (270°F)<br>4 minutes (full-cycle)<br>20 minutes | Gravity-Displacement<br>132°C (270°F)<br>15 minutes (full-cycle)<br>30 minutes |
| | | Method<br>Cycle<br>Temperature<br>Exposure time for a single-use pouched device<br>Minimum drying times | Steam Sterilization (Moist Heat Sterilization)<br>Dynamic-Air-Removal (fractionated vacuum)<br>132°C (270°F)<br>4 minutes (full-cycle)<br>20 minutes | Gravity-Displacement<br>132°C (270°F)<br>15 minutes (full-cycle)<br>30 minutes |
| | Method | Steam Sterilization (Moist Heat Sterilization for Wrapped Instruments) | | |
| | Cycle | Dynamic-Air-Removal (fractionated vacuum) | Gravity-Displacement | |
| | Temperature | 132°C (270°F) | 132°C (270°F) | |
| | Exposure time for a single-use pouched device | 4 minutes (full-cycle) | 15 minutes (full-cycle) | |
| | Minimum drying times | 20 minutes | 30 minutes | |
| Descriptive Information | Subject Device | Primary Predicate Device | Predicate Device #2 | Comparison of Subject to Predicate Devices |
| Intended Use | NobelSpeedy® Groovy / Brånemark System® Mk III TiUnite / Replace Select™ TC PureSet™ Tray<br>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. | NobelActive / NobelParallel CC PureSet Tray (K181075)<br>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 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. | Nobel Biocare N1™ PureSet Tray (K191475)<br>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 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. | The Intended Use for the subject device is identical to both predicate devices. |
| Device Design / Construction / Materials | | | | |
| Representative Picture | Image: NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray | Image: NobelActive / NobelParallel CC PureSet Tray | Image: Nobel Biocare N1 PureSet Tray | The macro design of the subject device is identical to the primary predicate device. |
| Macro Design | Single level tray with grommets and a basket for holding tooling in specific locations and covering lid with integrated handle. | Single level tray with grommets and a basket for holding tooling in specific locations and covering lid with integrated handle. | Single level tray with grommets and a basket for holding tooling in specific locations and covering lid (without handle). | |
| Dimensions (LxWxH) | 276.1mm x 176mm x 47mm | 276.1mm x 176mm x 47mm* | 122.1mm x 115mm x 45.6mm | The dimensions of the subject device are identical to the primary predicate device. |
| Tray Perforation | Evenly distributed hole pattern | Evenly distributed hole pattern | Evenly distributed hole pattern | Subject device is identical to both predicate devices. |
| Volume to Vent Ratio | 29.4 | 29.4* | 11.4 | The volume to vent of the subject device is identical to the primary predicate device. |
| Configuration | Perforated bases, lids and PEEK Luvocom grommets | Perforated bases, lids and PEEK Luvocom grommets | Perforated bases, lids and PEEK Luvocom grommets | Subject device is identical to both predicate devices.…
